Sponsors

Sartorius CellGenix is a leading global supplier of high quality raw materials for the expanding cell and gene therapy market. We develop, manufacture and market preclinical and GMP cytokines along with GMP serum-free media for further manufacturing of ATMPs. Our products are used by academia and industry partners in preclinical development, clinical trials, and commercial manufacturing throughout the world. With +25 years of experience, we are experts in the GMP manufacturing of raw materials for the cell and gene therapy space. By offering expert technical and regulatory support we can help simplify raw material qualification and validation efforts. www.cellgenix.com

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

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

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

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

Since 2013, Precision’s interdisciplinary teams have been advancing clinical, manufacturing and commercialization solutions to help innovators transform patient lives. We know that delivering a cell or gene therapy to market requires a nuanced, comprehensive and integrated approach, scientific and manufacturing expertise, and the right partner. That’s precisely why we’ve launched Precision ADVANCE, a collection of interconnected services and complementary teams uniquely focus on the complexities of clinical, regulatory, manufacturing, and commercial needs to successfully bring cell or gene therapies to market. Learn more about how we accelerate clinical development with Precision for Medicine, optimize next-gen manufacturing with Project Farma and drive commercial success with Precision Value & Health. www.precisionmedicinegrp.com

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, and Gibco brands, we offer an unmatched combination of innovative technologies, manufacturing, and distribution capabilities. www.thermofisher.com/cellandgenetherapy

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 a US-based, full spectrum Gene Therapy partner. The company was born out of Nationwide Children’s Hospital where Zolgensma, the first FDA approved Gene Therapy for SMA, was initially developed. We have supported over 60 IND’s for viral vector-based gene therapy products around the world and have more than 15 years of experience in small to large scale GMP viral vector manufacturing. Andelyn Biosciences provides clients with a broad range of viral vector manufacturing platforms and solutions, including adherent and suspension systems. We support our clients throughout every step of cGMP manufacturing – from pre-clinical trials of gene-modified products and cell therapies to commercial production. We also offer plasmid manufacturing services and vector development, using QbD, DoEs and process characterization to establish and improve our viral vector manufacturing processes. www.andelynbio.com

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.

www.armiusa.org/connect

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

From Discovery to Delivery™, Azzur Group provides the life science community full life-cycle solutions for all their GxP needs.  From Azzur Cleanrooms on Demand™ facilities, to our labs, training centers, and consulting offices across the nation, Azzur Group helps organizations start, scale, and sustain their growing enterprises. With nearly four decades of service to the life science community, we have become a trusted partner to the world’s leading pharmaceutical, biotechnology, medical device, and healthcare companies, as well as their supply chain. www.azzur.com

BioCentriq is a full service CDMO for cell and gene therapy process development and clinical manufacturing. Our ISO-7 certified GMP clinical manufacturing facility is in Newark, NJ. We manufacture autologous and allogeneic cell therapies, gene therapies and provide analytical and quality services across several cell types. We offer viral vector production, cell and viral banking and upstream and downstream processing. Additionally, we have the capabilities to manufacture immunotherapies, including monoclonal antibodies and proteins, and vaccines. We allow customer access to work in hybrid teams from tech transfer through GMP clinical production. BioCentriq also has a BSL-2 certified process development facility located in South Brunswick, NJ to accelerate scale-up and translation activities. We offer pre-defined and custom workforce development programs as well as full access to our centers during projects in a unique collaborative approach with our expert scientists to ensure knowledge transfer. www.biocentriq.com

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

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.

www.cardinalhealth.com/cellandgene

Cell One Partners helps cell and gene therapy companies advance quickly and efficiently towards commercialization. We offer a hands-on client team and network of strategic advisors and industry insiders with unparalleled depth of experience. This unique combination of scientific and commercial expertise guides your groundbreaking scientific research from the laboratory to the clinic to commercialization. We support all aspects of the commercialization pathway including: Clinical development plan | Product pipeline assessment | Manufacturing strategy and relationships | Management and organization | Communications program development and execution | Regulatory and approval pathway development www.cellonepartners.com

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

Center for Breakthrough Medicines (CBM) is an innovative cell and gene therapy focused contract development and manufacturing organization located in the heart of “Cellicon Valley” in Greater Philadelphia. CBM’s integrated and comprehensive service offering provides a one-source solution to accelerate speed to market for advanced therapies. A client-driven approach coupled with a patient-centric culture delivers high quality and reliable process and analytical development, viral vector manufacturing, GMP testing, cell processing, plasmid production, and cell banking services to support the full product life cycle. Through our relationship with Discovery Labs, CBM is able to access extensive expansion capacity. Currently CBM occupies 700,000 ft2 with an additional 1,000,000 ft2 plus that can be rapidly retrofitted for clinical and commercial manufacturing allowing clients flexibility in their CMC approach as their pipeline grows and products progress to commercialization. www.breakthroughmedicines.com

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

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

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

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

MilliporeSigma, a leader in life science, is a business of Merck KGaA, Darmstadt, Germany.  Science is at the heart of everything we do – it drives the discoveries we make and the technologies we create.  Our products and services help you safely and efficiently develop and manufacture cell and gene therapies.  Our 30+ years of global expertise integrating leading manufacturing technologies with process development, scale-up, analytical development and biosafety testing is here to help you accelerate your path to curses.  Draw on our experience to bring your cell and gene therapies to life.

www.emdmillipore.com

www.emdmillipore.com/fastforward

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

Syneos Health® (Nasdaq:SYNH) is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, strategically blending clinical development, medical affairs and commercial capabilities to address modern market realities. We bring together more than 29,000 minds, across more than 110 countries, with a deep understanding of patient and physician behaviors and market dynamics. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. Syneos Health supports a diverse, equitable and inclusive culture that cares for colleagues, customers, patients, communities and the environment. To learn more about how we are Shortening the distance from lab to life®, subscribe to our podcast.

www.syneoshealth.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

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

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 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

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

Akron’s strategic focus is supplying and contract manufacturing GMP-compliant ancillary materials to enable the advancement of cell and gene therapies. Since 2006 Akron has supplied the cell and gene therapy market with the highest quality cytokines and growth factors, blood-derived products, media, transfection reagents, and other custom development services. Akron is an ISO 13485-certified company operating in line with cGMP guidelines and international standards. In April of 2022, Akron opened its second 110,000 sq. ft. GMP facility for the production of gene editing technologies and plasmid DNA. The facility is FDA 21 CFR Part 11 and Eudralex Vol 4 Annex 11 compliant to support the manufacture of high-quality ancillary materials and drug substances. Akron provides advanced therapy developers the scale, compliance, flexibility, and regulatory support to develop novel technologies from pre-clinical through to commercialization. www.akronbiotech.com

Albumedix is a science-driven company and recognized leader of best-in-class albumin-enabled solutions. Established in the UK in 1984, with a mission to empower excellence, Albumedix has supported its life-science partners to deliver hundreds of million safe doses of clinical and marketed therapeutics, globally. Albumedix’ solutions include the world’s only USP-NF compliant recombinant human albumin (Recombumin®), client-centric development and compliance services and drug-enhancing technologies (Veltis®). Recombumin® albumins have use throughout the entire cell therapy development process, including improving culture, expansion, cell isolation, formulation, and cryopreservation. The effect is incredibly pronounced in high stress environments such as freeze and thaw as well as improving viral vector stability. By always striving for more and collaboratively challenging status quo, Albumedix enables the development and commercialisation of advanced therapies and next-generation biopharmaceuticals to the benefit of people worldwide. www.albumedix.com

Azenta Life Sciences provides unrivaled sample exploration and management solutions to help our customers accelerate discovery, development, and delivery to bring impactful breakthroughs and therapies to market faster. We are the global leader in automated compound management for drug discovery, biological storage, and sample processing solutions. Azenta understands the importance of sample integrity and provides a comprehensive range of solutions across our leading capabilities of genomic services, sample repository services (SRS), consumables and instruments, data management and informatics, sample sourcing, and automated ultra-cold storage. www.web.azenta.com

Bio-Techne unites the brands of R&D Systems, Novus Biologicals, Tocris Bioscience, and ProteinSimple to deliver an array of GMP-grade products and services for immune cell, stem cell, and gene therapies. GMP Reagents – We manufacture GMP cytokines, growth factors, and small molecules for use as ancillary materials. Our new state-of-the-art GMP manufacturing facility accommodates the increasing demands of cell therapy production. Cell Manufacturing – We focus on cell manufacturing needs with GMP Cloudz™ cell activation kits, ExCellerate™ xeno-free cell culture media, and GMP ProDots™ Proteins that enable direct welding into closed system manufacturing processes. Custom Services – Our TcBuster™ technology streamlines complex genome editing projects to rapidly advance your cell manufacturing program. We also offer GMP CDMO services and custom reagent and immunoassay development. Cell and Protein Analysis – Our industry-leading expertise in immunoassay development enables you to rigorously monitor your cells and their secretory profiles with automated ProteinSimple™ instruments and Luminex® assays. www.bio-techne.com

For over 30 years, Bionique Testing Laboratories has been a trusted partner and global leader of Mycoplasma Testing Services for the life science industry. We provide a comprehensive service offering ranging from relevant compendia to a GMP compliant Real-Time PCR assay to support the development and manufacturing of cell gene therapies from proof on pre-clinical through clinical trials to commercialization. Our capabilities extend to development and validation of Rapid Microbial Methods to meet the 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

Ecolab provides comprehensive contamination control strategies and solutions for any stage of cell and gene therapy product development. We provide key regulatory insights, Bioquell bio-decontamination solutions, cleaning and disinfection tools, isolators and a programmatic approach that will help you in reducing your risk of contamination. Our offerings and expert approach allow for scalable solutions that can be implemented easily as you progress all the way through to manufacturing. A trusted partner at nearly three million customer locations, Ecolab is the global leader in water, hygiene and infection prevention solutions and services. With annual sales of $12 billion and more than 50,000 associates, Ecolab delivers comprehensive solutions, data-driven insights and personalized service to advance food safety, maintain clean and safe environments, optimize water and energy use, and improve operational efficiencies and sustainability for customers in the food, healthcare, hospitality, Life Sciences and industrial markets in more than 170 countries around the world. www.bioquell.com

CCRM, a Canadian not-for-profit organization funded 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 aims to accelerate 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 Advanced Therapeutic Cell Technologies, and a GMP facility within a 40,000 square foot office designed for advanced cell manufacturing. CCRM is the commercialization partner of the Ontario Institute for Regenerative Medicine and the University of Toronto’s Medicine by Design. CCRM is hosted by the University of Toronto and was launched in Toronto’s Discovery District on June 14, 2011. www.ccrm.ca

Cryoport Systems is the premier provider of temperature-controlled supply chain solutions for the life sciences industry. We proudly offer the most comprehensive solutions to support research, clinical trials and commercial therapies around the world. From master cell storage, cell collection, cryopreservation, packaging/ labeling, kit production and QP services to distributing the life-saving therapy to the patient, Cryoport Systems is able to meet all R&D, clinical, manufacturing, operations and quality needs. Our Integrated Supply Chain Platform brings complete integration and transparency to every step of the journey – delivering certainty to the life sciences. www.cryoport.com

Curate Biosciences (formerly GPB Scientific, Inc.) enables cell processing that radically changes the outcomes and economics of cell therapy manufacturing. The Curate® Cell Processing System applies Deterministic Cell Separation™ (DCS) technology through a benchtop system and single-use cassettes optimized for T cell isolation. With virtually no cell loss, and designed for both manufacturing and clinical application, the Curate System enables production of CAR-T and other cell therapies beyond today’s limitations. The Curate System is an easy to use, functionally closed wash, separation, and concentration device designed primarily for integration within the cell therapy workflow, processing standard leukopaks within approximately 40 minutes. The system’s core DCS technology is uniquely gentle on cells, circumvents the need for cell labeling or Ficoll processing for WBC isolation, and enables substantially better recovery (>2-fold vs Ficoll-based commercial methods) and purity (99% Platelet and 92% RBC removal).

www.curatebio.com

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

Excellos is a full-service CDMO that pairs the collection of human cells and tissues with manufacturing and development services to drive innovation in the cell and gene therapy industry. We supply cGMP cellular products and services and process development and manufacturing expertise to cell and gene therapy clients. Our relationship with the San Diego Blood Bank provides exclusive access to a large and diverse donor pool and public cord blood bank. Excellos has research and development capabilities to isolate and characterize human cell and tissue samples with the highest quality, setting a new standard across the industry. Excellos functions on a global scale, focusing on therapies in preclinical through phase II/III with a clear scale-up pathway to support commercial level operations. Our mission is to facilitate the advancement of cellular therapies to help fully realize the potential of these powerful therapeutics, saving lives today and improving life tomorrow. 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.

www.formbio.com

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)

www.fujifilmdiosynth.com

G-CON Manufacturing designs, builds and installs prefabricated cleanrooms. G-CON’s POD portfolio provides cleanrooms in a number of dimensions for a variety of uses, from laboratory environments to personalized medicine and production process platforms. G-CON POD cleanrooms surpass traditional cleanroom structures in scalability, mobility and the possibility of repurposing once the production process reaches its lifecycle end. www.gconbio.com

Founded in Indianapolis in 2014, Genezen offers early-phase process development, GMP vector production, and analytical testing services, building on the company’s expansive knowledge and experience in the industry and working with the nation’s leading institutions. Genezen Laboratories is focused on supporting the demands of the current and future gene and cell therapy manufacturing market worldwide— making viral vector production accessible to both early-stage, growth-oriented companies and established industry leaders. For more information, or to learn more about services offered in Genezen’s new cGMP facility and cutting edge lentiviral vector platforms, please visit: www.genezen.com

Horizon Discovery Group plc, a PerkinElmer company (“Horizon”) drives the application of gene editing and gene modulation to support scientists on the path from research to therapy. Horizon’s tools and services are used by many of the world’s foremost academic institutes, global pharmaceutical and biotechnology companies, as well as clinical diagnostic laboratories, to gain a greater understanding of gene function, identify genetic drivers behind human disease, develop and validate diagnostic workflows, and deliver biotherapeutics, cellular and gene therapies for precision medicine. With more than a decade of experience in the engineering of cell lines, Horizon offers an unmatched portfolio of innovative solutions based upon the ability to modulate, or permanently alter, the function of almost any gene in human and other mammalian cell lines. Horizon is headquartered in Cambridge, UK with offices in USA and Japan. www.horizondiscovery.com

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

Koerber Pharma Software, formerly Werum IT Solutions is the world’s leading supplier of manufacturing execution systems (MES) and manufacturing IT solutions for the pharmaceutical and biopharmaceutical industries. Our out-of-the-box PAS-X software is run by the majority of the worlds to 30 pharmaceutical and biotech companies and by many mid-sized manufacturers. Our software product Werum PAS-X MES is recognized as the world’s leading Manufacturing Execution System (MES) for the pharma, biotech and cell & gene therapy industries. We offer a full-scope MES solution comprising the PAS-X software product and pre-configured content for pharmaceutical, biotech and cell & gene processes completed by consulting, training and support services. PAS-X is a mature standard software product with full functionality that can be implemented within a comparably short time. Körber is an international technology group with about 10,000 employees, more than 100 locations worldwide and a common goal: We turn entrepreneurial thinking into customer success and shape the technological change. At the Körber Business Area Pharma we are delivering the difference along the pharma value chain with our unique portfolio of integrated solutions. www.koerber-pharma.com

Marken is a wholly owned subsidiary of UPS and is a critical part of UPS Healthcare. With Polar Speed and Marken included, the UPS Healthcare division staffs 128 locations with 5,500 employees worldwide. Marken offers a state-of-the-art GMP-compliant depot network and logistic hubs for clinical drug product storage and distribution in 59 locations worldwide, while maintaining the leading position for Direct-to-Patient and Home Healthcare services, biological sample shipments and biological kit production. Marken’s dedicated 2,000+ staff members manage 150,000 drug product and biological sample shipments every month at all temperature ranges in more than 220 countries and territories and have orchestrated 14,000+ home healthcare visits. Additional services such as cell and gene supply chain services, ancillary material sourcing, storage and distribution, shipment lane verification and qualifications, as well as GDP, regulatory and compliance consultancy add to Marken’s unique position in the pharma and logistics industry. Moving Our World Forward by Delivering What Matters. www.marken.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. www.maxcyte.com

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

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.

www.recipharm.com

Rentschler ATMP was launched by Rentschler Biopharma in 2021 to provide high-quality viral vectors for advanced therapy medicinal products (ATMP). Rentschler Biopharma is a leading global CDMO, focused exclusively on client projects. Thanks to our 50 years of proven scientific expertise in biotechnology, we count ourselves among the leaders in the industry. From our headquarters in Laupheim, Germany, and our site in Milford, USA, we offer end-to-end solutions including biopharmaceutical process development and cGMP manufacturing. Our Center of Excellence for cell and gene therapy is located in the UK largest cell and gene therapy cluster Stevenage. At Rentschler ATMP, we are dedicated to advancing cell and gene therapy products from development to cGMP manufacturing for our clients and their patients. https://www.rentschler-biopharma.com/services/cell-and-gene-therapy/

RoslinCT is a leading Cell Therapy Contract Development and Manufacturing Organisation (CDMO), enabling you to safely bring your autologous or allogeneic therapy to patients. We operate a fully licensed GMP manufacturing facility and have a proven track record in the delivery of cell-based products. We offer a range of integrated services from technology transfer, process, and assay development through to GMP manufacturing, storage, QP certification, and batch release of cell-based therapies for clinical trials. We also engage with leading cell and gene therapy developers providing a personalised service. At the heart of RoslinCT is a dynamic, highly experienced team that will understand your goals and will partner with you to get your therapy to market efficiently and effectively. We put quality and integrity at the heart of the business to make sure we provide you with the trust that your life-changing therapy is on the right pathway to commercialisation. www.roslinct.com

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

A critical factor facing the industry is choosing technologies and partners that can deliver scale. The challenges inherent in translating early clinical trials to a reproducible and robust process suitable for scalable commercial production are very significant. Each personalized drug product ultimately depends on a sustainable and consistent supply chain with lots of moving parts. Configured to your exact demands, using an industry-standard framework, TrakCel’s comprehensive supply chain platform ensures every resource is managed, monitored, recorded, and is ultimately performed exactly as required. From sample collection through logistics, manufacturing, and final transplantation, with comprehensive chain of custody, chain of identity, and traceability, TrakCel’s proven technology integrates and orchestrates every aspect of your autologous and allogeneic supply chains in a scalable, compliant, and validated technology platform. www.trakcel.com

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

UBC provides integrated, comprehensive clinical, safety, and patient services. Our experts are committed to guiding sponsors through the product lifecycle and making therapies safer and more accessible. We specialize in collaborating with both emerging and leading pharmaceutical companies, with expertise in rare diseases, novel indications, and cell & gene therapies. By powering this expertise and experience with innovative tools, UBC stands out in the generation of real-world evidence of product safety, value, and effectiveness.

www.ubc.com

Versiti is proud to support clinical research and manufacturing through seamlessly integrated clinical trial capabilities, Leukopak and other human blood product provision, and central laboratory services. With over 70 years of industry-leading blood health experience, our depth of expertise in blood collection, laboratory medicine, logistics, and clinical research lend unparalleled support for trial and research partners, every step of the way. www.versiti.org

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has multiple approved medicines that treat the underlying cause of cystic fibrosis (CF) — a rare, life-threatening genetic disease — and has several ongoing clinical and research programs in CF. Beyond CF, Vertex has a robust pipeline of investigational small molecule, cell and genetic therapies in other serious diseases where it has deep insight into causal human biology, including sickle cell disease, beta thalassemia, APOL1-mediated kidney disease, pain, type 1 diabetes, alpha-1 antitrypsin deficiency and Duchenne muscular dystrophy. www.vrtx.com

Wacker Biotech is “YOUR MICROBIAL CDMO FOR ADVANCED THERAPEUTICS” – partner of choice for process development and commercial manufacturing of biopharmaceuticals (therapeutic proteins, vaccines, live microbial products, and plasmid DNA (pDNA)) using microbial hosts. Developed over decades, PLASMITEC®, our plug-and-play platform for pDNA is suitable for manufacturing R&D supplies (non-GMP) up to scale-up to full GMP-compliant production. Wacker Biotech’s integrated service portfolio covers molecular biology, process- and analytical development as well as GMP manufacturing of biologics for clinical and commercial supply. Wacker Biotech maintains four GMP-compliant, FDA- and EMA-certified production plants in Amsterdam (The Netherlands), San Diego (US) and in the German cities of Jena and Halle. Wacker Biotech GmbH, Wacker Biotech B.V. and Wacker Biotech US Inc. are wholly-owned subsidiaries of the Munich-based WACKER Group.

www.wacker.com/biologics

Yposkesi, an SK pharmteco company, is one of Europe’s largest Contract Development and Manufacturing Organizations (CDMO) for gene therapy viral vector manufacturing. A one-stop shop for biotech and pharmaceutical companies seeking to advance clinical trials and commercialize new Advanced Therapy Medicinal Products (ATMPs), Yposkesi offers a full range of services in lentiviral vectors and AAV (Adeno-Associated Virus) cGMP manufacturing. Within its current 50,000 ft2 (approx. 5,000 m2) facility, Yposkesi operates multiple manufacturing suites for bulk drug substance (up to 1,000 L) and fill and finish to support the growing demand for late-phase projects. In 2023, Yposkesi will bring online additional capacity by increasing its global footprint to 100,000 ft2 (approx. 10,000 m2) with a second large-scale facility designed for EMA and FDA compliance. Yposkesi’s investment in innovation ensures that its bioprocessing platforms deliver high quality gene-modified cell therapies and in vivo gene therapy projects. Yposkesi’s staff of ~200 employees is located on the Genopole Campus in Corbeil-Essonnes (South of Paris), France. www.yposkesi.com

ABL is a pure play Contract Development and Manufacturing Organization (CDMO) specialized in the development and manufacturing of virus for vaccine candidates, gene and cancer therapies. ABL’s mission is to provide GMP viral vectors from early-stage to market, contributing to the success of its clients’ immunotherapy innovations. ABL’s CDMO services include bulk drug substance, fill/finish of drug products, process and assay development, and bioanalytical testing. ABL is a subsidiary of the Institut Mérieux. It operates from various locations in Europe and the US. www.abl-biomanufacturing.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

We partner with cell and gene therapy companies to save lives through autologous and allogeneic cellular therapy. We are the only cell and gene therapy solutions provider with customizable services to support the entire end-to-end cell therapy supply chain. As part of the National Marrow Donor Program®/Be The Match®, our organization has sourced, collected and delivered cells from more than 100,000 volunteer allogeneic donors around the world for time-critical cellular therapies. We have extensive experience providing cellular source material consented for research, clinical and commercial use. Throughout the past 30+ years, we’ve developed and continually enhanced our cell collection network and proven cell therapy supply chain infrastructure. Our teams are responsible for more than 6,500 time-sensitive cell therapy shipments per year. Through the CIBMTR®, we provide long-term follow-up tracking for the first two FDA-approved CAR-T therapies. www.bethematchbiotherapies.com

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

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

Gamma Biosciences is a leading life sciences company providing products and services to support the development and manufacturing of advanced biologic therapies. Our operating companies are committed to advancing the science and art of bioprocessing by delivering market-ready innovation and expertise that helps our customers, mainly biopharmaceutical companies and contract development and manufacturing companies, safely bring therapies to patients more quickly and efficiently. Gamma is a global company with offices and major manufacturing facilities in North America, the U.K. and Belgium. www.gammabiosciences.com

Homology Medicines, Inc. is a clinical-stage genetic medicines company dedicated to transforming the lives of patients suffering from rare diseases by addressing the underlying cause of the disease. The Company’s clinical programs include HMI-103, a gene editing candidate for phenylketonuria (PKU); HMI-203, an investigational gene therapy for Hunter syndrome; and HMI-102, an investigational gene therapy for adults with PKU. Additional programs focus on paroxysmal nocturnal hemoglobinuria (PNH), metachromatic leukodystrophy (MLD) and other diseases. Homology’s proprietary platform is designed to utilize its family of 15 human hematopoietic stem cell-derived adeno-associated virus (AAVHSCs) vectors to precisely and efficiently deliver genetic medicines in vivo through a nuclease-free gene editing modality, gene therapy, or GTx-mAb, which is designed to produce antibodies throughout the body. Homology established an AAV manufacturing and innovation business in partnership with Oxford Biomedica, which was based on Homology’s internal process development and manufacturing platform. Homology has a management team with a successful track record of discovering, developing and commercializing therapeutics with a focus on rare diseases. Homology believes its initial clinical data and compelling preclinical data, scientific and product development expertise and broad intellectual property position the Company as a leader in genetic medicines. www.homologymedicines.com

IDBS helps BioPharmaceutical organizations accelerate the discovery, development and manufacturing of life-changing therapies that advance human health worldwide. From lab through manufacturing, IDBS leverages its 30+ years of experience working with a diverse list of customers – including 18 of the top 20 global BioPharma companies – and deep expertise in scientific informatics and process data management to tackle today’s most complex challenges. Known for its signature IDBS E-WorkBook product, IDBS has extended solutions across the entire value chain for BioPharma Lifecycle Management (BPLM). Built on analytics-centric and cloud-native technology, IDBS Polar and Skyland PIMS platforms are powered by a digital data backbone to drive faster and smarter decisions in drug development and across the supply chain. www.idbs.com

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.

www.landmarkbio.com

Medpace is a global full-service clinical research organization (CRO) providing comprehensive development services for drug, biologic, and device programs with a specialized focus on advanced therapies including cell and gene therapies. Medpace has strong experience supporting development programs for regenerative medicine products across a number of therapeutic areas including cardiovascular, neuroscience, musculoskeletal, and diabetes. With extensive medical expertise and a renowned regulatory affairs department across six continents, Medpace conducts studies and navigates regulatory requirements worldwide. From feasibility, research site compatibility, safety, and logistics, Medpace brings efficiencies and operational excellence to regenerative medicine development programs. In addition, Medpace offers integrated imaging and lab capabilities through its family of companies to provide cohesive, streamlined, and standardized trial management. Learn more about Medpace’s focus on cellular, tissue, and gene therapy medicines. www.medpace.com

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

Notch is an early-stage biotech company, working to maximize the benefit of cell therapies through a proprietary T cell-production platform which combines sophisticated product design with commercial-compatible processes to enhance patient outcomes. Notch’s iPSC-based technology platform allows for precision control of notch signaling, which removes several critical limiting factors in the development of cell therapies, delivering the ability to design and manufacture a uniform and unlimited supply of therapeutic T cells. www.notchtx.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

TAAV Biomanufacturing Solutions, SLU (TAAV), a wholly owned subsidiary of Asklepios Biopharmaceuticals (AskBio) and Bayer AG, is a cGMP manufacturer of neDNA™, an enzymatic DNA material used for adeno associated virus (AAV) gene therapies. neDNA™ is produced using a manufacturing process that eliminates the use of fermenters and bacteria, which are required in more common plasmid DNA manufacturing. Enzymatic manufacturing removes significant levels of bacterial contaminants, resulting in the production of enzymatic DNA product with an improved safety profile for the manufacture of recombinant adeno-associated virus (rAAV) gene therapy vectors. The TAAV manufacturing process consistently produces large amounts of neDNA using technology licensed from Touchlight IP Ltd.† in reduced times, which can be measured in days versus the months that are typical when producing plasmid DNA. TAAV was founded in 2019 and became 100% wholly owned by AskBio in 2022. Company headquarters, manufacturing facilities and labs are in San Sebastian, Spain.

†Technology for making dbDNA™, a trademark of Touchlight Genetics Ltd., is licensed from Touchlight IP Ltd.

www.taav.com

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

Interius BioTherapeutics is developing an in vivo delivery bioplatform to support a pipeline of disruptive next-generation therapeutic products. Our lead program targets hematologic malignancies by generating CAR T+NK cells directly in vivo. Our unique therapeutic approach bypasses the need for ex vivo cell manipulation and toxic lymphodepleting chemotherapy, exploring the potential for more efficacious, safer and more broadly accessible options for patients. Interius was co-founded by Dr. Saar Gill, a hematologist-oncologist and leading scientist in the fields of cell and gene therapy at the University of Pennsylvania. The company is headquartered in Philadelphia, PA. www.interiusbio.com

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.

www.nordmark-biochemicals.com

ValGenesis delivers integrated and smart solutions that support the digital transformation of the life sciences industry. With a portfolio that covers the whole product lifecycle, ValGenesis has a digital or technical solution that brings value to each step of your validation and manufacturing processes and their related activities.

www.valgenesis.com

VGXI is a leading contract manufacturer of DNA-based pharmaceuticals with over 15 years of experience providing exceptional quality GMP products to clinical trials worldwide. The company’s skilled team has an outstanding track record of success in manufacturing challenging plasmid products under GMP conditions with exceptional yield, quality, and prompt delivery. Production services include high purity plasmid DNA preparations for preclinical research, highly documented (HD) plasmid DNA manufacturing for use in GMP viral vector production or pharmacology/toxicology studies, and GMP plasmid DNA for clinical through commercial supply. In addition to standard DNA manufacturing services, VGXI announced the addition of clinical-grade mRNA production services. www.vgxii.com

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

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

www.califesciences.org

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

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.

www.ohiolifesciences.org

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.

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