October 5-7 | Arizona Biltmore
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.
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.
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.
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 CDMO focused on cell and gene therapy, specializing in viral vector development and production. With over 20 years of experience, it has produced cGMP materials for more than 500 clinical batches and 85 global trials from its facilities in Columbus, Ohio. Andelyn supports clients throughout the development process, from plasmid engineering and manufacturing to clinical and commercial production. Its Curator® Platforms enable efficient program acceleration and high-quality product delivery, with cGMP manufacturing capabilities for suspension processes up to 2,000 liters and adherent processes.
Arbor Biotechnologies™, a next-generation gene editing company based in Cambridge, MA, is advancing a pipeline of novel gene editing therapeutics to address a wide range of genetic conditions – from the ultra-rare to the most common genetic diseases. The company’s unique suite of optimized gene editors goes beyond the limitations of early editing technologies to unlock access to new gene targets and has fueled a robust pipeline of first-in-class assets focused on diseases of high unmet need. With Arbor’s lead program, ABO-101 for the treatment of primary hyperoxaluria type 1, progressing into clinical trials, the company continues to focus their research and development efforts on genomic diseases of the liver and CNS for which there are no existing functional cures.
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.
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.
Autolus is a clinical-stage biopharmaceutical company developing next-generation, programmed T cell therapies for the treatment of cancer and autoimmune disease. Using a broad suite of proprietary and modular T cell programming technologies, Autolus is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognize target cells, break down their defense mechanisms and eliminate these cells. Autolus has a pipeline of product candidates in development for the treatment of hematological malignancies, solid tumors and autoimmune diseases.
Bionova Scientific is a bespoke CDMO providing end-to-end development and GMP manufacturing services for recombinant proteins and plasmid DNA. We support biotherapeutic programs at any stage, from cell line development through commercial-ready manufacturing. Protein operations are based in Fremont, California, with a dedicated plasmid DNA facility in Houston, Texas offering plasmid design through GMP production. Founded in 2014 and acquired by Asahi Kasei in 2022, Bionova combines CDMO agility with the global resources and financial strength of a leading bioprocessing organization.
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.
BridgeBio exists to develop transformative medicines for genetic conditions. Millions of people worldwide living with genetic conditions lack treatment options, often because drug development for small patient populations can be commercially challenging. We aim to bridge the gap between advancements in genetic science and meaningful medicines for underserved patient populations. Our decentralized, hub-and-spoke model is designed for speed, precision, and scalability. Autonomous and empowered teams focus on individual conditions, while a central hub provides the clinical, regulatory, and commercial capabilities needed to bring innovation to market. For more information, visit bridgebio.com and follow us on LinkedIn, X, Facebook, Instagram, YouTube, and TikTok.
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, Inc. is a leading global contract development and manufacturing organization (CDMO) championing the missions that help people live better and healthier lives. Every product that Catalent helps develop, manufacture and launch reflects its commitment to improve health outcomes around the world through its Patient First approach. Catalent provides unparalleled service to pharma, biotech and consumer health customers, delivering on their missions to transform lives. Catalent tailors end-to-end solutions to meet customers’ needs in all phases of development and manufacturing. With thousands of scientists and technicians and the latest technology platforms at nearly 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.
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
Cellares is the first Integrated Development and Manufacturing Organization (IDMO) and takes an Industry 4.0 approach to mass manufacturing the living drugs of the 21st century. The company is both developing and operating integrated technologies for cell therapy manufacturing to meet the total patient demand for cell therapies globally.
Cellbox Solutions develops innovative logistics solutions for the global BioMed industry. Its flagship product, a portable incubator with active CO₂ and temperature control, ensures the safe transport of living cells and biological samples under optimal laboratory conditions. The concept originated at Fraunhofer EMB in Lübeck, where researchers needed a solution to transport fragile biological material and cells while maintaining constant conditions of 37°C and 5% CO₂. Within 18 months, a team of engineers and biologists developed fully functional and robust Cellbox™. Today, Cellbox Solutions collaborates closely with more than 150 customers to tackle diverse cell transport challenges and continuously improve its products. The development and assembly of Cellbox™ incubators were carried out in partnership with Fraunhofer EMB, and is now supported by an European EIC grant. Since this year, Cellbox™ has also established a collaboration with Biospherix, a US company specializing in closed-system cell culture technologies.
Cencora has a proven history of collaborative partnership, bringing complex and transformative therapies to market. From clinical to commercial and every point between, we strive for accelerated speed to market and better outcomes. We offer:
– A full continuum of strategic consulting services, providing the right resources at the right time
– Vast provider reach and patient services experience enabling deep connection and support across key stakeholders
– Proven expertise guiding therapies through the commercialization journey within a global footprint
– A global team of SMEs eager to innovate and flex to meet your unique needs
Our 46,000+ worldwide team members contribute to positive health outcomes through the power of our purpose: We are united in our responsibility to create healthier futures.
C3i is a one-stop-shop in the development chain of cell & gene therapy. With a proven 15-year track record of success, boasting a 99% manufacturing success rate across in over 300 clinical productions, we offer tailored services to meet client needs. Our in-house, turnkey services ensure a streamlined process, eliminating the need to transfer your technology between multiple sites. We have extensive expertise in diverse cell manufacturing and deliver cost-effective solutions. Our attractive COGS, with prices 25% lower than other US/EU CDMOs, make us a fiscally sound partner. Additionally, we provide comprehensive analytical testing, including validated Qc services, for complete quality assurance. We stand out in the CDMO field through our unique shared-risk model. By investing in innovative companies and offering in-kind services, we partner with you to turn ground-breaking cell and gene therapies into reality.
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.
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 health innovation district in downtown Rochester, developed through the Destination Medical Center (DMC) initiative, a $5.6 billion, 20-year public-private investment anchored by Mayo Clinic. Located just 495 steps from Mayo Clinic’s downtown campus, the district brings together biotechnology companies, researchers, clinicians, entrepreneurs, investors, and strategic partners to accelerate the development and commercialization of breakthrough healthcare technologies. Anchored by One and Two Discovery Square, the district provides state-of-the-art laboratory and office space for Mayo Clinic programs, industry partners, startups, and higher education institutions. Discovery Square is also home to BioLabs Rochester, the Midwest’s first BioLabs location, providing turnkey laboratory space for emerging life science companies and direct access to Mayo Clinic, the Center for Regenerative Biotherapeutics, and Rochester’s growing innovation ecosystem. More than a collection of buildings, Discovery Square is an intentionally curated innovation ecosystem where scientific discovery, clinical expertise, translational research, talent, capital, and industry partners come together to help companies validate, commercialize, and scale the next generation of diagnostics, therapeutics, and advanced biomanufacturing technologies.
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.
ElevateBio is a technology-driven advanced therapy contract development and manufacturing organization (CDMO) powering the creation of life-transforming therapies. The company helps biopharmaceutical partners design, develop, and manufacture therapies from early discovery through commercialization, combining proprietary gene editing technologies and discovery services, cGMP manufacturing capabilities, and industry-leading expertise to accelerate development across a breadth of therapeutic approaches and modalities. Through continuous investment in automation, AI, and next-generation technologies, ElevateBio delivers the quality, speed, and scale partners need to bring advanced therapies to more patients.
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.
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.
Franklin Biolabs is a fully integrated preclinical CRO accelerating the global development of transformative next-generation therapies. Our state-of-the-art facility, commitment to quality, and scientific expertise make us a trusted partner for global biotech, pharma, and academic institutions. At the forefront of genetic and biologic therapy innovation, Franklin Biolabs has a strong track record of advancing breakthrough therapies from concept to clinic. Our mission is to empower innovators by providing cutting-edge platform solutions and end-to-end support across the full development journey, from discovery through commercialization. Our dedicated and experienced team delivers seamless, superior customer service and expert project management, ensuring each partnership achieves its scientific and business goals efficiently. By combining deep expertise in genetic medicines and biologics with a commitment to innovation, we help clients turn pioneering ideas into therapies that change lives.
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.
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.
GeneFab is a contract research and manufacturing organization focused on cell and gene therapies. GeneFab was formed in 2023 with a vision to combine industry leading expertise in synthetic biology with advanced cGMP capabilities in order to accelerate the development and commercialization of genetic medicines. GeneFab capabilities spans early stage product design, technical development and cGMP compliant production including CAR-T/CAR-NK Cells, iPSCs, engineered cell banks, AAV, lentiviral vectors, gamma-retroviral vectors, mRNA, LNP and pDNA. GeneFab’s technology platform includes bioinformatic-guided discovery of cell type promoters, directed evolution of small molecule-regulated gene switches, the engineering of highly sensitive kill switches for enhanced safety and control of cellular therapies, and innovator-centric manufacturing platforms to accelerate novel therapies to patients in need. Across two facilities in Alameda and South San Francisco and facility soon in Singapore, GeneFab employs approximately 100 employees, including experts in cell, gene, and nucleic acid therapy, CMC, analytical development, process development and synthetic biology.
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.
Harnessing over 60 years of experience, Germfree provides end-to-end solutions for the next generation of pharmacy, biocontainment, and biopharma cleanroom technologies. We are a leading provider of cutting-edge equipment and facilities for a variety of industries and applications. Our team ensures that our facilities and equipment are designed and built to the highest quality standards and meet the most stringent regulatory requirements. We take pride in our ability to customize our manufacturing process to suit your specific requirements, while taking care of all aspects of the process, leaving you free to focus on what matters most. At Germfree, we recognize you are doing the world’s most important work. We are here to help share the load. This is why we go beyond manufacturing to deliver turnkey solutions tailored to the unique needs of our clients. We understand the challenges you face and we are deeply committed to providing holistic, end-to-end services that address your specific concerns.
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.
Harro provides more than just production and packaging systems across all industrialization stages and comprehensive services for pharmaceutical and medical technology companies worldwide. We design and realize highly specialized process solutions for unique, niche applications in the pharma and biotech industries. And we contribute our expertise and experience throughout the entire lifecycle of your product, partnering as early as the initial development of your vision. No matter where we start, we shape a process that can grow from the lab scale to fully automated high-performance production. www.hoefliger.com
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.
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.
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 engineers cells into therapies. 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, with expertise in analytical and process development and GMP manufacturing, testing, and release from early clinical, to pivotal studies and product launch. Kincell Bio is focused on supporting innovative companies developing immune cell therapies, including autologous and allogeneic CAR-T, TCRs, Tregs, and CAR-NK programs, and on developing expertise in stem cell products and iPSCs.
Kyverna Therapeutics is a clinical-stage biopharmaceutical company focused on liberating patients through the curative potential of cell therapy. Kyverna’s lead CAR T-cell therapy candidate, KYV-101, is advancing through late-stage clinical development with registrational trials for stiff person syndrome and myasthenia gravis, and two ongoing multi-center Phase 1/2 trials for patients with lupus nephritis. The company is also harnessing other KYSA trials and investigator-initiated trials, including in multiple sclerosis, to inform the next priority indications for Kyverna to advance into late-stage development. Additionally, its pipeline includes next-generation CAR T-cell therapies in both autologous and allogeneic formats, including efficiently expanding into broader autoimmune indications and the potential to increase patient reach with KYV-102 using its proprietary whole blood rapid manufacturing process.
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.
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, the U.S. and Canada Life Science business of Merck KGaA, Darmstadt, Germany, delivers expertise and innovation in cell and gene therapy development and manufacturing, enabling clients to advance life-changing therapies from early development through commercialization. With over 30 years of experience in viral vectors manufacturing and 75+ years of testing experience, our experts collaborate with leading pharmaceutical and biotechnology companies to provide development and manufacturing support for lentivirus, adeno-associated virus (AAV), adenovirus, and other viral vectors. MilliporeSigma’s viral vector CDMO state-of-the-art facility in Carlsbad, CA offers end-to-end capabilities, including process and analytical development, suspension and adherent GMP production, fill/finish, and on-site product testing and regulatory support. We leverage optimized solutions such as lentiviral vector and AAV platforms to deliver reliable, high-quality viral vectors. Our BioReliance® biosafety testing and analytical development services deliver risk-mitigating solutions with technical and regulatory expertise. We partner with clients through the product cycle, from early pre-clinical development through licensed production. Let`s accelerate your viral vector-based therapies and cell therapies, reduce risk, and bring life-changing treatments to patients faster.
www.sigmaaldrich.com/services/contract-manufacturing/viral-vector-manufacturing
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.
Minaris is a global cell and gene therapy (CGT) CDMO and multimodal biosafety testing organization. With more than 25 years of CGT development and manufacturing expertise and more than 40 years in biosafety testing, Minaris combines deep legacy experience with state-of-the-art GMP facilities as a fully U.S.-owned organization under new ownership and management, built for today’s evolving therapeutic landscape. Through its divisions, Minaris Advanced Therapies and Minaris Advanced Testing, the company supports innovators from IND through commercial supply and delivers GMP analytics, biosafety, viral clearance, and product characterization across CGT and biologics. With five global sites across three continents, Minaris is committed to helping partners bring more therapies to more patients worldwide.
At Miromatrix, we are pioneering a novel technology with the goal of developing fully transplantable human organs. Using the science behind our patented technology, we are working to develop bioengineered human organs in hopes of providing new options for transplantation. We believe our approach may provide an efficient way to answer the unmet need of thousands of patients across the country who will otherwise go without the transplant they need to survive and thrive.
The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) is a public-private partnership whose mission is to accelerate biopharmaceutical innovation, support the development of standards that enable more efficient and rapid manufacturing capabilities, and educate and train a world-leading biopharmaceutical manufacturing workforce, fundamentally advancing U.S. competitiveness in this industry. NIIMBL is part of Manufacturing USA®, a diverse network of federally-sponsored manufacturing innovation institutes. NIIMBL is funded through a $70 million cooperative agreement with the National Institute of Standards and Technology (NIST) in the U.S. Department of Commerce and leverages additional commitments from our partners.
Advanced Instruments has merged with Nova Biomedical and we are excited to share our larger portfolio with you at Cell & Gene Meeting on the Mesa. Artel®, Solentim®, BioProfile®, and the OsmoTECH® portfolio together form a comprehensive suite of advanced analytical and automation solutions designed to accelerate bioprocessing and cell line development workflows. From ensuring liquid handling accuracy with Artel®, to enabling single‑cell cloning and imaging with Solentim®, to delivering real‑time bioprocess analytics through BioProfile® and precise osmolality measurement with OsmoTECH®, the portfolio supports critical decisions from early development through manufacturing. Together, these technologies help biopharma teams improve data integrity, increase efficiency, and confidently advance complex biologics to market.
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.
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.
PackGene Biotech is a leading CRO/CDMO specializing in adeno-associated virus (AAV), mRNA, plasmid DNA, and lentiviral vector (LVV) solutions. Supporting early-stage discovery, preclinical development, and cell and gene therapy programs, we provide reliable, cost-effective, and scalable production services. Our π-Alpha 293 AAV High-yield Platform improves AAV yield by up to tenfold and supports large-scale batches up to 1E+17 vg, meeting most clinical and commercial project needs. We also offer customized plasmid DNA services, covering design, production, and manufacturing, with GMP plasmid production scales from 5 L to 200 L. In addition, PackGene provides process development, analytical development, and cell banking support for AAV, LVV, and plasmid projects. Our mRNA and LNP solutions further support drug and vaccine development from research to GMP production. www.packgene.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.
At Peli BioThermal, we lead the way in temperature-controlled packaging and service solutions for the global life sciences industry. Our award-winning shippers are trusted worldwide to safeguard critical treatments, ensuring they remain safe, effective, and ready to save lives, no matter the conditions. Most importantly, we understand that lives are on the line with every package shipped. That’s why we are passionate about delivering the highest quality, cost effective and accessible shippers on the market; and we don’t stop there. Our product suite is backed by a complete portfolio of services, including rental, lease and managed inventory options, as well as software to support your end-to-end temperature controlled packaging asset management.
Precision Medicine Group (Precision) was founded in 2012 because a new era of precision medicine was emerging and there was an unmet need for the infrastructure, capabilities and expertise required to advance development and access to these complex treatments. Precision was purpose-built to support the challenges of making novel therapies accessible to patients —from clinical development to commercialization. PMG Comprises two powerful divisions: Precision for Medicine (PFM) is the premier provider of biomarker-driven contract research organization services, purposefully designed to support the development of next-generation medicines. Precision AQ is the foremost provider of commercialization services ensuring access to these advanced therapies. Precision nurtures scientific innovation in every stage from molecule to market to bring new treatments to patients in need. Deep oncology, autoimmune, and rare disease expertise sets Precision’s global CRO services apart, leveraging technologies like genomics, bioinformatics and data analytics, along with services including specialty labs, annotated biospecimens, and companion diagnostics with IVD regulatory support. PFM’s integrated capabilities in trials, laboratory services, biospecimens, and data sciences drive faster clinical development and drug approval. Proficiency in oncology has helped biotechs and pharma on the frontlines of cancer treatment navigate complex early-stage drug development. Precision supported many oncology firsts, including the first PD-1 inhibitor, first CAR T-cell therapy and first T-cell therapy for solid tumors. Additionally, Precision launched Precision AQ Oncology, an integrated delivery team connecting Medical Communications, Global Market Access, Investor Relations, and Commercial Readiness to generate evidence, define product value, and deliver insights that accelerate informed oncology decision-making.
Project Farma is a patient-focused global leader in advancing technical operations from ideation through commercialization with a proven track record of planning, building, and maintaining manufacturing facilities, capital expansions, and technical operations for complex biologics and novel modalities. Project Farma has executed 100+ facility builds, retrofits and expansions, managed 400+ large-scale capital projects, industrialized 10+ commercial cell, gene, and novel therapies, and managed $6B+ in technical operations capital investments. Partnering with leading pharmaceutical companies, advanced therapy organizations, universities, hospitals, and government agencies, our team of experts drives innovation in technical operations and manufacturing to support the advancement of groundbreaking therapies for patients in need.
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.
At Roche CustomBiotech, we understand the technical complexity involved in implementing transformative advanced therapy medicinal products (ATMPs). Our commitment is to be your dedicated partner in providing tailored solutions for manufacturing advanced therapeutics. By producing defined, scalable raw materials with robust quality control solutions, we support manufacturing efficiency and compliance with regulatory requirements. Located in our state-of-the-art biotechnology facility in Penzberg, Germany, we combine the expertise of pharma and diagnostics with decades of experience producing high-quality raw materials. Join us in advancing cell and gene therapies from cell isolation to quality control release testing. www.custombiotech.roche.com
Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT) is a fully integrated biotechnology company advancing gene therapies for rare and devastating cardiovascular diseases, with additional programs in hematology and immunology. Rocket’s cardiovascular pipeline includes three clinical stage programs that each target one of the major inherited cardiomyopathy subtypes: hypertrophic, arrhythmogenic, and dilated cardiomyopathies. Together these conditions represent more than 100,000 patients in the U.S. and EU. The Company’s platform is supported by proprietary AAV manufacturing capabilities, multiyear efficacy and safety data in cardiac gene therapy, and experience treating several cardiac patients across late-stage AAV programs. Follow us on LinkedIn, YouTube, and X.
Rose BioSolutions is an integrated cell sourcing and manufacturing partner for cell and gene therapies. We accelerate development timelines and reduce handoffs from early research to commercial supply. Formed in 2026 from established CDMO and Cell Solutions businesses, Rose BioSolutions delivers end-to-end products and services spanning RUO and GMP human immune and stem cells, plasmid DNA, viral vectors, and cell therapy manufacturing, connecting all the pieces your program needs under one roof. With deep expertise, global infrastructure, and decades of legacy experience, Rose BioSolutions supports programs across the complete spectrum. From cell sourcing through process design, regulatory strategy, and scalable GMP production, helping clients advance their science faster.
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.
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.
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.
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.
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 global/ world class 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.
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.
uniQure is delivering on the promise of gene therapy – single treatments with potentially curative results. The approvals of uniQure’s gene therapy for hemophilia B – an historic achievement based on more than a decade of research and clinical development – represent a major milestone in the field of genomic medicine and ushers in a new treatment approach for patients living with hemophilia. uniQure is now advancing a pipeline of proprietary gene therapies for the treatment of patients with Huntington’s disease, refractory temporal lobe epilepsy, Fabry disease, and other severe diseases.
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
