Cell & Gene Sourcing Center
The number of clinical trials in cell and gene therapy has exploded – estimates are of over 1,000 clinical trials ongoing globally.
Many of these new therapeutic approaches require the production of viral vectors. Viral vector manufacturing today is cumbersome, and the yields are poor. If you are a startup biotech in need of viral vectors today, getting into capacity could be an issue. Complicating matters, cell and gene therapies require a certain proximity to patient and process/treatment centers, which will keep most U.S.-based drug and therapy developers looking for domestic (and regional) partners.
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Cell & Gene CMOs
AGC Biologics
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) committed to delivering the highest standard of service and collaboration to our clients and partners as we work side-by-side to help bring their products to patients across the globe. We offer world-class development and manufacturing services of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA) viral vectors, and genetically engineered cells.
Ajinomoto Bio-Pharma Services
Working with Ajinomoto Bio-Pharma Services, you get a trusted CDMO partner that has the power to make your every challenge our own, sharing your unwavering tenacity and dedication from pre-clinical program to commercial successes. We leverage our broad range of capabilities and services at our sites in Belgium, India, Japan, and the US to support your program goals.
Capabilities
Andelyn Biosciences
Andelyn Biosciences is a pioneering gene therapy organization born out of Nationwide Children's Hospital, where the first FDA-approved systemic gene therapy was discovered.
With more than 15 years of experience in AAV vector manufacturing, Andelyn is a full-spectrum CDMO. We bring scalability, capacity, efficiency and expert resources to manufacturing matrices, all to advance the development of viral vector-based therapeutics.
Capabilities
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Aragen Bioscience, Inc.
Aragen Bioscience, Inc. is focused on accelerating antibody and other biologic product development. Our integrated preclinical research offerings include: stable cell line development, recombinant protein production and purification, antibody discovery, as well as cell-based assays and in vivo models-of-disease.
Cambrex
Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With over 40 years of experience and a growing team of over 2,200 experts servicing global clients from North America and European sites, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.
Catalent
Catalent is a global leader in providing integrated services, superior drug delivery technologies and manufacturing solutions to help life science innovators develop and launch successful pharmaceuticals, biologics and consumer health products.
Capabilities
CCRM
CCRM provides innovative CDMO services to enable the development and commercialization of cell and gene therapies and regenerative medicine technologies. With our customer-focused approach customized to each client, we provide process development and cGMP manufacturing services tailored to our clients' timelines, financing, ambitions, and needs.
Capabilities
The Center for Breakthrough Medicines
CBM is a cell and gene therapy contract development and manufacturing organization (CDMO) based in the heart of Philadelphia's Cellicon Valley. CBM offers pre-clinical through commercial manufacturing capabilities including process development, plasmid DNA, viral vector manufacturing, cell banking, cell processing, and a full suite of complimentary testing and analytical capabilities. Through a single-source, end-to-end solution, CBM accelerates time to market without compromising quality.
Cytovance Biologics
Cytovance® Biologics is a biopharmaceutical contract manufacturing company specializing in the production of therapeutic proteins and antibodies from both mammalian cell culture and microbial fermentation.
Evonik
Evonik serves as a global development partner and solutions provider to biotechnology companies to help them transform complexity into value. We bring together a broad, versatile range of core competencies, a trusted global network of sites, and strong technical expertise to support you in the development, scale-up, and manufacturing of biopharmaceutical products.
Capabilities
Forge Biologics
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 to reality. Forge has a 175,000 square foot facility in Columbus, Ohio, The Hearth, to serve as its headquarters. The Hearth is a custom-designed cGMP facility dedicated to AAV vector manufacturing and will host end-to-end manufacturing services to accelerate gene therapy programs from preclinical through clinical and commercial stage manufacturing.
Genezen
Genezen 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. Genezen offers early-phase process development, GMP lentiviral vector production, retroviral 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.
iVexSol
Cell & Gene Supply Chain
iVexSol, Inc. is a viral vector manufacturing company founded on a proprietary, next generation, stable lentiviral vector production process that transforms the way these essential gene-delivery vehicles are made. Its technology will greatly reduce the complexity, cost, and development time of these critical reagents, thereby accelerating the development and enabling greater access to life-changing cell and gene therapies.
Kymanox Corporation
Kymanox is a life science professional services organization that offers engineering, scientific, and compliance support to companies exclusively in the biotechnology, pharmaceutical, medical device, and combination product industries. With its diverse team, Kymanox helps clients navigate commercialization challenges that arise throughout a product's lifecycle – from early development to post-market commercialization – with optimized safety, quality, efficacy, and accessibility.
Lonza
Lonza is a preferred global partner to the pharmaceutical, biotech and nutrition markets. We work to enable a healthier world by supporting our customers to deliver new and innovative medicines that help treat a wide range of diseases. We achieve this by combining technological insight with world-class manufacturing, scientific expertise and process excellence. Our unparalleled breadth of offerings enables our customers to commercialize their discoveries and innovations in the healthcare industry.
Oxford Biomedica
Oxford Biomedica is a leading, fully integrated, cell and gene therapy group focused on developing life-changing treatments for serious diseases.
Oxford Biomedica is your partner of choice for viral vector development scale-up, analytics and GMP processing. Leverage our extensive expertise combined with state-of-the-art bioprocessing facilities and purpose built laboratories to help you achieve successful commercialisation of your viral vector-based products.
Patheon, by Thermo Fisher Scientific
Cell & Gene Supply Chain
With a global infrastructure that enables customers to seamlessly conduct cell therapy clinical trials across multiple geographies, Patheon, by Thermo Fisher Scientific is provides patients around the world with access to life changing therapies.
Rentschler Biopharma
Rentschler Biopharma, a global leading CDMO, is your outsourcing partner of choice for bioprocess development and cGMP manufacturing. With almost 50 years of proven scientific expertise, we guarantee best-fit solutions for clinical and commercial supply. Our commitment is reflected in our exceptional client-oriented project management and regulatory support. We are headquartered in Laupheim, Germany, with a second site in Milford, MA, USA.
Capabilities
Resilience US, Inc.
Resilience is a manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions with the aim to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. Resilience seeks to offer regulatory capabilities and flexible and adaptive facilities to serve partners of all sizes.
Sharp
Sharp is a global leader in contract packaging and clinical trial supply services to the pharmaceutical and biotechnology industries. Operating from eight state-of-the art facilities across the United States and Europe, Sharp works collaboratively with pharmaceutical and biotechnology clients across the world to create unique commercial and clinical solutions for even the most complex drug products.
Capabilities
West
West is a leading manufacturer of packaging components and delivery systems for injectable drugs and healthcare products. Pharmaceutical, biotechnology, generic and medical device companies trust West and our ability to deliver consistent high-quality and technologically advanced containment and delivery solutions. We share their commitment to improving health for patients worldwide.
Capabilities
Yourway, The Biopharma Services Company
Yourway is The Biopharma Services Company changing the landscape of clinical supply chain solutions with a unique, single source model. We are the only truly integrated provider premium courier and clinical packager, supported by a global network of GMP facilities. We have the resources, experience and commitment to make your packaging and shipments faster, and management of trials easier and more efficient. Yourway delivers competitive advantage.