CDMOs offering CMC Regulatory Submission Support with Gene Therapy
32 published
32 published CDMOs match CMC Regulatory Submission Support and Gene Therapy.
Locations in this set include United States, China, United Kingdom, Denmark, France, and Germany.
Capabilities that show up most often in this set: Process Development, CMC Analytical Development, Quality Control Testing, Technology Transfer, and Cell-Line Development.
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.
AdvaxiacGMP CDMO specializing in adenovirus vaccine development and manufacturing with a 100% batch approval rate and 10+ years of biologics expertise, serving major pharmaceutical and biotech clients.
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.
Ascendia Pharmaceutical SolutionsAscendia is a specialty CDMO providing formulation development, analytical services, and GMP manufacturing for small molecules and biologics from pre-formulation through commercialization, with proprietary nanotechnologies including LipidSol, EmulSol, AmorSol, and NanoSol.
BioVectraNorth American CDMO specializing in clinical-to-commercial biologics, small molecules, HPAPIs, and bioreagents with 50+ years of microbial fermentation and complex chemistry expertise across cGMP facilities in Canada.
Biomay AGGMP CDMO specializing in plasmid DNA, mRNA, and recombinant protein manufacturing from gene construction to market supply, with in-house mRNA lipid-nanoparticle formulation and aseptic fill-finish capabilities.
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.
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.
CuriRx, Inc.CuriRx, Inc. is a Wilmington, Massachusetts contract research and development organization. It offers formulation development, prefilled syringe and lyophilization services, bioprocessing, and analytical testing to pharmaceutical companies of all sizes.
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.
Forge BiologicsDedicated AAV gene therapy CDMO with a 200,000+ sq. ft. cGMP facility featuring 20 suites and bioreactors up to 5,000L, supporting 60+ clients across 35+ indications with high-yield manufacturing and seamless regulatory compliance.- 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.
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