CDMOs offering CMC Regulatory Submission Support with Cell Therapy
28 published
28 published CDMOs match CMC Regulatory Submission Support and Cell Therapy.
Locations in this set include United States, China, Japan, United Kingdom, Denmark, and Australia.
Capabilities that show up most often in this set: Process Development, CMC Analytical Development, Cell Therapy Manufacturing, Cell-Line Development, and Quality Control Testing.
Matching companies
AGC BiologicsGlobal CDMO offering development and manufacturing for protein expression biologics, pDNA, mRNA, viral vectors (AAV, LVV, RVV), and genetically engineered cells with scale-out manufacturing capabilities.
Akron BioAkron Bio manufactures cGMP-compliant recombinant proteins, media, buffers, and transfection reagents for cell and gene therapy companies. Services span process development, fill-finish, and custom ancillary product manufacturing.
AldevronAldevron is a CDMO specializing in mRNA manufacturing with LNP encapsulation and fill/finish, viral vector production, plasmid DNA, and gene therapy solutions from discovery through commercialization.
Andelyn BiosciencesCDMO specializing in plasmid DNA and AAV viral vector manufacturing for cell and gene therapy, with digital-first platform emphasizing data integrity and collaboration.
Boston Institute of Biotechnology, LLCFull-service CDMO offering cGMP and non-GMP mammalian, microbial, gene therapy, and cell therapy manufacturing from preclinical to commercial scale, with bioreactor capacity up to 50,000L.
CDMO NetworkCDMO Network is a biomanufacturing partner-routing platform that connects biotech sponsors with specialized CDMO partners across modalities, development stages, and geographies to reduce integration friction and accelerate program execution.
CatalentGlobal CDMO providing end-to-end contract development and manufacturing for pharma, biotech, and consumer health. Delivers 60+ billion doses annually across small molecules, biologics, cell & gene therapies, and clinical supply.
Cell TherapiesGMP contract manufacturer of autologous and allogeneic cell therapies from first-in-human trials through commercial supply, with two decades of experience in CAR-T, mesenchymal stromal cells, TILs, and pluripotent stem cell derivatives. Offers end-to-end cold chain management, process development, quality control analytics, and regulatory consulting across Australia and Asia-Pacific.
Cell and Gene Therapy CatapultUK-based innovation and manufacturing support organization for cell and gene therapies, offering infrastructure, expertise, and collaboration across the ATMP lifecycle.
Cellab CDMOCell and gene therapy CDMO providing cell banking, GMP manufacturing, cryopreservation and EU QP batch release for clinical-stage ATMPs. Operates a 1,000 m² facility with four Grade B and one Grade C cleanroom plus an AABB-accredited cell bank.
CellaresCellares operates a global network of Smart Factories delivering integrated development and manufacturing (IDMO) services for cell therapies, with proprietary Cell Shuttle® and Cell Q™ platforms enabling cGMP-compliant, automated manufacturing and quality control at clinical and commercial scale.
CelularityCelularity is a clinical and commercial-stage biotechnology company specializing in off-the-shelf placental-derived allogeneic cell therapies and advanced biomaterial products.
Charles River LaboratoriesCharles River Laboratories provides contract research, development, and manufacturing services across the full drug discovery and development continuum, supporting 80% of FDA-approved drugs over the past five years.
Dr. Reddy's LaboratoriesIntegrated global pharmaceutical company manufacturing generics, APIs, biosimilars, and innovative medicines across 66 countries with capabilities in small molecule and biologics development and manufacturing.
ElevateBioAdvanced therapies CDMO providing discovery, process development, manufacturing, and regulatory support for cell therapies, viral vectors, mRNA, and gene editing programs from preclinical through commercial scale.
Enable Biotech LtdEnable Biotech provides clinical GMP manufacturing for cell therapies, exosome therapies, and gene therapies, with SwissMedic accreditation pending for gene therapy operations as of summer 2024.
FUJIFILM BiotechnologiesCDMO partner offering end-to-end biologics development and manufacturing from pre-clinical through commercialization, with expertise in cell culture, microbial fermentation, cell and gene therapy, and cGMP manufacturing across US and European facilities.- HillgeneHillgene is a leading CDMO provider specializing in cell therapy manufacturing, offering end-to-end solutions for CAR-T, TCR-T, CAR-NK, and UCAR-T cell therapies with GMP facilities in Suzhou and Belgium.
Kincell BioLeading cell therapy CDMO delivering GMP manufacturing, analytics, and CMC strategy from early development through commercial launch across purpose-built U.S. facilities.
Made ScientificCell therapy CDMO offering end-to-end development, GMP manufacturing, and regulatory support from preclinical through commercial scale, with specialized expertise in T cells, NK cells, MSCs, iPSCs, and other cell modalities.
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