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 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.
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.
For 25 years Aldevron has been a catalyst, advancing therapeutic and vaccine development through expert plasmid DNA, RNA, and protein custom manufacturing, supporting our clients from discovery to commercialization. Our custom CDMO services have given scientists around the world essential components to accelerate their research and make a difference. Whether you're working on a gene therapy, cell therapy, or vaccine development, it starts with a high-quality DNA, RNA, or Protein.
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.
BioCentriq is a full-service, New Jersey-based CDMO for cell and gene therapy, focusing on all stages of process development and clinical manufacturing. With over 70 scientists, engineers, analysts, and manufacturing specialists, we have the quality systems and infrastructure required to support the release of both autologous and allogeneic drug products. BioCentriq also specializes in viral vector process development and manufacturing with expertise in a variety of cell and vector types.
Cardinal Health Advanced Therapy Solutions offers tailored solutions that simplify and streamline complexities of cell and gene therapies (CGT). From clinical development to commercialization, our experts will partner with you every step of the way to ensure your therapy is in the hands of patients who need it most.
Cellistic traces its origin to a single imperative: to pave the way to make cell therapy accessible. Through facilities purpose-built for that mission, we help you accelerate the development and manufacture of your cell therapies in a more reliable, affordable, and faster way, using our exclusive Pulse + Echo Platforms. These platforms ensure the highest quality starting cells are scaled and transformed as quickly as possible.
Cencora is a leading global pharmaceutical solutions organization centered on improving the lives of people and animals around the world. We partner with pharmaceutical innovators across the value chain to facilitate and optimize market access to therapies. Care providers depend on us for the secure, reliable delivery of pharmaceuticals, healthcare products, and solutions. We are united in our responsibility to create healthier futures.
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.
Charles River has supported the development of 10 FDA-approved cell and gene therapies and have conducted more than 900 studies in this field over the past year. Our unsurpassed integrated development platform from research to manufacturing offers guided navigation helping clear your path. Our mission is to accelerate commercialization of cell and therapies to create healthier lives.
For over 70 years, Charles River has provided essential products and services to help pharmaceutical and biotechnology companies, government agencies, and leading academic institutions around the globe, helping to accelerate their research and drug development efforts. With over 90 sites globally, we're ready to tackle your product's most unique challenges.
Founded in 2003 as a business unit of New York Blood Center Enterprises, Comprehensive Cell Solutions offers its deep expertise in the development and manufacture of cell and gene therapies, using its GMP and GTP facilities. CCS provides a true vein-to-vein solution, spanning fresh cellular collections and cord blood-derived stem cells as source material, to cell isolation, manipulation and cryopreservation for preclinical to commercial products.
ElevateBio is a technology-driven company built to power the development of transformative cell and gene therapies (CGTs). The company's integrated technologies model offers turnkey scale and biotechnological capabilities to power CGT processes, programs, and companies to their full potential. ElevateBio aims to be the dominant engine inside the world's greatest scientific advancements harnessing human cells and genes to alter disease.
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.
FUJIFILM Diosynth Biotechnologies is a CDMO Partner for Life. We combine technical leadership in cell culture, microbial fermentation and advanced therapies with world class cGMP manufacturing facilities and superior program management to advance tomorrow's medicines.
IDT Biologika is a global CDMO for Innovative Vaccines, Cell & Gene Therapeutics and Aseptic Fill-Finish of other biologics. We offer clients a single source CDMO partner at our sites in Germany and the USA, with seamless end-to-end solutions and the ability to nimbly scale projects from development through to commercialization. This includes Process Development, Drug Substance Manufacturing, Sterile Dosage Fill-Finish, Labelling & Packaging, Quality Control & Analytics.
With the mission of providing state-of-the-art education, training and contract services in the fast-emerging field of biopharmaceutical processing, Jefferson Institute for Bioprocessing (JIB) formally opened its doors in 2019 and is the first—and only—specialized education, training and CDMO for biopharmaceutical processing in North America. JIB's 25,000 sq. ft fully closed-processing, CNC, GMP-simulated pilot scale and process development facility houses ready-to-use technologies in fully flexible, ballroom designed suites.
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 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.
We bring 30+ years of expertise, and a global organization to integrate leading manufacturing technologies with process development, scale-up, safety testing, and the regulatory experience to meet your therapy's needs. We have more experience in this area than almost anyone else in the industry. We were the first gene therapy CDMO to produce commercial product following successful regulatory inspection.
Minaris Regenerative Medicine is a global contract development and manufacturing organization (CDMO) for cell and gene therapies. We offer our clients high value clinical and commercial manufacturing services, development solutions, and technologies. We are pioneers in the field with more than 20 years' experience providing outstanding quality and reliability. Our facilities in North America, Europe, and Asia allow us to supply patients globally with life-changing therapies.
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.
Pharmatech Associates is a global consultancy for the life science industry and advises U.S. and global drug sponsors and manufacturers to supply quality medicines in all major markets. Pharmatech Associates' domain expertise ranges from small molecule to cell and gene therapy, biologics, and advanced manufacturing technologies. Services to clients include regulatory strategy, compliance, and remediation to address manufacturing quality, CMC, and analytical method qualification.
Precision NanoSystems is a global leader in technologies, solutions and services for the development of Lipid Nanoparticle delivered genomic medicines, including mRNA vaccines and therapeutics. We support (bio)pharma companies who are ushering in the next wave of genomic medicines in infectious diseases, cancer and rare diseases. We work with the world's leading drug developers to understand disease and help create the therapeutics and vaccines that will define the future of medicine.
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.
West is a leading provider of innovative, high-quality injectable solutions and services. As a trusted partner to established and emerging drug developers, West helps ensure the safe, effective containment and delivery of lifesaving and life-enhancing medicines for patients. We are guided by our core values of Passion for Customers, Leadership in Quality and One West team and these values underpin our purpose to improve patient's lives.