CDMOs offering CMC Analytical Development with Gene Therapy
44 published
44 published CDMOs match CMC Analytical Development and Gene Therapy.
Locations in this set include United States, United Kingdom, Japan, China, Germany, and Canada.
Capabilities that show up most often in this set: Process Development, Quality Control Testing, Cell-Line Development, CMC Regulatory Submission Support, and Technology Transfer.
Matching companies
4basebio4basebio manufactures high-quality synthetic DNA and RNA using proprietary cell-free amplification technology, supporting mRNA vaccines, viral vectors, gene editing, and cell/gene therapies from research through GMP-grade clinical production.
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.
Ajinomoto Bio-Pharma ServicesAjinomoto Bio-Pharma Services is a global contract development and manufacturing organization (CDMO) dedicated to improving the health of humankind through adaptive solutions and responsive service.
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.
Argonaut Manufacturing ServicesArgonaut is a sterile fill-finish CDMO specializing in isolator-based aseptic manufacturing for biologics, peptides, nucleic acids, lipid nanoparticles, gene therapies, and vaccines from preclinical through commercial scale, with FDA and Annex 1 compliance.
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.
AsimovAsimov provides cell line development, upstream process development, and viral vector manufacturing services powered by proprietary synthetic biology platforms (CHO Edge, LV Edge, AAV Edge, RNA Edge) that deliver high-titer, stable cell lines and production systems for biologics, cell therapies, and gene therapies.
AskBioAskBio is a clinical-stage gene therapy company developing AAV gene therapies for genetic and rare disorders, with a focus on advancing genetic technology and lowering production costs to increase patient access.
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.
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.
Creative BiogeneCreative Biogene provides viral vector manufacturing, cell line development, and RNA therapeutic platforms including AAV, lentivirus, adenovirus production, circular RNA synthesis, and lipid nanoparticle formulation for gene therapy and vaccine applications.
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.
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