The Alliance for Regenerative Medicine (ARM) is the leading international advocacy organization dedicated to realizing the promise of regenerative medicines and advanced therapies. ARM promotes legislative, regulatory, reimbursement and manufacturing initiatives to advance this innovative and transformative sector, which includes cell therapies, gene therapies and tissue-based therapies. Early products to market have demonstrated profound, durable and potentially curative benefits that are already helping thousands of patients worldwide, many of whom have no other viable treatment options. Hundreds of additional product candidates contribute to a robust pipeline of potentially life-changing regenerative medicines and advanced therapies. In its 13-year history, ARM has become the voice of the sector, representing the interests of 400+ members worldwide, including small and large companies, academic research institutions, major medical centers and patient groups. To learn more about ARM or to become a member, visit www.alliancerm.org.
Looking to gain extensive exposure to hundreds of top decision makers in the advanced therapies sector? Contact Brittany Miller at bmiller@alliancerm.org to learn more about the benefits of supporting this year’s meeting.
Asimov, the Boston-based synthetic biology company focused on mammalian cell engineering, recently launched our industry-leading cell lines for stable viral vector production. Originally developed at MIT, our platform radically advances the design and manufacture of gene therapies and biologics. By integrating state-of-the-art genetic engineering, computational biology, and automation, Asimov enables breakthrough solutions to long-standing challenges in industry. www.asimov.com
BioIVT provides high-quality personalized biospecimen solutions and research services to life science and diagnostic industries. Recognized as an industry leader, we specialize in control and disease state samples including human and animal tissue, cell and gene therapy products, blood, and other biofluids, as well as ADME contract research services from standalone bioanalytical support through tiered in vitro studies with submission-ready reports to customized consulting. www.bioivt.com
Catalent Cell & Gene Therapy is an industry-leading technology, development, manufacturing, and analytical testing partner for advanced therapeutics. With deep expertise in viral vector development, scale-up and manufacturing for gene therapies and viral vaccines, Catalent is a full-service partner for Plasmid DNA, Adeno-associated Virus (AAV), Lentivirus and other viral vectors, and oncolytic viruses. Its comprehensive Cell Therapy portfolio includes a wide range of expertise across a variety of cell types including CAR-T, TCR, TILs, NKs, iPSCs, and MSCs. As an experienced and innovative partner, it has a global network of dedicated development, clinical and commercial manufacturing facilities, including an EMA- and FDA-licensed viral vector facility, fill/finish capabilities located in the U.S. and Europe and full service analytical testing. With integrated solutions for plasmid DNA, viral vectors and autologous and allogeneic cell therapies through clinical trial packaging and logistics, Catalent can provide full supply chain control as well as integrated or standalone analytical support to enable innovators to get their advanced therapies to patients faster.
Cellino is on a mission to make stem cell-based regenerative medicines accessible for all eligible patients. Stem cell- derived therapies are poised to prevent, treat, and potentially reverse diseases for which no options are available today or the current standard of care is insufficient. Cellino’s next-generation manufacturing platform combines artificial intelligence (AI) and laser technology to automate cell therapy manufacturing to reduce expenditures and overcome scaling limitations. www.cellinobio.com
Cellistic traces its origin to a single imperative: to invent and advance the technologies that enable cell therapy to reach its full potential. Through facilities purpose-built for that mission, we help clients de-risk and accelerate the development of novel cell therapies through both cell line development and manufacturing of iPSC-derived immunotherapies. Our cell line development expertise helps drive clients from an idea to an edited iPSC, leveraging precise and proven reprogramming, gene editing, and cell banking technologies along the way in a shortened timeframe. Our cell therapy manufacturing capabilities are centered on a highly efficient family of established manufacturing processes for NK cells, α/β T cells, γ/δ T cells, macrophages, and other related lineages. The combination of these two platforms ensures the highest quality starting cells are scaled and transformed as quickly as possible into clinic-ready allogeneic drug product for our clients. www.cellistic.com
Cencora has a proven history of collaborative partnership, bringing complex and transformative therapies to market. From clinical to commercial and every point between, we strive for accelerated speed to market and better outcomes. We offer:
– A full continuum of strategic consulting services, providing the right resources at the right time
– Vast provider reach and patient services experience enabling deep connection and support across key stakeholders
– Proven expertise guiding therapies through the commercialization journey within a global footprint
– A global team of SMEs eager to innovate and flex to meet your unique needs
Our 46,000+ worldwide team members contribute to positive health outcomes through the power of our purpose: We are united in our responsibility to create healthier futures.
C3i is a one-stop-shop in the development chain of cell & gene therapy. With a proven 15-year track record of success, boasting a 99% manufacturing success rate across in over 300 clinical productions, we offer tailored services to meet client needs. Our in-house, turnkey services ensure a streamlined process, eliminating the need to transfer your technology between multiple sites. We have extensive expertise in diverse cell manufacturing and deliver cost-effective solutions. Our attractive COGS, with prices 25% lower than other US/EU CDMOs, make us a fiscally sound partner. Additionally, we provide comprehensive analytical testing, including validated Qc services, for complete quality assurance. We stand out in the CDMO field through our unique shared-risk model. By investing in innovative companies and offering in-kind services, we partner with you to turn ground-breaking cell and gene therapies into reality.
The complexities of cellular and gene therapy programs present scientific and technical challenges. They are highly customized and vary greatly based on product attributes. Now, because of tremendous promise to cure many types of diseases, there is a lot of pressure to move these programs through regulatory approval faster than ever. It is therefore crucial to find a single partner of choice who offers access to a deep scientific and regulatory network and integrates the various elements of your program to achieve your milestones and make it to market on time. With over 70 years of experience, Charles River has a unique and comprehensive portfolio to support the development and execution of cellular and gene therapy programs from animal model selection to discovery and safety evaluations through to clinical and CMC testing support. www.criver.com
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. We meet patients’ needs using the latest technologies to develop and deliver innovative therapies. The company offers the broadest range of products in the industry for treating coagulation disorders, primary immune deficiencies, hereditary angioedema, respiratory disease, and neurological disorders. CSL Behring’s products are also used in cardiac surgery, burn treatment and to prevent hemolytic disease of the newborn. The company operates one of the world’s largest plasma collection networks, CSL Plasma. The parent company, CSL Limited (ASX:CSL; USOTC:CSLLY), headquartered in Melbourne, Australia, employs more than 27,000 people, and delivers its life-saving therapies to people in more than 100 countries. CSLBehring.com/Vita | Twitter.com/CSLBehring
At Dark Horse Consulting Group, we specialize in the development of cell and gene therapy products. All of our consultants have deep cell and gene therapy industry experience, spanning diverse functions including process development, device development, manufacturing, preclinical development, quality, regulatory, program management, business development, strategy, intellectual property, and financing/investor relations. Many of our consultants also bring experience from adjacent more mature sectors, including traditional biologics, small molecules, medical devices, and management consulting. As a result, we understand the unique challenges faced by cell and gene therapy developers and are able to apply best practices from other industries to address the needs of our clients. Our team of cell and gene therapy professionals bring deep technical expertise to help you tackle the unique challenges of our exciting young field. www.darkhorseconsultinggroup.com
ElevateBio is a technology-driven company built to power the development of transformative cell and gene therapies today and for many decades to come. The company has assembled industry-leading talent, built state-of-the-art facilities, and integrated diverse technology platforms, including gene editing, induced pluripotent stem cells (iPSCs), and protein, vector, and cellular engineering, necessary to drive innovation and commercialization of cellular and genetic medicines. In addition, BaseCamp is a purpose-built facility offering process innovation, process sciences, and current Good Manufacturing Practice (cGMP) manufacturing capabilities. Through BaseCamp and its enabling technologies, ElevateBio is focused on growing its collaborations with industry partners while also developing its own portfolio of cellular and genetic medicines. ElevateBio’s team of scientists, drug developers, and company builders are redefining what it means to be a technology company in the world of drug development, blurring the line between technology and healthcare. www.elevate.bio
Envision Pharma Group is a leading global technology-enabled strategic solutions partner for the life sciences industry dedicated to improving patient outcomes through our people and our technology. Envision builds market-leading technology and artificial intelligence platforms for the life sciences complemented by deep human expertise in Medical Communications, Strategic Consulting, Commercialization, HEOR/RWE, Market Access, and solutions. We work with over 200 pharma and biotech companies, including 20 of the top 20 pharmaceutical companies in the world.
FUJIFILM Irvine Scientific supports cell and gene therapy manufacturers with over 50 years of cell culture media knowledge and expertise. Our products advance the development of processes and workflows, to help users obtain optimal performance and safety of their final manufactured cells. We deliver high-performance media and expert support that can directly influence advanced cell and gene therapies. By providing innovative, first-to-market products and workflow solutions, we holistically drive and accelerate user efforts with complete media solutions for basic, translational, and clinical research, as well as commercial applications.
At Lonza Pharma & Biotech, we provide contract development and manufacturing services that enable pharma and biotech companies to bring medicines to patients in need. From the building blocks of life to the final drug product, our solutions are created to simplify your outsourcing experience and provide a reliable outcome when you expect it. Our extensive track record includes commercialization of pioneering therapies and manufacturing of a wide variety of biological and chemical drugs. We continuously invest to solve not just the current, but also the future challenges. Together, let’s bring your next medicine to life. www.lonza.com
For 30 years, Miltenyi Biotec has been a leader in the design, development, manufacture, and integration of products that enable cell and gene therapy (CGT), leading to new treatment options for patients with unmet medical needs. With technologies ranging from clinical-grade cell separation platforms to tailored cell processing protocols for the fully automated and enclosed, GMP-compliant CliniMACS Prodigy®, we offer comprehensive CGT support, including contract development and manufacturing of CGT products and tailored GMP lentiviral vectors. Our products have been used in more than 50,000 cell therapy procedures. In addition, the automated CliniMACS® Cell Separation System, in combination with high-quality MACS GMP and CryoMACS® products, has been used for the consistent generation of cellular products that are used in a wide range of clinical applications. www.miltenyibiotec.com
OmniaBio Inc. provides specialized, focused, cGMP-compliant CDMO services for cell and gene therapy (CGT) developers from pre-clinical through to commercial stage. As a CCRM subsidiary, OmniaBio is building on an established reputation in CGT manufacturing from a team and legacy that has been built over a decade. With leadership in iPSCs, immunotherapy and LVVs, OmniaBio provides a continuum of advanced process and analytical development, and manufacturing capabilities. OmniaBio’s flagship facility is located at McMaster Innovation Park in Hamilton, Ontario, Canada, and is a one-hour drive from the U.S. border. The two OmniaBio biomanufacturing plants are opening in a scaled launch between 2024 and 2026 and will total 400,000 sq ft of space featuring 47 clean rooms. This adds to the existing 40,000 sq ft of process development and cGMP space at the Toronto site, which features 10 GMP clean rooms for production of CGT products. www.omniabio.com
Ori Biotech is revolutionizing cell and gene therapy manufacturing by pioneering flexible process discovery alongside seamless transition to scalable commercialization. Ori has developed a proprietary, full stack manufacturing platform that closes, automates, standardizes and digitizes CGT manufacturing, allowing therapy developers to research, develop and bring their products to market at commercial scale on the same platform. The promise of the innovative Ori platform is to fully automate CGT manufacturing to increase throughput, improve quality and decrease costs by combining innovation across three pillars: 1) biology, 2) engineering, and 3) digital. Ori’s biology-first approach puts primary focus on the biology vs constraining the biology due to inflexible technology. This allows the Ori platform to be an enabler instead of an inhibiter to quickly getting to scale.
Precision for Medicine is the first biomarker-driven clinical research and development services organization supporting life sciences companies in the use of biomarkers essential to targeting patient treatments more precisely and effectively. Precision applies a transformational approach to clinical research that integrates clinical trial design and execution with deep scientific knowledge, laboratory expertise, data sciences, and advanced manufacturing solutions. This convergence is driving faster clinical development and approval. Precision for Medicine is part of Precision Medicine Group, with 3,400 people in 40 locations globally across North America, Europe, and Asia-Pacific.
ScaleReady is a joint venture between Bio-Techne, Fresenius Kabi, and Wilson Wolf. Bringing together proven tools and technologies for cell culture, cell activation, gene editing, and cell processing, ScaleReady provides leading therapeutic developers with the most simple, scalable, and versatile manufacturing platform in the industry. Our platform includes G-Rex® cell culture technology, the Lovo and Cue cell processing systems, and a wide range of GMP proteins, reagents, media, and gene editing technologies. www.scaleready.com
SK pharmteco is a global contract development and manufacturing organization (CDMO) with 13 offices and manufacturing facilities across the U.S., Europe, and Korea. The company partners with biopharmaceutical companies of all sizes to manufacture Active Pharmaceutical Ingredients (API) and intermediates, cell and gene therapy technologies, registered starting materials, and analytical services for the biopharmaceutical industry worldwide. SK pharmteco is a subsidiary of SK Inc. (KRX: 034730) (SK), the strategic investment company for SK Group, South Korea’s second-largest conglomerate.
As the world leader in serving science, Thermo Fisher Scientific is uniquely positioned to provide quality materials, services and support to accelerate the pace of cell and gene therapy development. We understand the complexity of this rapidly-evolving industry and have made significant investments in cGMP raw material manufacturing and drug product manufacturing capabilities to provide innovative workflow solutions. We have a newly formed cell and gene therapy business unit with a team of biologists, process development engineers and software engineers that are focused on working with our customer collaborators to help them overcome process development challenges and accelerate their cell therapy development. Partner with us to access the high-quality materials, services, and support you need from discovery to clinical research and commercial cell and gene manufacturing. Through our Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab services, Patheon, PPD and Gibco brands, we offer an unmatched combination of innovative technologies, manufacturing, and distribution capabilities. www.thermofisher.com/cellandgenetherapy
Wacker Biotech is the all-in-one CDMO partner of choice for advanced nucleic acid-based therapies. We enable customers to advance their biologics across the full manufacturing chain, from plasmid DNA (pDNA) as a starting point to the IVT of mRNA to LNP formulation. Our diverse solutions range from pDNA supply using our PLASMITEC® platform, to process development, transfer of mRNA-based processes, R&D production at small scale, and larger-scale GMP manufacturing for clinical and commercial supply. Additionally, customers benefit from a broad spectrum of LNP formulations for their mRNA-based product. In June 2024, we opened a state-of-the-art mRNA competence center in Halle, Germany, which effectively quadruples our mRNA production capacity. This complements existing capabilities at our global GMP facilities in Amsterdam, Halle and San Diego. Also complementing these sites is a dedicated R&D center in Munich, Germany with scientific experts leading innovations in pDNA manufacturing, mRNA production, LNP formulation, and analytical development. Wacker Biotech GmbH, Wacker Biotech B.V. and Wacker Biotech US Inc. are wholly owned subsidiaries of 110-year-old Wacker Chemie AG and also specialize in producing recombinant proteins based on microbial systems and Live Biotherapeutic Products.
Advanced Medicine Partners delivers what patients deserve and what regulators expect. The company provides partners with process development, manufacturing, analytical development and testing for advanced therapy products, specializing in viral vectors for gene and cell therapies. Advanced Medicine Partners leverages one of the most experienced genetic medicines teams in the industry, and its exclusive manufacturing platform consistently produces yields that are among the highest in the industry and purity profiles that push the boundaries of what’s possible. Advanced Medicine Partners’ proprietary adeno-associated virus (AAV) manufacturing process minimizes impurities and consistently generates industry-leading functional full capsid ratios. This manufacturing process prioritizes patient safety while reducing cost of goods. The company brings extensive operational experience and has manufactured upwards of 350 total non-GMP batches and supplied over 20 preclinical studies, including IND-enabling efficacy and GLP toxicology studies. The team has led CMC efforts for three globally approved gene therapies.
Akron Bio enables the advancement of cell and gene therapies through its portfolio of cytokines and media supplements, as well as its comprehensive suite of manufacturing services, including the production of plasmid DNA, precision gene-editing tools, and specialized medias. Akron partners with advanced therapy developers, providing them with critical materials and services at the scale, level of compliance, and regulatory support necessary to drive novel treatments from discovery to commercialization, thereby addressing critical unmet needs in the patient community. www.akronbiotech.com
Aldevron serves the biotechnology industry with custom production of nucleic acids and proteins. Thousands of clients use Aldevron-produced plasmids, RNA and gene editing enzymes for projects ranging from research grade to clinical trials to commercial applications. Aldevron specializes in cGMP manufacturing and is known for inventing the GMP-Source® quality system. Aldevron operates the largest cGMP plasmid DNA manufacturing facility in the world at company headquarters in Fargo, North Dakota, with additional facilities in Madison, Wisconsin, and Lincoln, Nebraska. www.aldevron.com
Andelyn Biosciences is pioneering solutions for Turning Hope into Reality (TM) as a gene therapy CDMO. Capabilities span viral vector process and analytical development, small to large scale adherent and suspension based GMP manufacturing up to 2000L. With 20+ years of experience in viral vector manufacturing, Andelyn offers access to globally recognized thought leaders with troubleshooting and characterization expertise and GMP material produced for 75+ worldwide clinical trials. In addition to producing 450+ cGMP sublots, Andelyn provides research, tox, and GMP grade plasmids Andelyn also has full quality and regulatory support and supply chain vertical integration. Its state-of-the-art 185,000 sq ft commercial manufacturing facility offers capacity across 16 production suites for customization of new programs as well as tech transfer programs, offering clinical through commercial-scale capabilities that will help accelerate innovative therapies to bring more treatments to more patients. Andelyn Biosciences is a pioneering gene therapy CDMO born out of Nationwide Children’s Hospital, where the first FDA-approved systemic gene therapy was discovered.
Ascend Advanced Therapies (Ascend) is a specialist adeno-associated virus (AAV) development partner working to bring next-generation gene therapy products to market. Carrying forward from therapeutic development, Ascend hit the ground running via operational facilities globally. With AAV roots going back to 1991, the experienced team offers unparalleled insight and collaboration when delivering products from gene to GMP. A flexible platform supports all AAV serotypes across scales with proprietary and partnered technologies and a world-class analytical toolkit. GMP manufacturing capacity was added in 2024 via the acquisition of Beacon Therapeutics, enabling the team to Aim Higher in balancing yield and quality of commercially accessible life-saving therapies.
Avid Bioservices (NASDAQ: CDMO) is a dedicated contract development and manufacturing organization (CDMO) focused on development and CGMP manufacturing of biologics. The company provides a comprehensive range of process development, CGMP clinical and commercial manufacturing services for the biotechnology, biopharmaceutical, and cell & gene therapy industries. With over 30 years of experience producing biologics, Avid’s services include CGMP clinical and commercial drug substance manufacturing, bulk packaging, release and stability testing and regulatory submissions support. For early-stage programs the company provides a variety of process development activities, including cell line development, upstream and downstream development and optimization, analytical methods development, testing and characterization. The scope of our services ranges from standalone process development projects to full development and manufacturing programs through commercialization.
Baylor Scott & White Research Institute (BSWRI) is the dedicated research and development arm of Baylor Scott & White Health, the largest not-for-profit healthcare system in Texas. BSWRI provides essential infrastructure for conducting research in various specialty areas. The GMPCMO Core Facility in Dallas operates as a contract manufacturing organization (CMO) for sponsor-driven human cellular therapies in pre-clinical development and Phase I trials. Since 1998, our 1,800-square-foot GMP facility has supported 10 clinical trials, benefitting over 200 patients. The facility features three cleanrooms with a HEPA filtration HVAC system, maintains an ISO 7 environment, and each suite includes dedicated ISO 5 biosafety cabinets.
BioCentriq is a global cell therapy Contract Development and Manufacturing Organization (CDMO) with a proven track record successfully transferring, developing, and manufacturing GMP drug product for use in clinical trials. The Executive, Technical, and Business Development teams have commercialized four unique cell therapies and translated more than 20 programs into the clinic. This expertise, coupled with phase-appropriate quality systems and a modern infrastructure have established BioCentriq as a trusted strategic partner for the development and manufacture of autologous and allogeneic cell therapies. BioCentriq’s four flexible GMP manufacturing suites are supported by fully equipped process and analytical development laboratories to ensure seamless translation from the lab to the clinic. In May 2022, BioCentriq was purchased by GC Holdings Inc. of South Korea for $73 million. As an integral member of the GC global network, through teamwork and collaboration, BioCentriq and GC Cell offer harmonized CDMO services to facilitate seamless cross-border technology transfers to improve access to and reduce the cost of life-changing cell therapies. In June 2023, BioCentriq launched its LEAP™ Advanced Therapy Platform designed to help cell therapy developers move from contract to clinic in as little as six months.
Cardinal Health Advanced Therapy Solutions brings a unique understanding of the challenges of launching and commercializing cell and gene therapies (CGTs) — and how to overcome them effectively. Our early involvement, starting with assisting biopharma in establishing the first CAR-T products in 2017, has enabled us to develop tailored solutions to simplify and streamline the complexities of CGTs. Our clinical and commercial capabilities across the product lifecycle, from regulatory consulting to cold storage and shipping, help biopharma companies manage more variables so they can focus on bringing their advanced therapy to patients.
The Cell and Gene Therapy Catapult is an independent innovation and technology organisation committed to the advancement of the cell and gene therapy industry with a vision of a thriving industry delivering life changing advanced therapies to the world. Its aim is to create powerful collaborations which overcome challenges to the advancement of the sector. With over 400 experts covering all aspects of advanced therapies, it applies its unique capabilities and assets, collaborates with academia, industry and healthcare providers to develop new technology and innovation. The Cell and Gene Therapy Catapult works with Innovate UK.
www.ct.catapult.org.uk | www.gov.uk/innovate-uk
CTI Clinical Trial and Consulting Services is a global, privately held, full-service contract research organization (CRO), delivering a complete spectrum of clinical trial and consulting services throughout the lifecycle of development, from concept to commercialization. CTI’s focused therapeutic approach provides pharmaceutical, biotechnology, and medical device firms with clinical and disease area expertise in rare diseases, regenerative medicine/gene therapy, immunology, transplantation, nephrology, hematology/oncology, neurology, infectious diseases, hepatology, cardiopulmonary, and pediatric populations. CTI is currently part of more than 30 active COVID-19 projects for treatment and prevention. CTI also offers a fully integrated multi-specialty clinical research site, as well as complete global laboratory services. Now in its third decade, it is one of the 20 largest CROs in the world with associates in more than 60 countries across six continents. The company was recently named the #1 CRO in the world for quality at the 2020 CRO Leadership Awards, outperforming nearly 30 other recognized CROs from around the world. CTI is headquartered in the Greater Cincinnati, OH area, with operations across North America, Europe, Latin America, MEA and Asia-Pacific. CTI has a passion for helping life-changing therapies succeed in chronically and critically ill patient populations and for moving medicine forward. www.ctifacts.com
Cytiva is a global provider of technologies and services that help advance and accelerate the development and manufacture of therapeutics. Cytiva’s diverse portfolio includes well-recognized brands such as ÄKTA, Amersham, Biacore, FlexFactory, HyClone, MabSelect, Whatman and Xcellerex. Cytiva brings speed, efficiency and capacity to research and manufacturing workflows, enabling the delivery of transformative medicines to patients. www.cytiva.com
Forge Biologics is a hybrid gene therapy contract manufacturing and therapeutics development company. Forge’s mission is to enable access to life changing gene therapies and help bring them from idea into reality. Forge has a 200,000 sq. ft. facility in Columbus, Ohio, The Hearth, to serve as their headquarters. The Hearth is the home of a custom-designed cGMP facility dedicated to AAV viral vector manufacturing and will host end-to-end manufacturing services to accelerate gene therapy programs from preclinical through clinical and commercial stage manufacturing. By taking a patients-first approach, Forge aims to accelerate the timelines of these transformative medicines for those who need them the most. www.forgebiologics.com
FUJIFILM Cellular Dynamics, Inc. is a leading developer and manufacturer of human cells used in drug discovery, disease modeling, custom cell services and toxicology/safety pharmacology, as well as a contract development and manufacturing organization (CDMO) services for cell therapies. FUJIFILM Cellular Dynamics’ goal is to leverage the vast knowledge and utility of human induced pluripotent stem cells (iPSCs) to advance human health and improve the quality of life for patients around the world. For life science research applications, FUJIFILM Cellular Dynamics’ iCell® products, which are available in almost any cell type and are sourced from multiple cell lines, can be applied for disease modelling and target identification as well as toxicity testing. For its partners, FUJIFILM Cellular Dynamics provides GMP-grade iPSC lines, proprietary manufacturing systems and technology, cell banking services, and reprogramming processes for cGMP manufacture of clinical-grade human cells for therapeutics.
FUJIFILM Diosynth Biotechnologies is an industry-leading cGMP Contract Development and Manufacturing Organization (CDMO) supporting the biopharmaceutical industry in the development and production of biologics, vaccines and cell and gene therapies. Our focus is to combine technical leadership in process development and cGMP manufacturing supported by a strong team of over 4,000 employees and a reputation for excellent customer service. We are a trusted partner of many clients, from early stage biotechs to large pharma. We have locations in: Watertown and Cambridge, MA | Research Triangle Park, NC | Holly Springs, NC (coming in 2024) | College Station, TX | Hillerød, Denmark | Teesside, UK | Thousand Oaks, CA. Our key service areas are: Cell Culture Services | Microbial Fermentation Services | Advanced Therapies Services (Cell Therapy, Gene Therapy, Oncolytic Viruses & Viral Vaccines) | Drug Product and Finished Goods | Analytical Services | CMC Support Services (Process Characterization, Process Validation, Formulation Development, Stability Testing & Regulatory Services)
Genezen is a contract development and manufacturing organization (CDMO) with unique technical expertise in lentiviral, retroviral, and adeno-associated viral vectors. Offering process development, GMP viral vector manufacturing, and analytics, we are dedicated to helping clients deliver safe, pure, and potent advanced therapies to the patients who need them.
Genezen drives the advancement of cell and gene therapies by providing science-driven development and manufacturing solutions. We imagine a healthier tomorrow by accelerating advanced therapies through best-in-class development and manufacturing today. We bring therapies to life.
Headquartered in Boston, Ginkgo Bioworks is building a platform to enable customers to program cells as easily as we can program computers. Our cell programming platform enables the growth of biotechnology across diverse markets, from food to fragrance to pharmaceuticals. Ginkgo has also actively supported a number of COVID-19 response efforts, including community testing, epidemiological tracing, vaccine development and therapeutics discovery. Our mammalian cell engineering foundry is ideally suited to address many outstanding problems in cell therapy, including combinatorial CAR design, synthetic promoter screening, genomic safe harbor discovery, and manufacturing. www.ginkgobioworks.com
L7 Informatic’s Enterprise Science Platform (L7|ESP) is designed to solve today’s life science and biopharmaceutical industry challenges with cell therapy processes that have limited workflow automation and critical data compliance requirements. Siloed multi-vendor IT systems make it challenging to create an integrated and validated environment for biologics manufacturing with processes involving a mixture of paper, software systems, instruments, environmental monitoring systems, and bio-process equipment. L7|ESP is a unique regulatory compliant platform that provides an integrated software platform for digitizing the sample to drug process with features including equipment integration, Electronic Batch Records (EBR), MES, CPV, inventory, sample/ location management, and analytics/statistical processing with reports and dashboard and QC LIMS. www.l7informatics.com
MaxCyte is a leading commercial cell engineering company focused on providing enabling platform technologies to advance innovative cell-based research as well as next-generation cell therapeutic discovery, development and commercialization. Over the past twenty years, we have developed and commercialized our proprietary Flow Electroporation platform, which facilitates complex engineering of a wide variety of cells. At MaxCyte, we take a collaborative partnering approach with our clients with the goal of rapidly driving our partners’ development efforts forward through to commercial use, more cost-effectively and with lowered risk. Our broad intellectual property (IP) portfolio, along with our regulatory certifications and support, offer our partners both enhanced IP protection and freedom to operate. Founded in 1998, MaxCyte is headquartered in Gaithersburg, Maryland, U.S.
McKesson Corporation is a diversified healthcare services leader dedicated to advancing health outcomes for patients. Our teams partner with biopharma companies, care providers, pharmacies, manufacturers, governments, and others to deliver insights, products and services to help make quality care more accessible and affordable. Our Cell, Gene, and Advanced Therapies platform offers best-in-class capabilities to meet the unique needs associated with bringing these innovative products to market. Our solutions span the continuum of care innovation and delivery — from early clinical development, pre-launch planning, to commercialization — and provide an integrated approach toward addressing the pain points encountered by biopharma, providers, and payers. Informed by nearly a decade of experience within the space, this ecosystem of clinical, distribution, market access, technology, and data science capabilities offers an unmatched combination of expertise that has been designed to accelerate and enhance clinical and commercial outcomes for innovators operating within the market today.
MilliporeSigma is the U.S. and Canada Life Science business of Merck KGaA, Darmstadt, Germany. Our Millipore® CTDMO services provide a streamlined experience in a single partner to mitigate the burden of managing multiple vendors, supply chain needs, and complex priorities along the drug life cycle. Our integrated Millipore® CTDMO Services combines our expertise in development, manufacturing, contract testing and technologies from pre-clinical to commercial to accelerate your milestones and breakthroughs – with one experienced partner. www.SigmaAldrich.com/ViralVector
Mix Talent was built to support the near-term goals and long-term success of pharma, biotech, digital therapeutics/medtech, and gene therapy organizations. We leverage 30 years of experience in clinical and commercial executive search, sales builds, human resources, and talent assessment to anticipate our client’s challenges and solve their complex problems, helping them grow their organization with full attention to their culture: the most powerful force for talent there is. www.mix-talent.com
There are over 10,000 known rare diseases that affect approximately 400 million people worldwide. 80% of these diseases have genetic origins and 50% affect children. Collectively, people living with a rare disease represent one of the largest underserved patient communities in the world, with less than 10% of known rare diseases having one or more approved treatments. At Pfizer, we believe that people living with a rare disease, along with the untold number of family members and caregivers who support them, deserve more. For more than thirty years, we have provided critical treatment options for patients with rare diseases. Our current focus spans four therapeutic areas, including 1) rare hematology, 2) rare endocrine/metabolic, 3) rare neurology and 4) rare cardiology. Ten Pfizer Rare Disease medicines have received regulatory approval, and we are committed to deliver a new generation of breakthrough treatments for rare diseases across a diverse range of therapeutic modalities – small molecule, large molecule/monoclonal antibodies (mAbs), gene therapies and even devices. Pfizer’s Rare Disease pipeline includes five new molecular entities in Phase 3 clinical programs, including three gene therapy programs. With our late-stage pipeline and industry-leading global commercialization and development capabilities, Pfizer has the potential to launch a new rare disease medicine every year from 2023 to 2027.
RoslinCT is a leading global contract development and manufacturing services organization (CDMO) focused on Advanced Cell and Gene Therapies. Established in 2006 and built upon the groundbreaking technology cloning of Dolly the Sheep at the Roslin Institute in 1997, RoslinCT has harnessed cutting-edge science to advance the development of human medicines. With a remarkable heritage in the field, the company has achieved significant milestones, including being among the first in the world to produce clinical-grade human pluripotent stem cells and advancing the first CRISPR edited stem cell-based therapy for a major disease to marketing authorization. Equipped with 22 purpose-built cGMP cell therapy processing suites in Edinburgh, Scotland, and Hopkinton, Massachusetts, RoslinCT provides innovative process and analytical development, cGMP clinical and commercial manufacturing for a range of cell types for both autologous and allogeneic processes, and cGMP iPSC cell line development, gene editing, and differentiation. With tailored CDMO solutions, RoslinCT enables partners to efficiently progress from development to commercialization and deliver life-saving Cell and Gene Therapies worldwide.
Sartorius is a trusted international partner of the biopharmaceutical industry. The Sartorius Advanced Therapies Unit is focused on enabling cell therapy developers to bring therapies to market faster and make them more affordable. With our specialized scientific expertise, technical know-how, and unique knowledge of the cell therapy market, we offer compelling workflow solutions consisting of single-use consumables, analytical instruments, equipment, media, and services to accelerate time-to-market and lower COGs. These solutions are specifically designed to address the unique challenges and goals of R&D, process development and manufacturing. www.sartorius.com
SmartLabs was founded in 2015 with the vision to provide infrastructure solutions for life science companies paired with a full operations program that allowed researchers to rapidly access space and begin research quickly in a well-supported and safe environment. SmartLabs created a solution to offer labs to support teams from 5 to 100+, available immediately, with no long-term commitments, or extensive upfront capital required to build out the necessary infrastructure. These integrated lab environments are designed, built, and operated by the SmartLabs team and support multifunctional research and development labs, vivariums, process development, pilot-scale manufacturing, and cGMP suites. SmartLabs designs our infrastructure to allow teams to work in lab space that is configured to their specific research needs and we can adapt and change that lab space within weeks. Companies are able to outsource the lab infrastructure while retaining their scientists, workflows, and intellectual property. www.smartlabs.com
Viralgen is a CDMO specializing in the production of recombinant Adeno-Associated Viral vectors. Viraglen was created in 2017 to respond to the unmet need for manufacturing of gene therapies, with the goal to help broaden access to these life-saving therapeutics and to contribute to the advancement of health and human welfare around the world. We have built an optimized facility in San Sebastian, Spain that maximizes throughput and efficiency of our proprietary Pro10™ suspension manufacturing platform, enabling industry-leading scalability, reproducibility, and speed to market. Through our superior technology platform, we deliver industry-leading titers and cGMP-certified quality for all AAV serotypes to our client partners, optimizing the cost-of-goods and accelerating clinical development and commercialization of life-changing genetic medicines. www.viralgenvc.com
Driven by innovation and built around one of the most prolific academic viral vector manufacturing teams, ViroCell Biologics is focused on supporting therapeutic developers using lentiviral and retroviral vectors from the earliest stages of vector design & optimization through preclinical supply to clinical GMP manufacturing. We are committed to helping companies improve safety and solve the next challenges in cell and gene therapy through our innovation research programs. Our team leverages its deep track record in vector design and innovation to help clients de-risk their products with data-driven vector selection to move to the clinic with confidence. ViroCell’s platform processes and established capabilities enable clients to accelerate their novel therapies into GMP manufacturing and release so that they can reach the clinic quickly and affordably. ViroCell’s MHRA-licensed facility is in London, from which we export globally. Our clients come from all over the world and range from academic investigators to large pharma.
ZS is a management consulting and technology firm focused on transforming global healthcare and beyond. We leverage our leading-edge analytics, plus the power of data, science and products, to help our clients make more intelligent decisions, deliver innovative solutions and improve outcomes for all. Founded in 1983, ZS has more than 12,000 employees in 35 offices worldwide. www.zs.com
Accelerated Biosciences is a regenerative medicine company. We are sourcing the highest quality immune-privileged human Trophoblast Stem Cells (hTSC) with no socio-ethical controversy. We are focused on supplying well-characterized cell types from its primary hTSC source. hTS cells are pluripotent, immune-privileged, ethically derived, virus and pathogen-free, easy to manufacture, genetically stable, and GTP compliant. We have optimized expansion to 85+ population doublings and have 40 issued patents worldwide with seven patent families in process. Accelerated Biosciences has differentiated these stem cells into iPSC, NK, neuronal, pancreatic, and hepatic cells. We are available for partnering and licensing opportunities. www.acceleratedbio.com
The American Red Cross is a nationwide leader in providing allogeneic and autologous products and services for cell and gene therapy. Our services include CAR-T collection supporting all current FDA-approved T-cell therapies, processing, and storage within our five Manufacturing Science and Technology labs. We offer allogeneic starting materials, ranging from RUO to cGMP-compliant clinical grade that can be used to support your needs from bench research to late-stage development of life-saving therapies. With a national network of apheresis collection sites, we provide a large pool of recallable donors, allowing us to scale up to meet growing needs. Our Quality Management System provides one set of standards that limits variability, ensuring the consistency of your products. The American Red Cross Cell & Gene therapy team partners with clients throughout the entire process, from basic research and discovery to safety assessment and manufacturing of late-stage clinical trials. www.redcrossblood.org/cellulartherapy
Aseptic Technologies manufactures fill & finish equipment and devices for advanced pharmaceutical manufacturing. Our core expertise lays in the innovation of aseptic filling processes for biopharmaceutical products, including cell and gene therapy products. As a member of SKAN Group, we leverage technological excellence of SKAN in the isolator design, providing integrated solutions for fill & finish projects, globally. Furthermore, we share decades of expertise in injection molding and manufacturing in cleanroom, offering customized ready-to-use assemblies for pharmaceutical processes.
At Astellas, we aim to discover, develop and deliver breakthrough gene therapies with life-changing VALUE for patients across many disease areas. We are developing one of the world’s most robust pipelines of gene therapies for genetic disorders and an end-to-end gene therapy powerhouse with industry-leading discovery, development, manufacturing and commercial capabilities. We have two candidates in clinical development for rare neuromuscular diseases: AT845, in Phase 1/2 for Pompe disease and AT132 for X-linked myotubular myopathy, currently on clinical hold. We are also working to build our portfolio across other indications including A2016 for cardiac complications associated with Friedreich ataxia, which has received FDA IND clearance. Alongside our partners, clinicians, regulatory authorities and patient communities, we strive to overcome complex challenges across the value chain so we can deliver the promise of ground-breaking science to patients.
For over 30 years, Bionique Testing Laboratories continues to be a trusted partner and global leader in Mycoplasma Testing Services for the life science industry. We offer the full range of testing services from relevant compendia (USP <63> Mycoplasma Test) to a GMP compliant Real-Time PCR assay to support the development and clinical manufacturing of cell & gene therapies. From discovery to commercialization, our capabilities extend to method development and validation of rapid microbial methods to meet global regulatory requirements. Bionique delivers testing services that meet the highest quality standards and offers the fastest turnaround times in the industry. www.bionique.com
Boston BioProducts was founded in 1995 by a group of research scientists from Harvard Medical School, with a strong passion for accelerating scientific discoveries. Since our founding, we’ve dedicated ourselves to providing high-quality reagent solutions for life science research in the biotech industry and academia. Boston BioProducts is a leading provider of biological buffers, media, and solutions for the life sciences. With nearly 30 years of experience in buffer and reagent manufacturing, our dedicated team of formulation scientists and in-house manufacturing capabilities support multiple applications including molecular biology, assay development, and bioprocessing.
CCRM, a Canadian public-private partnership established with seed funding by the Government of Canada, the Province of Ontario, and leading academic and industry partners, supports the development of regenerative medicines and associated enabling technologies, with a specific focus on cell and gene therapy. A network of academic researchers, leading companies, strategic investors and entrepreneurs, CCRM accelerates the translation of scientific discovery into new companies and marketable products for patients, with specialized teams, funding and infrastructure. CCRM sources and evaluates intellectual property from around the globe, offers various consulting services, conducts development projects with partners, and establishes new companies built around strategic bundles of intellectual property. CCRM has a fully resourced research facility used to both evaluate and advance technologies, a centre for process and analytical development and advanced manufacturing, and a cGMP facility within a 40,000 square foot space. In 2022, CCRM established OmniaBio Inc., a commercial-stage CDMO for manufacturing gene-modified cells and viral vectors for cell and gene therapies. CCRM’s model has been adopted outside of Canada in CCRM Australia and CCRM Nordic. CCRM is hosted by the University of Toronto and was launched in Toronto’s Discovery District on June 14, 2011. www.ccrm.ca
Cellipont Bioservices firmly believes that cell therapies deserve personalized and dedicated support. Our team is comprised of tenured experts within the cell therapy space, working on advancing a wide spectrum of cell modalities from CAR-T, iPSC to DCs and MSCs. Located in The Woodlands, Texas, we are strategically located near some of the best medical centers in the world. We strive to lead alongside our partners from the forefront of innovation, translating cutting-edge processes from lab to bedside.
Phoenix, Arizona is the 5th largest city in the U.S. and the fastest growing over the last decade. CBRE ranks Phoenix 5th in the Nation among Emerging Life Science Markets, 1st in Life Science Job Growth in those markets and 1st in Life Science Graduate Growth Rate in 2020, 2021 and 2023 respectively. Arizona ranks 9th in the nation for clinical trials. Phoenix offers a deep talent base, a critical mass of serial biopreneurs, globally recognized companies and institutes of research excellence to turn discovery into firms and products for preventing, early detection, treating and curing disease. Four major bioscience hubs:
Phoenix is setting the standard for technology and precision medicine driving translational discovery in areas of genomics, precision medicine, new therapy development, oncology, neuroscience, rare disease, bioinformatics and artificial intelligence.
CoJourney is an end-to-end global gene therapy CDMO that integrates the services from process development, cGMP manufacture, analytical methods development, and release testing for plasmids, viral vectors and mRNA, in our state-of-the-art facilities that meet FDA, EU, NMPA guidelines. Some points to consider, why CoJourney is a great fit for your organization to partner with to take your research into commercial scale.
Connect Labs by Wexford is a flexible, scale-in-place lab and innovation space located within Wexford Science & Technology’s dynamic and amenity-rich Knowledge Communities. Specifically created for emerging and growth companies in the life sciences, engineering, and energy industries, Connect Labs offers pre-built and furnished lab, support, and office space with a purposefully curated set of amenities, services, and shared equipment that provides companies the space to grow and attract talent; specialized equipment to leverage and conserve capital; intentional proximity to peers, experts and potential strategic partners; and opportunities to conduct research to improve the human condition and drive economic impact.
Cryoport Systems is a comprehensive supply chain partner for the life sciences focused on the global cell and gene therapy market. We excel in the specialized management of the advanced therapy supply chain through our comprehensive offerings in shipping systems, logistics, BioServices and biostorage, cryopreservation services, and consulting. Our expansive offerings are fully integrated to create a comprehensive platform that helps deliver risk mitigation, transparency, and certainty throughout the supply chain. With our platform of scalable, risk-mitigation solutions, innovative technology, and dedicated team of people, Cryoport Systems is committed to going above and beyond to enable the outcomes for the advancing cell and gene therapy industry.
CSafe offers the most comprehensive suite of thermal shipping solutions for pharmaceutical cold chain shipping needs around the world. With a “patient-first” focus, deep industry expertise and commitment to innovation, CSafe delivers industry-leading products in both the active and passive segments. CSafe is the only provider with an end-to-end portfolio including active and passive bulk air cargo, parcel, cell and gene and specialty last-mile use cases and the ability to meet the complete range of pharma cold-chain shipping requirements with industry-leading quality and reliability. Offering nearly any size, duration and temperature – CSafe is at the heart of your cold chain.
Discovery Oasis, a biotech innovation hub located in Phoenix, Arizona and adjacent to world-renowned Mayo Clinic, will create a vast ecosystem of biomanufacturing and health technology organizations within intersecting neighborhoods and amenities that encourage collaboration and convergence. At the heart of the Discovery Oasis lies a commitment to pioneering medical advancements – diagnostics that anticipate diseases before they manifest, treatments that are precisely tailored to each individual’s genetic makeup, interventions that are informed by cutting-edge data analysis and artificial intelligence, and so much more. Discovery Oasis will help to redefine the boundaries of what is achievable in healthcare, be a place where the human spirit of innovation shines brightly, and create a world where healthcare transcends expectations. We invite innovative healthcare organizations to join us in creating the forefront of medical innovation and to help shape the future of healthcare.
EBD Group’s overriding mission is to help collaborations get started across the life science value chain. Our range of partnering conferences has grown to become the largest and most productive conference platform in the industry. Each one of our seven landmark events held in key life science markets around the world is powered by our state-of-the-art partnering software, partneringONE, that enables delegates to efficiently identify and engage with new opportunities via one-to-one meetings. Today our events (BIO-Europe, BIO-Europe Spring, BioPharm America, Biotech Showcase, ChinaBio Partnering Forum, Cell & Gene Exchange, and BioEquity Europe) annually attract more than 12,000 senior life science executives who engage in over 43,000 one-to-one partnering meetings. These vital one-to-one engagements are the wellspring of deals that drive innovation in our industry. www.ebdgroup.com
Ecolab Life Sciences offers unparalleled cleaning and advanced contamination control expertise to pharmaceutical and personal care manufacturers across the globe. We deliver more than quality cleaning chemistry. We bring enhanced value to customers, helping optimize production performance and mitigate risk through quality cleaning chemistry, automated bio-decontamination solutions, and industry expertise.
Ensoma believes the future of medicine lies within us. The company is poised to create a new therapeutic category addressing diseases that impact millions around the globe, such as cancer, autoimmunity, and genetic disease. The Engenious™ platform can uniquely address these disorders by leveraging world-class technologies for in vivo delivery and genome engineering. The ability to target and reprogram both immune cells and self-renewing hematopoietic stem cells will create multicellular and multigenic medicines that solve potency and durability challenges limiting current approaches. Ensoma also has the potential to leapfrog therapies in well validated indications such as hemoglobinopathies and dramatically expand patient eligibility through its portable in vivo solutions. Ensoma is supported by top-tier investors, strategic partners and a passionate team committed to a bold, global vision for genomic medicine. www.ensoma.com
Excellos is your cell therapy CDMO, from starting material to commercialization. We provide custom GMP services to develop and manufacture cell therapies that exceed your requirements, and have ready-to-use catalog cells for early, cost-effective studies. Our deeply characterized cells help reduce variabilities in clinical responses and increase your probability of success. Current application support areas focus on TIL-based therapies, autologous and allogenic CAR-T/NK therapies and TCR therapies. Select from our customized services including targeted donor recruitment, cell collection, cell isolation, cell characterization, cell expansion, cell transduction and scale up GMP production. From Phase 1 through commercial, get the help you need with our Quality Assurance and Regulatory teams at your side. Just starting? Gain quick wins with ready-to-use catalog cells that include: leukopaks, PBMCs, cord blood units, CD34+, CD8+, CD4+, CD56+ NK, CD3+ T, CD3+ gamma delta T, and more. Located in downtown San Diego, CA. Excellos is committed to delivering the promise of cell potency. www.excellos.com
Form Bio empowers scientists to accelerate their most important discoveries. Form Bio is a new, cutting-edge research and discovery platform for life sciences professionals in industry and academia. With the most accessible, comprehensive and collaborative platform in the field, Form empowers scientists to efficiently and effectively harness the proliferation of data and computing power that has transformed the science of discovery. Form offers end-to-end integration of the discovery process with intuitive and easy-to-use software applications, combined with an open and adaptable collaborative environment. Form was developed within Colossal Biosciences and co-founded by Ben Lamm, Andrew Busey, and Kent Wakeford.
The Forum for Innovative Regenerative Medicine (FIRM) is a Japanese industrial association, with the mission to promote the expedition of regenerative medicine and cell and gene therapy industrialization. FIRM works closely with the Japanese government to develop regulatory legislation and systems to establish business environments that are most suitable for the practice of regenerative medicine and cell and gene therapy. FIRM also collaborates with academia to accelerate the translation of basic research into commercial products. Established in 2011 with merely 14 companies, FIRM currently has over 250 members comprising Japan-registered companies from diverse business sectors that are vital to regenerative medicine and cell and gene therapy industrialization, e.g. the pharmaceuticals, biotechnology, chemicals, engineering, equipment, transportation, and insurance sectors. FIRM chairs ISO/TC 276 (Biotechnology) committee and leads a working team in Japan, which is the first and sole case for industrial association of this kind in the country. FIRM’s main office is located in Tokyo. https://firm.or.jp/en
Harnessing over 60 years of experience, Germfree provides end-to-end solutions for the next generation of pharmacy, biocontainment, and biopharma cleanroom technologies. We are a leading provider of cutting-edge equipment and facilities for a variety of industries and applications. Our team ensures that our facilities and equipment are designed and built to the highest quality standards and meet the most stringent regulatory requirements. We take pride in our ability to customize our manufacturing process to suit your specific requirements, while taking care of all aspects of the process, leaving you free to focus on what matters most. At Germfree, we recognize you are doing the world’s most important work. We are here to help share the load. This is why we go beyond manufacturing to deliver turnkey solutions tailored to the unique needs of our clients. We understand the challenges you face and we are deeply committed to providing holistic, end-to-end services that address your specific concerns. www.germfree.com
GlobalData is a trusted and authoritative intelligence provider to the world’s largest industries. We cover a broad spectrum of the pharmaceutical, medical technology and healthcare value systems with in-depth analysis, forecasts, exclusive news, and robust databases all available through a fully integrated platform. Our Consulting team expands on the company’s intelligence offering and serves our clients as strategic advisors. The team combines a global presence with the extensive industry expertise required to ask the right questions and uncover strategic insights, thereby allowing our clients to anticipate and plan for the market events likely to impact their future success. www.globaldata.com
The Greater Phoenix Economic Council (GPEC), globally recognized as a top economic development organization, works to attract and grow quality businesses and advocate for the competitiveness of Greater Phoenix by providing connectivity to local resources, data to support relocation decision-making, and site selection assistance, among other services. GPEC pursues innovative companies and disruptive technologies and is intently focused on the growth of Life Sciences and Healthcare Innovation. With numerous innovation clusters, including the Phoenix Bioscience Core and the Mayo Clinic’s Discovery Oasis, Greater Phoenix’s primary core capabilities include precision oncology/medicine, medical devices, diagnostics and translational neurosciences. The region offers easy access to patients and clinical research with 66 hospitals in the metro, ranking 9th in the U.S. for clinical trial activity. With growth in life science and pharmaceutical manufacturing employment significantly outpacing national rates (2.5x and 6x, respectively), Greater Phoenix is increasingly becoming an attractive market for the Life Sciences.
Hitachi is developing businesses related to diagnosis, treatment, and digital healthcare in Japan and overseas with the purpose of “Innovating Healthcare, Embracing the Future”. In the regenerative medicine or cell and gene therapy field, our product and service offerings range from comprehensive engineering service for GMP facilities, automated cell culture equipment, digital engineering service and digital solutions (Manufacturing Execution System, value chain tracking system etc.). We provide complete cleanroom solutions for GMP facility, including design and construction, integration of cell processing equipment, maintenance, and validation.
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. We develop new innovations, drive emerging therapies forward and improve patient lives. With headquarters in Dublin, Ireland, ICON employed approximately 41,150 employees in 109 locations in 53 countries as at March 31, 2023. www.iconplc.com
Invetech helps solve commercial manufacturing challenges for the global cell and gene therapy market. With dozens of successful collaborations with the world’s leading regenerative medicine companies over the past 20 years, we’re a proven partner committed to helping you successfully transition from clinical to commercial-scale manufacturing. Our automation platforms and manufacturing systems provide Assured Pathways™ to integrated commercial manufacturing, from pre-clinical phase to large-scale manufacturing, without any substantive process changes. We configure solutions and provide the systems and resources you need to achieve large-scale, end-to-end cell and gene therapy manufacturing with a single point of accountability.
InVitria develops and commercializes high performance excipients, supplements, and media formulations that are used in cell therapy, CAR-T, gene therapy, cell-based vaccines, diagnostics, medical devices, biomanufacturing, and biopharmaceutical formulation. InVitria also offers custom media formulation services to cell therapy, vaccine, and gene therapy customers who seek blood-free and defined manufacturing systems. InVitria’s product portfolio includes recombinant albumin including optibumin, exbumin, and cellastim S as well as recombinant transferrin (Optiferrin), insulin, and transferrin supplements. InVitria’s blood-free and defined media products are optimized for specific cell types including: OptiVERO (VERO), OptiPEAK T Lymphocyte (CAR-T), and OptiPEAK HEK293t (HEK293t). www.invitria.com
Marken, UPS Healthcare Precision Logistics (formerly Marken, MNX & Polar Speed), the clinical and advanced therapy subsidiary of UPS Healthcare, unites expertise across healthcare and complex secure logistics to drive the success of our clients through innovation. Operating in 220+ countries and territories, our team of 4,000 experts orchestrate over 6.6M shipments annually at all temperature ranges across our harmonized air, sea and ground network. With a ready-now packaging catalog and global depot matrix, Marken overcomes the most complex and evolving industry challenges, mitigating risks to always make it happen. Marken offers a complete range of services that integrates drug supply, storage and distribution, advanced therapy, radio pharma logistics, patient-driven services, laboratory logistics, kitting solutions, and connected medical device management. By prioritizing quality and putting patients first, Marken ensures time and temperature-critical shipments reach those who need them most.
Moffitt Cell Therapy Facilities (CTFs) experienced team of 80+ professionals offer dynamic cell therapy manufacturing services including product development, optimization, and clinical product manufacturing to assist CTF partners in bringing their assets to clinical trials. Moffitt’s CTF staff and faculty work collaboratively with biopharmaceutical companies to translate cell therapy assets into clinic, and the CTF currently supports 19 INDs which includes biopharmaceutical partners developing cell therapies. Moffitt maintains a patient-centered focus and has extensive experience leading clinical trials in oncology. Recently, Moffitt played a pivotal role in helping bring the first tumor-infiltrating lymphocyte (TIL) product to market in melanoma with the FDA’s approval of Iovance’s Amtagvi. Apart from TIL, Moffitt’s CTF is involved in the development of a wide range of cell therapy modalities, including dendritic cell vaccines, CAR T and gamma delta T cell therapy, with programs in both solid tumors and hematological malignancies.
www.moffitt.org/cell-manufacturing
PBS Biotech develops and manufactures the most advanced single-use bioreactors for the rapidly growing cell and gene therapy market. Vertical-Wheel mixing technology uniquely provides the beneficial hydrodynamic conditions for optimal production of various therapeutic cell types. With unparalleled scalability across a full range of vessel sizes, Vertical-Wheel bioreactors enable high-quality and efficient manufacturing of therapeutic cell products, from research to clinical and even up to commercial scale. PBS Biotech also offers world-class contract research and process development services, with in-house laboratories and a dedicated Bioprocess R&D team that possesses industry-leading knowledge of a variety of cell and gene therapy applications. www.pbsbiotech.com
ReciBioPharm is a contract development and manufacturing organization (CDMO) specifically established to focus on serving companies seeking to develop and commercialize advanced therapy medicinal products (ATMPs). ReciBioPharm’s specialized CDMO capabilities include pre-clinical to clinical and commercial development and manufacture for new biological modalities encompassing technologies based on live viruses and viral vectors, live-microbial biopharmaceutical products, nucleic acid-based mRNA and plasmid DNA production. Headed by a management team and technical experts with a proven track record in both process development and contract manufacturing, ReciBioPharm offers the knowledge and resources necessary to help customers develop and manufacture promising new therapies to meet the needs of patients across the world.
Resilience (National Resilience, Inc.) was founded in 2020 to build the most trusted biomanufacturing company dedicated to broadening access to life saving vaccines and medicines. Inspired by the lack of resilient supply chains to counter disruptions and lack of scalable manufacturing processes for complex medicines, Resilience is building advanced digital and manufacturing technologies and a partnership business model to provide end-to-end biomanufacturing solutions to its customers. The company has scaled rapidly since its inception in mid 2020 and has established a network of cGMP facilities and process development laboratories in North America to provide preclinical to commercial supply of medicines in biologics, vaccines, cell therapy, viral vectors, and mRNA. With this network and a team of over 2000 employees, the company is now serving over 50 customers ranging from academic medical centers to small biotechs to big pharma companies. By continuously advancing the science of biopharmaceutical manufacturing and development, Resilience aims to free its partners from this work so that they can focus on their core competencies in discovery, development, and commercialization of medicines. Resilience’s foundation in manufacturing technology and a flexible business model has attracted nation states to partner with the company and replicate the model in their countries.
Teknova expedites breakthroughs in modern medicine by providing critical reagents for the production of molecular diagnostics, novel vaccines, and next-generation therapies. With a focus on quality, speed, and service, we manufacture custom solutions that are used at every stage of the product development workflow, from basic research to product commercialization. To meet the special demands of custom manufacturing, we built our production facilities with flexibility in mind, allowing us to quickly adapt our production setup to satisfy unique requests. Our R&D team, which focuses on increasing efficiency in gene therapy bioproduction, works with customers to define their needs, offering expertise from experimental design to guidance on manufacturing of custom reagents. With over 25 years of formulation, dispense, and QC expertise, we are able to deliver custom research and GMP products with exceptionally fast turnaround times, in formats that allow seamless integration into customer-specific workflows. www.teknova.com
Cell and gene therapy developers work with Terumo Blood and Cell Technologies when they want more than just our portfolio of automated devices. Not only do we enable unparalleled excellence in cell collections, but we also bring the expertise in automating and closing the manufacturing process of biological products. Our team of experts are dedicated to working alongside customers to help them achieve their goals from early-stage development to commercialization. www.terumobct.com/cell-therapy
Supply chain inefficiency is a major challenge facing Cell and Gene Therapy (CGT) developers, especially as products scale towards late-stage clinical development and commercialization. Since 2012, TrakCel’s software has been used to help co-ordinate activities across CGT supply chains, improving efficiency while maintaining full traceability of each product’s Chain of Identity and Chain of Custody. TrakCel’s flagship product, OCELLOS, is used by 200+ clinics worldwide with 2000+ trained users, is available in 6 languages and supports 20+ therapies (including 4 commercial therapies). Configured to clients’ exact demands, OCELLOS is a comprehensive supply chain platform that ensures every resource is managed, monitored and recorded, while our workflows ensure all activities are performed exactly as required. To complement our OCELLOS product, TrakCel also provides a full suite of CGT consultancy services. Speak to us at Meeting on the Mesa to discover how OCELLOS is making a difference to an unrivalled number of CGT companies and products across the world.
TreeFrog Therapeutics is one of the rare cell therapy biotechs that leverages biophysics to overcome critical bottlenecks of the industry, introducing new standards in terms of scalability, cell quality, transplantation efficiency, and safety/functionality of cell therapy products. Headquartered in France, with offices and labs in the U.S. and Japan, TreeFrog is advancing a pipeline of therapeutic candidates in regenerative medicine and immuno-oncology based on a disruptive cell culture platform, C-Stem™. Founded to make cell therapies accessible to large patient populations, the company is developing an iPS-derived cell therapy in Parkinson’s disease with a best-in-class profile (Phase I in 2025), building therapeutic partnerships in NK cell therapies (including Umoja Biopharma), and aims at closing comprehensive platform deals with industry leaders within the next two years. www.treefrog.fr
United BioSource LLC (UBC) is the leading provider of evidence development solutions with an expertise in uniting evidence and access. UBC helps biopharma mitigate risk, address product hurdles, and demonstrate safety, efficacy, and value under real-world conditions. Underpinned by our scientific expertise, data and analytics, and innovative technologies, we offer our customers flexible solutions generating the relevant real-world data necessary to make more informed decisions earlier, meet stakeholder requirements, and, ultimately, drive better patient outcomes.
Uniphar Group is a trusted global partner to pharma, medtech and biotech companies, working to improve patient access to medicines around the world. Uniphar’s team of experts harness the capabilities, infrastructure and expertise of a diversified pharmaceutical service provider with more than 55 years’ building success stories with 200+ multinational clients. Our understanding of the shifting market dynamics allows us to deliver tailored specialist services and solutions for our clients’ changing needs. Uniphar Pharma comprises Uniphar | Access, Uniphar | Medical, and Uniphar | Commercial – together our combined capabilities make us your trusted partner to unlock access for your patients to innovative therapies and optimise value for brands globally. Working from clinical development to commercialisation, our end-to-end services remove barriers to launch, increase access and optimise brands.
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including acute and neuropathic pain, APOL1-mediated kidney disease, IgA nephropathy, autosomal dominant polycystic kidney disease, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency.
4DMT is a gene therapy company with a transformative discovery platform – Therapeutic Vector Evolution – that enables our “disease first” approach to product discovery and development, thereby allowing us to customize our AAV vectors to target specific tissue types associated with the underlying disease. www.4dmoleculartherapeutics.com
Right. On Time. AGC Biologics is a leading global Contract Development and Manufacturing Organization (CDMO), providing world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), viral vectors and genetically engineered cells. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast track projects for orphan drugs and rare diseases. www.agcbio.com
Alexion, AstraZeneca Rare Disease, is focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and delivery of life-changing medicines. A pioneering leader in rare disease for more than three decades, Alexion was the first to translate the complex biology of the complement system into transformative medicines, and today it continues to build a diversified pipeline across disease areas with significant unmet need, using an array of innovative modalities. As part of AstraZeneca, Alexion is continually expanding its global geographic footprint to serve more rare disease patients around the world. It is headquartered in Boston, MA, US.
For the past 23 years, AllCells has been the leading provider of high-quality GMP-compliant and RUO human primary blood and bone marrow-derived cells. As the preferred supplier of global researchers and bio-manufacturing organizations, our cells are fundamental to developing cell therapies, vaccines, and therapeutics to target cancer, infectious disease, and autoimmune disease. After collecting cells and whole tissue in our on-site FDA-registered, IRB-approved, state-of-the-art donor and management facilities from a large repository of recallable, healthy donors, AllCells immediately processes fresh tissue in our adjacent labs, producing purified cell types with unparalleled quality and consistency made to fulfill custom requirements in industry-leading time. www.allcells.com
Arbor Biotechnologies is a next-generation gene editing company focused on discovering and developing potentially curative genomic medicines, with the most extensive toolbox of proprietary genomic editors in the industry to date. Founded by Feng Zhang, David Walt, David Scott, and Winston Yan, Arbor’s proprietary discovery engine is focused on discovering and evolving technologies that enable gene knockout, RT editing, precise excisions and large insertions into endogenous loci. Leveraging our wholly owned nucleases as the chassis for genetic modification, Arbor has the unique ability to work backward from disease pathology to choose the optimal editors or combination of editors for the disease in question, with a focus on areas of high unmet need. As Arbor continues to advance its pipeline toward the clinic with an initial focus in liver and CNS disease, the Company has also secured several partnerships around gene editing and ex vivo cell therapy programs to broaden the reach of its novel nuclease technology. www.arbor.bio
BlueRock Therapeutics is an engineered cell therapy company with a mission to develop regenerative medicines for intractable diseases. The company’s cell+gene platform enables the creation, manufacture, and delivery of authentic cell therapies with engineered functionality by simultaneously harnessing pluripotent cell biology and genome editing. This enables an approach where, in theory, any cell in the body can be manufactured and any gene in the genome can be engineered for therapeutic purposes. The platform is broadly applicable, but the company is focused today in neurology, cardiology, and immunology. In August 2019, the company was acquired by Bayer AG, for an enterprise value of $1B in upfront and milestone payments. For BlueRock this marks the next step in the journey to prove degenerative disease is reversible, and to bring our revolutionary new medicines to the patients who desperately need them. www.bluerocktx.com
Chardan is a global investment bank focused on companies with the potential to generate exceptional investment returns by creating real value for society. Chardan is known for high alpha generation, due to Chardan’s market impact and its history of being early to identify and communicate the fundamentals surrounding disruptive companies and their technologies. Chardan is a leader in helping genetic medicines and cell therapy companies achieve their capital markets goals. Chardan has been instrumental in company formation and private company capital raises through IPO, public market transactions and M&A, raising nearly $6 Billion for healthcare companies since 2015. Chardan covers more than 35 cell therapy and genetic medicines companies via our equity research department. Additionally, we host six conferences focused on supporting growth and investment in the space.
Evotec is a biotechnology company focused on delivering highly effective new therapeutics to patients. The Company leverages its multimodality platforms for proprietary projects and pipeline co-creation with partners including Pharma, Biotech, academics, and other healthcare stakeholders. Our business model is flexible, ranging from service-based support to strategic partnerships. Evotec offers a fully integrated end-to-end platform to move iPSC-based cell therapy projects from inception to the clinic, including in-house GMP manufacturing capabilities with clinical supply. Our proprietary iPSC-based cell therapy pipeline is one of the broadest in the industry and includes anti-tumor therapies (NK cells, macrophages, αβ T cells, γδ T cells), regenerative therapies (beta cells, cardiomyocytes, photoreceptors) and immune-modulation therapies. In addition, Evotec provides integrated drug development solutions, covering safety assessment, CMC, process and analytical development, regulatory and clinical services for autologous and allogeneic cell therapy candidates.
Fred Hutchinson Cancer Center (Fred Hutch) is an independent, nonprofit, unified adult cancer care and research center that is clinically integrated with UW Medicine, a world leader in clinical care, research and learning. Fred Hutchinson Cancer Center was created in April 2022 by the merger of long-time partners, Fred Hutchinson Cancer Research Center and Seattle Cancer Care Alliance. Together, our fully integrated research and clinical care teams seek to discover new cures for the world’s deadliest diseases and make life beyond cancer a reality. The first National Cancer Institute-designated cancer center in the Pacific Northwest, Fred Hutch’s global leadership in bone marrow transplantation, HIV/AIDS, immunotherapy and COVID-19 has confirmed our reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Based in Seattle, Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and has network affiliations with hospitals in five states. www.fredhutch.org
Labcorp is a leading global life sciences company that provides vital information to help doctors, hospitals, pharmaceutical companies, researchers and patients make clear and confident decisions. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations to improve health and improve lives. www.labcorp.com
At Miromatrix, we are pioneering a novel technology with the goal of developing fully transplantable human organs. Using the science behind our patented technology, we are working to develop bioengineered human organs in hopes of providing new options for transplantation. We believe our approach may provide an efficient way to answer the unmet need of thousands of patients across the country who will otherwise go without the transplant they need to survive and thrive.
The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) is a public-private partnership whose mission is to accelerate biopharmaceutical innovation, support the development of standards that enable more efficient and rapid manufacturing capabilities, and educate and train a world-leading biopharmaceutical manufacturing workforce, fundamentally advancing U.S. competitiveness in this industry. NIIMBL is part of Manufacturing USA®, a diverse network of federally-sponsored manufacturing innovation institutes. NIIMBL is funded through a $70 million cooperative agreement with the National Institute of Standards and Technology (NIST) in the U.S. Department of Commerce and leverages additional commitments from our partners. www.niimbl.force.com
Optima Pharma plans, develops and produces filling, closing and process technology for pharmaceutical products requiring the highest cleanliness standards, along with high process reliability and flexibility. Optima Pharma’s extensive turnkey portfolio includes pharmaceutical freeze-drying, isolators, as well as isolated filling equipment and processing isolators for cell and gene applications. As a technology partner for pharmaceutical companies, Optima Pharma improves the life of patients and users worldwide. Optima Pharma is part of the Optima Group based in Schwaebisch Hall. Optima supports companies worldwide with flexible and customer-specific filling and packaging machines for pharmaceuticals, consumer goods, paper hygiene, and medical devices markets. As a provider of solutions and systems, Optima accompanies its customers from the product idea through to successful production and throughout the entire machine life cycle. More than 2,650 experts around the globe contribute to Optima’s success. With 19 locations in Germany and abroad, our services are available worldwide. www.optima-packaging.com/en-us/pharma
Providing compassionate care since 1987, Orsini is a leader in rare disease and gene therapy pharmacy solutions, built to simplify how patients connect to advanced medicines. Through our comprehensive commercialization solutions including a nationwide specialty pharmacy, patient services hub, home infusion and nursing network, and third-party logistics provider, we work with biopharma, providers, and payors to ensure No Patient is Left Behind™.
Outpace is using unrivaled AI-powered protein design to deliver on the promise of cell therapy for solid tumors by programming cells for improved function inside the patient. The company designs proteins that solve the key barriers to efficacy: poor access to the tumor, weak survival, rapid inactivation, antigen escape, and high required doses that drive toxicity. Outpace creates modular, plug-and-play technology assets and combines them to produce cell therapies with unprecedented efficacy, advancing an internal pipeline of engineered T cell therapies for solid tumors. Lead program OPB-101, a mesothelin-specific CAR T cell therapeutic, demonstrates complete elimination of solid tumors in stringent in vivo models at very low treatment doses (as low as 50,000 cells) and is on track to enter the clinic in 2025. Outpace’s approach to internal and partnered pipeline development is optimized for rapid clinical validation of its technologies across diverse cell types, manufacturing processes, and disease indications. Outpace is based in Seattle, Washington.
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 20,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. We work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. www.parexel.com
REGENXBIO is a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy. Since its founding in 2009, REGENXBIO has pioneered the development of AAV Therapeutics, an innovative class of gene therapy medicines. REGENXBIO is advancing a pipeline of AAV Therapeutics for retinal and rare diseases, including ABBV-RGX-314 for the treatment of wet AMD and diabetic retinopathy, being developed in collaboration with AbbVie, RGX-202 for the treatment of Duchenne and RGX-121 for the treatment of MPS II. Thousands of patients have been treated with REGENXBIO’s AAV Therapeutic platform, including Novartis’ ZOLGENSMA for children with spinal muscular atrophy. Designed to be one-time treatments, AAV Therapeutics have the potential to change the way healthcare is delivered for millions of people.
Sarepta is on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development. Our vast pipeline is driven by our multi-platform Precision Genetic Medicine Engine in gene therapy, RNA and gene editing.
SVA Life Sciences partners with biopharmaceutical, biotechnology, and diagnostic leaders to bring new therapies and medical technologies to market. Leveraging decades of expertise, we guide clients through the complexities of business growth and transformation. We address challenges head-on, fostering collaboration and building lasting success. Driven by our shared passion for Life Sciences, we are dedicated to improving patient outcomes through successful innovation.
Tenaya Therapeutics is a biotechnology company committed to a bold mission: to discover, develop and deliver curative therapies that address the underlying drivers of heart disease. Tenaya is developing therapies for rare genetic disorders as well as for more prevalent heart conditions through three distinct but interrelated product platforms: Gene Therapy, Cellular Regeneration and Precision Medicine. Founded by leading cardiovascular scientists from Gladstone Institutes and the University of Texas Southwestern Medical Center, Tenaya is backed by an established syndicate of investors. www.tenayatherapeutics.com
Mercalis is an integrated life sciences commercialization partner that provides comprehensive solutions that span the entire healthcare value chain. The company partners closely with its clients to deliver an end-to-end spectrum of commercial capabilities that work together seamlessly and flexibly. Backed by proven industry expertise and results-driven technology, Mercalis provides the data and strategic insights, patient support services, and healthcare provider engagement tools to help life sciences companies successfully commercialize new products. Above all, Mercalis helps navigate the complex life sciences marketplace to accelerate value and enhance patient lives. Founded in 2000, Mercalis provides commercialization solutions to more than 500 life sciences customers and has provided access and affordability support to millions of patients. The company is headquartered in Morrisville, North Carolina.
Virica develops viral enhancers which optimize the manufacturing of viral medicines, allowing developers to economically deploy their products at scale. Virica’s Viral Sensitizer (VSE™) platform reduces production inefficiencies caused by innate antiviral defenses in manufacturing cells. Our purpose developed VSE formulations substantially increase manufacturing yields and reduce the cost of goods for a range of products, including vaccines, gene therapies, and cell therapies. www.viricabiotech.com
Amicus Therapeutics is a global, patient-dedicated biotechnology company focused on discovering, developing and delivering novel high-quality medicines for people living with rare metabolic diseases. With extraordinary patient focus, Amicus Therapeutics is committed to advancing and expanding a robust pipeline of cutting-edge, first- or best-in-class medicines for rare metabolic diseases, including an industry leading rare disease gene therapy portfolio. www.amicusrx.com
Arcellx, Inc. is a clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. Arcellx believes that cell therapies are one of the forward pillars of medicine and Arcellx’s mission is to advance humanity by developing cell therapies that are safer, more effective, and more broadly accessible. Follow Arcellx on X (Twitter) at @arcellx and LinkedIn.
The Advanced Regenerative Manufacturing Institute (ARMI) is a member-based, nonprofit organization whose mission is to advance the bioeconomy of the United States. The institute’s work will positively impact not only manufacturing but also healthcare and education & workforce development for the nation.
BioFabUSA, a program of ARMI, is a public-private partnership with more than 200 members, including companies, academic institutions and not-for profit organizations. The mission of BioFabUSA is to bring together the fundamental tenets of good manufacturing processes and the science of regenerative medicine to create regenerative manufacturing and the trained and ready workforce necessary for that manufacturing.
Aurion Biotech is a clinical-stage biotech company, whose mission is to restore vision to millions of patients with life-changing regenerative therapies. It received the prestigious Prix Galien award for best start-up in biotech. Its first candidate is for the treatment of corneal edema secondary to corneal endothelial disease, and the first clinically validated cell therapy for corneal care, having received regulatory approval in Japan. The Company has completed enrollment and dosing of its Phase 1 /2 clinical trial in the U.S. and Canada. Privately held, Aurion Biotech is backed by Deerfield, Alcon, Petrichor, Flying L Partners, Falcon Vision / KKR, and Visionary Ventures.
BioBridge Global is a nonprofit organization committed to saving and enhancing lives through the healing power of human cells and tissue. Through its subsidiaries, South Texas Blood & Tissue, QualTex and GenCure, it supports the development of advanced therapies by providing access to starting materials, testing services, biomanufacturing and clinical trials support. www.biobridgeglobal.org
BioSpherix stands at the forefront of advanced cell and tissue culture technology, dedicated to providing Cytocentric® environments designed for optimal cell care. Our flagship product, the Xvivo System, exemplifies this commitment. By harnessing our proprietary closed-system technology, the Xvivo System revolutionizes cell science and is expertly tailored to meet the demands of your GMP or R&D protocols. This modular and cost-effective system features patented self-sterilizing technology, offering a superior alternative to traditional open systems that expose cell and tissue cultures to unpredictable and non-physiologic conditions. The Xvivo System enhances operational efficiency, adapts to your evolving needs, minimizes contamination risks, and ultimately cultivates healthier, more robust cells. At BioSpherix, our philosophy is Cytocentric®: prioritizing the needs of cells above all else.
We are a metabolic therapeutics company focused on pioneering new approaches for the treatment of metabolic diseases, including type 2 diabetes and obesity. Our goal is to transform metabolic disease treatment from chronic symptomatic management to durable disease-modifying therapies that target the organ-level root causes of T2D and obesity. We believe there is significant clinical and economic opportunity for new approaches to achieve a major leap forward with new disease-modifying strategies that are designed to target and potentially reverse root cause pathology of these diseases.
We have assembled a mission-driven team of innovators and experts in the root causes of metabolic disease, all united in their passion to develop breakthrough therapies—the type of therapies we would want for ourselves, our family members, and our loved ones with these diseases.
IDT Biologika is a global biopharmaceutical contract development and manufacturing organization that specializes in the production of innovative live viral vaccines, viral vectors for gene and immune therapeutics as well as fill/finish of sterile liquid and lyophilized biologics. We offer clients a single source CDMO partner at our sites in Germany and the USA, with seamless end-to-end solutions and the ability to nimbly scale projects from development through to commercialization. This includes process development, API production, Fill/Finish, packaging, quality control and storage. IDT Biologika handles every step in manufacturing and packaging of small clinical batches as well as of products in a large-scale commercial scale.
Nordmark is a pharmaceutical company which develops and produces ingredients and drug products through all stages of the value chain. As the world’s largest manufacturer of pharmaceutical collagenase, we are able to provide translational enzymes – research and GMP Grade collagenase and neutral protease products – to simplify the path from research to clinic. Our Nordmark Biochemicals division offers quality products for nearly every cell isolation and tissue dissociation application, including our highly-purified, animal-free Collagenase AF-1 GMP Grade and Neutral Protease AF GMP Grade and our excellent Collagenase NB 6 GMP Grade for stem cell isolation. Supporting documentation and access to Drug Master Files are available.
The Gene Therapy Institute at The Ohio State University is an interdisciplinary community bringing together world-class faculty with diverse expertise in the area of gene therapy research. Through collaboration we are enabling the successful translation of basic science discoveries into new therapies that are accessible to affected populations around the globe.
With over 35 years’ experience as a global contract service organization, SGS provides integrated (bio)pharmaceutical development and testing solutions including clinical research, pharmaceutical development, biologics characterization, biosafety, and quality control testing for small and large molecules, raw materials, containers, and finished products. SGS provides a comprehensive range of biosafety services such as: virology, cell and molecular biology, microbiology, and TEM. Health Authorities (US FDA and the EMA), require companies to undergo safety testing demonstrating that cell banks, viral banks, raw materials, bulk harvests, and batches of clinical drug are free of bacteria, fungi, mycoplasma, viruses, and other potential contaminants. SGS ensures product safety in satisfying these regulatory requirements.
ASEBIO is the Spanish Bioindustry Association. ASEBIO brings together companies, associations, foundations, universities, research and technology centers that carry out activities directly or indirectly related to biotechnology in Spain. Since 1999, ASEBIO has been acting as a meeting and promotion platform for those organizations interested in stimulating the national biotechnology scene. In order to do this, ASEBIO works closely with regional, national, and European governments as well as all the social organizations interested in using biotechnology to improve quality of life, the environment, and generating skilled employment. www.asebio.com/en
Bioprocess Online offers the biopharmaceutical community access to timely insight from experts in the field, including: the latest advances in upstream and downstream bioprocessing technologies and scientific advances; key insight into global regulatory guidance from FDA, EMA, and ICH; business guidance from veteran biopharma leaders, and more. Our network of expert content contributors and supply-side partners enables our community of biopharma leaders to match solutions to their most pressing biomanufacturing challenges.
California Life Sciences (CLS) is the state’s most influential and impactful life sciences membership organization, advocating for the sector and its diverse innovation pipeline. For more than 30 years, CLS has served the community by supporting companies of all sizes, from early-stage innovators and startups to established industry leaders in the fields of biotechnology, pharmaceuticals, and medical technology. As integral components of a healthy and collaborative ecosystem, CLS also works closely with universities, academic and research institutions, the investment community, and other critical partners that promote this vibrant sector. With offices in South San Francisco, San Diego, Sacramento, Los Angeles, and Washington DC, CLS works to shape public policy, improve access to breakthrough technologies, educate lawmakers, and advance equity within our ecosystem by championing innovative solutions for some of the most pressing challenges of our times. In doing so, CLS fulfills its mission to protect and nurture California’s life sciences industry, empowering discoveries that lead to healthier lives around the world. #WeAreCaliforniaLifeSciences
Cell & Gene provides actionable information to professionals involved in the development and commercialization of cell and gene therapies. Through the original editorial published on the site — both staff-written and contributed (by subject-matter experts) — Cell & Gene facilitates the sharing of insights on challenges, trends, and best practices in this burgeoning field. Cell & Gene’s editorial scope spans the entire product lifecycle from basic research to commercialization.
E-Book: https://www.cellandgene.com/doc/scaling-cell-and-gene-therapies-0001
The enterprise tech world is evolving with newer ambitions. While the wings of innovation are spreading to newer skies, the technologists are finding it hard to play catch-up and are making sure they are in tune with the technology juggernaut. CIOCoverage aims to bridge this very gap that exists between the tech-savvy where he rests, in the very heart of it. Awakening a keen insight in you to move along the flow, CIOCoverage works to make the entrepreneurs, versatile to the sturdy technological influences. We specialise in unfurling the latest and the voguish technology, conglomerating even the meticulous details from every arena of technology. We assimilate the most required ways of contemplation to guide our dear readers to make it to the top, briskly. We intend to incubate the technological sorcery and succour our elite readers to espouse the ‘learn-from-peer’ approach, to not only curb the U.S. market but also, create a big difference as an enterprise. CIOCoverage intends to bring all the aforementioned aspects together. The industry CEOs, CXOs and the CIOs are key decision makers in their respective organization, and they need to be aware and abreast of all the latest advancements and technological surges, while also be thoughtful of the impeding pain points and help themselves evolve different ways to address those. Our editions will bring together all such areas which are considered prominent, be its technologies such as AI, Big Data, Cloud and other novel trends, or in driving innovations and practices within.
With the help of the FreeMind Group, life science companies secure non-dilutive funding for their R&D. Every year clients of FreeMind garner over $100 million, with awards ranging from hundred-thousand dollar grants to multi-million dollar programs, from federal funding sources such as NIH, DOD, BARDA, NSF, FDA, etc., as well as from private foundations. Each client of FreeMind receives ongoing support throughout the granting process. Our team learns your specific needs and goals and then builds and executes with you a long-term, multi-submission grant application strategy that maximizes your potential for success and makes non-dilutive funding a central pillar in your financing strategy. Founded in 1999, FreeMind has grown to be the largest organization of its kind working with companies all over the world. In 2021, the FreeMind Group launched FreeMind Investments, a venture capital fund that makes direct equity investments while using the non-dilutive funding review process as a means to identify promising investment opportunities. www.freemindgroup.com
Global Genes is a 501(c)(3) non-profit organization with a mission to support and drive change for the rare disease community by providing a range of programs, educational resources, and in-person events focused on advocacy, organization building, awareness, and research enablement. Global Genes also equips advocacy leaders with important tools, resources, mentoring, and connections to further advance awareness.
OLS is Ohio’s life sciences industry trade association, representing an industry that includes more than 4,200 organizations statewide. Ohio Life Sciences convenes and advocates on behalf of biotech, pharmaceuticals, medical devices, labs, digital health, gene and cell therapy, agricultural biotechnology, and research and academic institutions throughout Ohio. OLS is the voice representing and advocating for the common interests of our life sciences community.
The Medicine Maker is a print and digital publication that covers the development and manufacture of small molecules, biologics, and advanced therapies. The Medicine Maker showcases the industry’s success stories and examines its biggest points of contention. Engaging content covers the entire spectrum of drug development, keeping all medicine makers up to date with the most pressing topics, trends and technologies driving the pharma industry forward.
The Cell & Gene Meeting on the Mesa is the sector’s foremost annual conference bringing together senior executives and top decision-makers in the industry to advance cutting-edge research into cures. Tackling the commercialization hurdles facing the cell and gene therapy sector today, this meeting covers a wide range of topics from clinical trial design to alternative payment models to scale-up and supply chain platforms for advanced therapies. The program features expert-led panels, extensive partnering capabilities, exclusive networking opportunities, and 120+ dedicated presentations by the leading publicly traded and privately held companies in the space. Attracting over 2,000 attendees – over 20% of which are C-level executives – this conference enables key partnerships through more than 5,000 one-on-one meetings while highlighting the significant clinical and commercial progress in the field.
October 6-8, 2025
Arizona Biltmore
Phoenix, AZ
