October 5-7 | Arizona Biltmore
ADVI Health offers sound advice and influential solutions, guided by a clear vision at the intersection of life sciences innovation, economics, and patient impact. Science, policy strategy, and technology underpin our advice, but it is driven by game-changing data-informed perspectives that help shape markets and drive opportunity.
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
Agilent is a global leader in life science, diagnostics and analytical laboratory technologies. Leveraging more than 50 years of expertise, we create instruments, software, services and solutions that provide trusted answers to our customers’ most critical questions. We are passionate about helping them solve their most ambitious scientific challenges, increase laboratory performance, and advance the quality of life.
Akadeum Life Sciences offers the first new clinical-ready cell separation modality in over 40 years. Our microbubble technology uses gentle, flotation-based negative selection to isolate healthier, untouched cells, resulting in greater potency and persistence. Capable of scaling from millions to more than 50 billion cells, separation is completed in under an hour without specialized equipment. Akadeum delivers closed, in-bag workflows with the ability to integrate into existing instrumentation, maintaining the same process from small-scale development through large-scale GMP manufacturing. Through Akadeum’s flexible workflows and cross-functional collaboration, leading cell therapy developers are improving therapeutic performance, decreasing vein-to-vein time, lowering the risk of failure, and reducing COGS. The result is consistent, high-quality starting material that accelerates the path from development to clinical trials in a cost-effective manner. Contact info@akadeum.com to discuss your workflow needs.
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
Founded in 1998, Aldevron is a global leader in enabling the development of next-generation genomic medicines. As part of Danaher Corporation, Aldevron empowers scientists and innovators worldwide to advance transformative therapies that are redefining the future of medicine. Aldevron’s expertise and integrated solutions have supported landmark achievements—including playing a key role in manufacturing the world’s first mRNA-based personalized CRISPR therapy. With facilities in Fargo, ND, Madison, WI and Waltham, MA, Aldevron is at the forefront of accelerating scientific discovery and expanding the possibilities of gene editing, gene therapy and other breakthrough modalities. By partnering with leading researchers and organizations, Aldevron is helping to turn the promise of genomic medicine into reality for patients around the globe.
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.
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
Andelyn Biosciences is a full-service cell and gene therapy CDMO focused on the development, characterization and production of viral vectors for gene therapy. With more than 20 years of experience, Andelyn’s deep scientific expertise has resulted in the production of cGMP material for more than 450 clinical batches and 75 global clinical trials. Operating out of its development and manufacturing facilities in Columbus, Ohio, Andelyn supports its clients in developing cell and gene therapies from concept through plasmid engineering and manufacturing, process and analytical development, and cGMP clinical and commercial manufacturing. Andelyn can accelerate programs and deliver high quality products by developing and manufacturing processes on its configurable, data-driven AAV Curator Platform®, or tech transferring in an established client program. Capabilities include cGMP manufacturing for suspension processes up to a 2,000-liter and adherent processes. A rigorous quality system, regulatory support, and supply chain vertical integration further support clients in bringing their critical therapies to market.
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.
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.
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.
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
Astellas Pharma Inc. is a specialty global pharmaceutical company conducting business in more than 70 countries around the world. Our vision is to be at the forefront of healthcare change by turning innovative science into meaningful VALUE for patients. We are recognized leaders in oncology, urology, immunology and transplantation and take a long-term strategic view on creating win-win partnerships with ambitious external organizations who share our vision. Specifically, we are looking to partner in the areas of oncology, rare diseases and immuno-sciences, as well as in emerging R&D areas with a focus on new modalities such as cell and gene therapies. With patients at the forefront of everything we do, we work collaboratively to empower the brightest minds, from your organization and ours, to advance life-changing treatments for patients and define new ways to treat and potentially cure disease. Partner with us as we seek to transform the lives of the patients we serve.
Beghou focuses on “Commercialization that Works” for the life sciences industry in areas such as rare diseases, oncology, neurology, and cell and gene therapies (CGT), helping specialty therapy companies navigate the complexities of commercialization as they transition from clinical to commercial stages. For over 30 years, Beghou has been a long-term consulting and technology partner to more than 200 life sciences clients. We connect the dots between strategy, data, technology, and teams – helping clients accelerate launches, deepen customer engagement, and advance patient access. Specifically for CGT, Beghou brings strategic and operational rigor to therapy launches, particularly those with high costs, limited patient populations, and unique engagement needs. Our tailored, therapy-specific approach ensures scalable infrastructure and measurable results across providers, payers, and patients. Beghou partners with clinical and commercialization leaders to move faster, plan smarter, and deliver precision-driven growth in complex therapeutic areas.
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
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.
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.
Founded in 2009, Boston Biodevelopment is a premium regulatory strategy consulting firm led by highly experienced regulatory professionals—including former Heads of Regulatory Affairs—who provide world-class, hands-on leadership, and management throughout the development and approval of new therapies. As a signature service, we offer Interim Head of Regulatory Affairs Leadership, delivering seasoned executive leadership that ensures strategic continuity and regulatory confidence during times of transition or growth. Boston Biodevelopment has deep expertise in regulatory affairs across a wide range of therapeutic areas and rare disease in all modalities in biopharma. Our consultants excel at guiding the regulatory development of biologics, small molecules, cell and gene therapies, and gene editing products through the entire product lifecycle. Our clients turn to us when they need immediately effective regulatory professionals seamlessly embedded within their teams to advance development programs and bring the promise of life sciences to patients.
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.
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.
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.
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
CELLforCURE by SEQENS, based near Paris, is a leader in the manufacturing of Advanced Therapy Medicinal Products (ATMPs), specialized in both autologous and allogeneic cell and gene therapy solutions. With over a decade of expertise, we provide comprehensive end-to-end services, from Phase I to full-scale commercial production. Our cutting-edge “one-stop-shop” facility spans 10,000 sqm, including 2,200 sqm of GMP-certified production areas and 7 independent manufacturing lines, each equipped with 8 cleanrooms, ensuring maximum safety and compliance for every product. As a trusted comprehensive solution provider, we facilitate seamless project development, leveraging in-house Quality Control for 90% of processes to deliver drug products. With a unique blend of CDMO heritage and proven commercial manufacturing expertise, CELLforCURE is the ideal partner to help bring your innovative therapies to life, transforming groundbreaking ideas into commercial success.
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.
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.
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
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.
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.
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
CTI Clinical Trial & Consulting Services is a global, privately held research service organization, delivering a full spectrum of clinical trial and consulting services throughout the development lifecycle – from concept to commercialization. CTI has deep expertise in cell and gene therapy (CGT), partnering with pharmaceutical and biotechnology companies to navigate the unique challenges of advanced therapies. We support the entire development process, from preclinical planning through clinical trial execution, regulatory approval, and post-marketing activities. With decades of experience in rare and complex diseases, CTI has led hundreds of CGT trials across a wide range of therapeutic areas. Our dedicated CGT teams bring specialized scientific, clinical, and regulatory expertise to accelerate timelines, reduce risk, and streamline global operations. In addition to CRO services, CTI offers an integrated clinical research site and full-service global central and specialty laboratories, enabling seamless data collection and analysis for advanced therapies. CTI operates in more than 60 countries across six continents, with global headquarters in the Greater Cincinnati area.
With a rich heritage dating back hundreds of years, Cytiva brings a wealth of technical expertise and talent, a broad and deep portfolio, and exceptional service help researchers and biopharma advance therapeutics at every stage from discovery to delivery. We supply the tools and support our customers need to work better, faster, and safer, leading to the delivery of transformative medicines to patients. Our combined portfolio includes well-recognized names such as Allegro™, Supor™, iCELLis™, and Kleenpak™, in addition to ÄKTA™, Amersham™, Biacore™, FlexFactory™, HyClone™, MabSelect™, Sefia™, Whatman™, and Xcellerex™.
Dark Horse Consulting Group (DHCG) is a fully-integrated global consulting practice offering services across biopharma markets with a focus on CGT. Comprising two business units, Dark Horse Consulting (DHC) and BioTechLogic (BTL), we offer a broad scope of expertise, resources, and engagement types that uniquely positions us to serve a wide range of client types and address an extensive scope of challenges throughout full product and organizational lifecycle. Together, we apply best practices across industries to address the varied needs of our clients, who range from biopharma companies to tools/tech providers to VC/PE investors. DHC offers unmatched CGT expertise designed to close clients’ knowledge and expertise gaps, thus enabling them to accelerate their strategic objectives across CMC, regulatory, nonclinical, clinical, quality/compliance, and business analytics. BTL offers operational, execution-level experience and expertise to help clients bring products to market quickly and successfully with offerings in CMC, regulatory, and quality/compliance. Our joint cross-functional/cross-organizational teams are customized to meet the specific needs of our clients on a case-by-case basis.
www.darkhorseconsultinggroup.com | www.biotechlogic.com
Discovery Oasis, a biotechnology innovation hub located adjacent to the Mayo Clinic Phoenix Hospital, 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 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.
Discovery Square is a dynamic, 16-block innovation district in downtown Rochester, developed through the Destination Medical Center (DMC) initiative—a $5.6 billion, 20-year public-private investment plan anchored by Mayo Clinic. Located just 495 steps from the doors of Mayo Clinic’s headquarters, it serves as an urban life-science hub. The district includes One and Two Discovery Square, which opened in 2019 and 2021 respectively, offering cutting-edge lab and office space designed to foster collaboration among Mayo Clinic, startups, researchers, and industry leaders. One Discovery Square is home to tenants from key innovation initiatives at Mayo Clinic, leading industry partners, start-ups, and higher education—creating an environment where collaboration and discovery thrive. Two Discovery Square, Rochester’s first WiredScore-Certified building, features advanced digital infrastructure, flexible lab configurations, imaging support, AI capabilities, and communal spaces that promote innovation. Looking ahead, in 2026 Discovery Square will open two shared lab spaces to support Rochester’s growing start-up economy.
Founded in 2015, Dot Compliance provides a ready-to-deploy, Salesforce-native eQMS with the industry’s first AI specifically built to deliver safe, reliable decision guidance for critical quality issues. This offers faster, more proactive quality and compliance through vertical AI that empowers data-driven decision making in life sciences quality and compliance. The company’s solutions are trusted by life sciences companies, both large and small, worldwide. Dot Compliance is certified with ISO/IEC 42001:2023, ISO 9001:2015, ISO 27001:2022 and ISO 27017:2015. All solutions are fully compliant with 21 CFR Part 11, 21 CFR Part 820, EU Annex 11 and support ISO 13485 and ISO 14971.
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
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
EQUASHIELD® is a global leader in healthcare technology, driven by a commitment to innovation, safety, and efficiency. Renowned for its flagship Closed System Transfer Device (CSTD), which has set the benchmark for protecting healthcare workers and patients during hazardous drug compounding and administration, EQUASHIELD® continues to pioneer transformative solutions. Building on its legacy, the company has expanded into automation to streamline workflows and enhance operational safety. With the development of CellSHIELD®, EQUASHIELD® is advancing cell and gene therapy manufacturing, offering cutting-edge solutions that address critical industry challenges and delivering technologies that empower professionals and improve patient outcomes.
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.
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
Forge Biologics, a member of Ajinomoto Bio-Pharma Services, is a gene therapy contract development and manufacturing organization (CDMO) enabling access to life-changing gene therapies by bringing them from concept to reality. Forge’s 200,000 square foot facility, the Hearth, is headquartered in Columbus, Ohio, and houses 20 custom-designed cGMP suites with 20,000L of bioreactor capacity. Forge’s end-to-end, scalable plasmid and AAV manufacturing services include research-grade manufacturing, process and analytical development, cGMP manufacturing, fill and finish, and integrated regulatory support to help accelerate the timelines of transformative medicines for patients with genetic diseases.
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.
Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development solutions to the life sciences industry. We collaborate with emerging and large biopharmaceutical, biotechnology, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients. Fortrea provides phase I-IV clinical trial management, clinical pharmacology and consulting services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team working in about 100 countries is scaled to deliver focused and agile solutions to customers globally. Follow us on LinkedIn and X (formerly Twitter).
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
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
FUJIFILM Biotechnologies, a subsidiary of FUJIFILM Corporation, is a world-leading contract development and manufacturing organization (CDMO) for biologics, vaccines and advanced therapies. With over 30 years of experience, the Company specializes in developing and manufacturing biopharmaceuticals using microbial, mammalian, and host/virus systems. With over 4,800 employees, FUJIFILM Biotechnologies operates a fully integrated, kojoXTM global network with major facilities in the United States, the United Kingdom, and Denmark, with a planned new site in Holly Springs, North Carolina, USA. The Company’s kojoXTM manufacturing network ensures supply chain agility for its customers through modular facilities and standardized processes for seamless scaling and technology transfers. FUJIFILM Biotechnologies offers comprehensive services, ranging from proprietary cell line development, to process and analytical development, and through to clinical and commercial manufacturing.
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.
Genezen is a best-in-class gene therapy CDMO with over a decade of experience supporting the cell and gene therapy manufacturing market worldwide. With capabilities across vector-modalities (AAV, lentiviral, retroviral, and others), Genezen partners with innovator organizations to deliver potentially life-saving gene and cell therapies – from concept to commercial. With flexible and customer-centric programs, Genezen tailors its partnership-model approach to all sizes and stages of organizations, to make viral vector production accessible to both early-stage, growth-oriented companies and established industry leaders. Genezen’s state-of-the art Lexington, MA site holds multiple global regulatory licenses, including with the FDA, EMA, Health Canada, and MFDS Korea, in support of the active manufacture of a commercial viral vector-based product. Our Indianapolis, IN site provides cGMP manufacturing for viral vectors and is currently supporting a program entering a pivotal clinical trial.
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.
Guidehouse is a leading global consultancy with a significant footprint in healthcare, serving both public and commercial sectors. Our specialized Cell & Gene Therapies practice has successfully guided over 25 companies and 50+ assets, including launch of 8 marketed therapies. We create tailored solutions for Cell & Gene Therapies, encompassing evidence generation plans, alternative payment models, and comprehensive pricing & reimbursement strategies that support the unique value and drive sustainable access for these innovative therapies.
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.
InspiroGene™ by McKesson specializes in advancing the commercialization of cell and gene therapies (CGT). InspiroGene is more than a partner—we’re an ally that collaborates with you to bridge the gap between innovation and reality. Our suite of integrated and scalable solutions is designed to meet both your current and future needs, unlocking the full potential of your CGT. With InspiroGene by your side, manufacturers and providers can be confident that patient access to CGT treatment is optimized and streamlined, with seamless integration from the warehouse to treatment center. Our distribution assets, cold chain storage and logistics solutions and innovative technology platforms empower stakeholders to manage, monitor, and deliver life-changing care faster and more efficiently. InspiroCare, our CGT-dedicated patient hub, is designed to provide personalized, compassionate support, ensuring that patients and their caregivers receive the guidance and resources they need. Our specialty pharmacy capability reduces product transit times and helps ensure timely and reliable delivery to treatment centers, all designed to help providers and patients access to life-changing therapies. InspiroGene is backed by over a decade of McKesson’s real-world CGT expertise and is committed to stakeholder collaborations that transform the care patients receive on their path to better health.
Because their lives are in our hands…
Depend on us to get it right.
Integrated DNA Technologies (IDT), a Danaher company, accelerates genomic medicine from discovery to clinic. With over 35 years of trusted expertise, we deliver quality solutions that accelerate discoveries—from pioneering oligonucleotide synthesis to end-to-end CRISPR workflows. Our cGMP Oligonucleotide Manufacturing Facility produces engineering-grade and cGMP guide RNA under ICH Q7. Through our partnership with Aldevron, we provide cGMP-grade Cas nucleases, along with off-target analysis services and regulatory guidance to support IND submissions.
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.
The Japanese Society for Regenerative Medicine (JSRM) is the largest academic society in regenerative medicine globally, with over 6,000 members spanning diverse fields, including basic and clinical sciences, tissue engineering, bioethics, regulatory science, and health policy. JSRM serves as a multidisciplinary platform for researchers, clinicians, industry leaders, and policymakers to collaborate on regenerative medicine development and implementation. The society actively engages in policy advocacy, develops industry standards, and hosts international academic conferences to drive scientific and regulatory advancements in regenerative medicine.
Kenai Therapeutics is a clinical-stage biotechnology company pioneering next generation approaches to cure neurological conditions. By leveraging a proprietary, Nobel Prize-winning iPSC platform, Kenai is developing off-the-shelf, allogeneic neuron replacement and gene-modified cell therapies designed to be disease-modifying rather than symptom-masking. Kenai’s lead candidate, RNDP-001, is in development for the treatment of moderate to moderate-severe forms of idiopathic Parkinson’s disease. The company’s additional programs target inherited and genetically driven subtypes of Parkinson’s disease and other neurological conditions, with the goal of delivering long-lasting restoration of function. Kenai’s exclusive manufacturing partnership with FUJIFILM Cellular Dynamics, Inc., enables scalable, cryopreserved production of high-potency cell therapies. Founded in 2022, Kenai is backed by leading life science investors and is headquartered in San Diego, CA.
Kincell Bio partners with innovators to deliver cell therapies for patients. With manufacturing facilities located in Research Triangle Park, NC, and Gainesville, FL, Kincell Bio is a contract development and manufacturing organization (CDMO) with the mission to streamline CMC development, apply expertise in analytical and process development, and facilitate quality-first, reliable GMP supply from early clinical through pivotal studies and product launch—ensuring rapid timelines without compromising on quality.. Kincell Bio is focused on supporting innovative companies developing immune cell therapies, including autologous and allogeneic CAR-T, CAR-NK, and CAR-M programs, as well as developing expertise in stem cell products and iPSCs.
Knowledge Palette is a privately held discovery stage Japanese startup span off from RIKEN Institute, focusing on drug development in the field of CNS utilizing our powerful single cell and mega throughput bulk transcriptome technology in combination with AI. Using this powerful platform technology, we offer fee-for-service on “identification of Critical Quality Attribute (CQA)” and “cell culture medium ingredients optimization from millions of combinations” to regenerative medicine and cell therapy companies.
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.
Landmark Bio translates groundbreaking research into life-changing medicines. We provide development, manufacturing, and regulatory capabilities to help early-stage life science innovators rapidly progress advanced therapies from bench to clinic. Launched in 2021, Landmark Bio is an unprecedented venture bringing together the best of industry, academia and research hospitals to accelerate life sciences innovation. A public benefit company, our work advances emerging technologies, demonstrates therapeutic potential, and improves human health. Landmark Bio is based in Watertown, Mass. Our founders include Harvard University, Massachusetts Institute of Technology, FUJIFILM Diosynth Biotechnologies, Cytiva and Alexandria Real Estate Equities, Inc. Collaborating partners include Massachusetts General Hospital, Brigham and Women’s Hospital, Beth Israel Deaconess Medical Center, Dana-Farber Cancer Institute and Boston Children’s Hospital.
Lonza is one of the world’s largest contract development and manufacturing organizations (CDMOs) dedicated to serving the healthcare industry. Working across five continents, our global team of around 18,500 colleagues works alongside pharma and biotech companies to turn their breakthrough innovations into viable therapies.
Machaon Diagnostics is a specialty laboratory helping clinical trials stay on track by providing fast testing. Our expertise in complement and immunology help you prepare for serious adverse events (SAEs) in your trials.
We support sponsors of cell and gene therapy trials by quickly testing for safety or biomarkers. Tests available with a turnaround time of <24 hours include:
Our speed sets us apart. We also offer sponsored testing and data sharing services. Machaon’s proprietary, real-time lab data identifies rare patients and samples within hematology, nephrology, and immunology indications. Samples come to us from all 50 US states and many countries worldwide.
For 22 years, Machaon has been a leader in serving medical centers, CROs, and biotech/pharmaceutical companies. Let us help you meet trial milestones while ensuring patient safety. Contact us to get input on your RFPs and study design.
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.
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
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
Minaris Advanced Therapies is a global contract development and manufacturing organization (CDMO) and contract testing provider focused exclusively on cell and gene therapies. Minaris Advanced Therapies is headquartered in Philadelphia, Pennsylvania, and has more than 650,000 square feet of infrastructure across the United States, Europe, and Asia. We have manufactured and released over 7,500 GMP batches and our global network supports therapy developers through early-stage development, clinical trials, and commercial manufacturing. By combining scientific expertise with best-in-class manufacturing and testing services, we help bring safe, effective therapies to patients faster and more efficiently.
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.
Moffitt Cancer Center is a renowned National Cancer Institute-designated Comprehensive Cancer Center based in Tampa, Florida. It is dedicated to the prevention and cure of cancer through research, education and patient care. Its unique ecosystem integrates preclinical development, translational research, and clinical care in collaboration with world-renowned scientific experts and leaders in the field of Cell and Gene Therapy. As part of this ecosystem, Moffitt’s onsite Cell Therapy and Gene Engineering facility provides GMP manufacturing of cell therapies and viral vectors for clinical trials, supporting both Moffitt faculty and industry partners. With over 15 years of expertise of translating cell therapy assets into the clinic, Moffitt has manufactured and supported over 50 INDs. Moffitt’s cell manufacturing expertise includes TILs, CAR-Ts (alpha beta & gamma delta), TCR-T, Tregs, and DC vaccines.
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
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
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.
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.
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.
OXB, previously Oxford Biomedica, is a global quality and innovation-led CDMO in cell and gene therapy with a mission to enable its clients to deliver life changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, OXB has 30 years of experience in viral vectors; the driving force behind the majority of cell and gene therapies. OXB collaborates with some of the world’s most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV), adenovirus and other viral vector types. OXB’s world-class capabilities span from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods and depth of regulatory expertise. To discuss your viral vector needs email partnering@oxb.com.
Parexel is a global clinical research organization (CRO) with a focus on community, providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. We advance cell and gene therapy trials by focusing on empirical data, lived experience, and pragmatic innovation to accelerate clinical development. With comprehensive insights from former regulators and experienced operational delivery units from around the world, we help sponsors navigate new and evolving regulatory and manufacturing challenges, operational complexities, and obstacles to market and patient access. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 clinical research professionals works in partnership with biopharmaceutical leaders, emerging innovators and study sites to design and deliver cutting edge clinical trials that differentiate in time and space. We believe that increasing access and participation to advanced therapy clinical studies should be a care option for anyone, anywhere. Our industry knowledge and record of 40 years of developing novel therapies gives us the opportunity to proactively address healthcare’s most complex diseases, while our innovation efforts offer data-driven solutions to make each phase of the clinical trial process more efficient while decreasing sponsor spend. Parexel works With HeartTM so that every trial can make a difference. This approach continues to work for us, with Parexel being the recipient of the 2024 and 2023 Society for Clinical Research Sites (SCRS) Eagle Award for advancing the clinical research profession through strong site partnerships and named “Top CRO to Work With” by investigative sites worldwide in the 2023 WCG CenterWatch Global Site Relationship Benchmark Survey.
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.
We take the research and development of Advanced Therapies beyond the boundaries of a traditional Contract Research Organization (CRO). Specializing in the qualification and validation of potency assays and other Quality Controls for Advanced Therapy Medical Products (ATMPs), ensuring compliance with the most stringent regulations. Our commitment to excellence at every stage of development and our expertise in Regulatory Affairs make us your ideal partner to successfully bring your product to market.
QuTEM is a global leader in GMP-certified transmission electron microscopy (TEM) services and nanoparticle quality control for the pharmaceutical industry. Specializing in regulated environments, QuTEM addresses the challenge of converting TEM images of vaccines and gene therapy vectors into quantifiable data linked to biological activities. Using its proprietary GMP-compliant software, Gridsee, QuTEM strongly focus on characterizing vectors such as AAV, AdV, LVV, VSV, EV, MVA, phages, liposomes, and LNPs, and plays a crucial role in advancing the development of next-generation treatments by providing reliable and traceable data on critical quality attributes.
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.
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.
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.
Sartorius is a global leader in life sciences research and biopharmaceuticals, offering innovative solutions for cell and gene therapy. From concept to clinic, Sartorius supports every stage of development, from discovery to commercial manufacturing. Our comprehensive portfolio accelerates time-to-market and optimizes costs. Through the Lab Products & Services Division, we provide laboratories with advanced instruments and consumables to streamline workflows and overcome bottlenecks. Our next-generation platforms for cell and protein analysis offer translational insights, bridging the gap from bench to bedside. By enabling automation and rapid in vitro cell-based assays, Sartorius reduces variability across cells, donors, and workflows, ensuring consistency and quality in research and manufacturing. Committed to advancing cell and gene therapy, Sartorius serves pharmaceutical and biopharmaceutical companies, as well as academic research institutes, driving innovation and excellence in the field.
ScaleReady provides the field of cell and gene-modified cell therapy (CGT) with a G-Rex centric manufacturing platform that enables the world’s most practical, flexible, scalable, and affordable CGT drug product development and manufacturing. The G-Rex manufacturing platform is currently used by a rapidly growing list of over 800 organizations and is producing drug products for approximately 50% of CGT clinical trials as well as 5 commercially approved CGT drugs. CGT entities relying on the breadth and scope of ScaleReady’s expertise can expect to save years of time and millions of dollars on the path to CGT commercialization. For more information about the ScaleReady G-Rex® Grant Program, please contact info@scaleready.com.
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.
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.
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. We support a diverse, equitable and inclusive culture. To learn more about how we are Shortening the distance from lab to life®, visit syneoshealth.com.
More than 50 years of experience have made Technoflex, Worldwide leader in design and manufacture of flexible bags with associated connectors for the pharmaceutical industry. Our cutting-edge technology and internal R&D resources enable us to provide all-inclusive innovative solutions, reliable and easy-to-use. By working well upstream of its customers’ requirements and by anticipating the technical, environmental and regulatory changes, Technoflex optimize the design of the future generations of flexible bags and associated connectors. Our proficiency of the manufacturing process in clean room ISO 7 (Class 10000) allows us to provide innovative containers with a low AQL (no leaks, no particles). The different ranges of bags, Inerta®, Dual-Mix®, ReadyMix®, Clarima®, Biocell®, Cryocell®, SafeCell®, Cellflex®, developed by Technoflex are designed for various application such as: IV therapies, Compounding, Nutrition, Cell therapies, Biotherapies, Bioprocessing. All our bags are compliant with the European and American pharmacopoeias (FDA: DMF #19057) and provide customizable options on demand.
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 early-stage research through process development and clinical manufacturing. To meet the special demands of emerging therapies, our ISO 13485 certified production facilities were built with flexibility in mind, allowing us to quickly adapt our manufacturing setup to satisfy unique requests. With almost 30 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.
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
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.
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
Touchlight is an innovation-driven leading CDMO pioneering enzymatic GMP DNA production to enable the genetic medicine revolution. As pioneers with an FDA Drug Master Filing accepted in 2022 followed in 2025 with the world’s first GMP license, Touchlight’s enzymatic DNA technology is on the cutting edge of AAV, mRNA, DNA vaccine, and gene editing innovation. With multiple client products already in the clinic, Touchlight’s evidence-based, synthetic DNA manufacturing solutions offer a scalable, sustainable alternative to plasmid DNA (pDNA) for all stages of pre-clinical, clinical and commercial development. The company and technology are built on the conviction that DNA is fundamental to the future of medicine. Traditional methods, based on bacterial fermentation, are slow, costly, and unable to meet the growing demands of genetic medicine due to limited scalability and speed. Founded in 2007, Touchlight’s team is inspired by breakthroughs in genetic medicine, recognizing the urgent need for innovative DNA production techniques to support the future of genetic therapies.
TrakCel is the market-leading provider of Cell Orchestration Solutions. Our flagship product, OCELLOS, support more than 20 cell therapies, including 5 commercial therapies, with 3,000+ trained users across 350+ clinics. OCELLOS supports cell therapies at all clinical and commercial stages by:
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.
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
Wacker Biotech is the global biologics CDMO partner for advanced nucleic acid-based therapies. We cover the full manufacturing chain, from plasmid DNA (pDNA) to the IVT of RNA to lipid nanoparticle (LNP) formulation. Via our proprietary PLASMITEC® platform, we also produce high-quality (>90% supercoiled) plasmids for DNA vaccines and viral vector gene and cell therapies. In addition to science-driven solutions, we provide guidance from concept to commercialization and flexibly serve customer needs ranging from R&D quality and scale to GMP manufacturing for clinical and commercial supply. Our five sites in Germany, the Netherlands and USA include a state-of-the-art mRNA competence center in Halle, Germany and a pDNA center of excellence in San Diego, California, USA. Complementing these sites is a dedicated R&D center in Munich, Germany with scientific experts leading groundbreaking nucleic acid research, technology innovations and collaborations. Wacker Biotech is wholly owned by Munich-based Wacker Chemie AG, a publicly traded company founded in 1914 that pioneered some of the 20th century’s leading biochemistry advances. We have 30+ years of experience developing biologics to advance human and animal health.
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
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 110+ dedicated presentations by the leading publicly traded and privately held companies in the space. Attracting over 1,500 attendees – over 30% 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.
