CDMOs offering Sterile Fill-Finish & Aseptic Manufacturing with Gene Therapy
22 published
22 published CDMOs match Sterile Fill-Finish & Aseptic Manufacturing and Gene Therapy.
Locations in this set include United States, China, United Kingdom, Denmark, Japan, and France.
Capabilities that show up most often in this set: CMC Analytical Development, Process Development, CMC Regulatory Submission Support, Viral Vector Manufacturing, 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.
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.
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.
AscendAscend is a gene-to-GMP development partner specializing in advanced biologics and vaccines with 60+ years of custom biologics expertise and 20+ years of AAV development capability. The company offers onsite fill-finish capabilities across multiple US locations and combines next-generation technologies with deep regulatory acumen.
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.
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.
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.
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.
National ResilienceEnd-to-end CDMO specializing in complex modalities including cell, gene, and RNA-based therapies with North American manufacturing facilities and development capabilities.
Oxford BiomedicaGlobal viral vector CDMO with 30 years of expertise in lentivirus, AAV, and adenovirus manufacturing. Provides end-to-end development and GMP-compliant manufacturing services from preclinical through commercial launch for cell and gene therapy programs.
Patheon (Thermo Fisher Pharma Services)Patheon is a trusted global contract development and manufacturing organization (CDMO) partner owned by Thermo Fisher Scientific, offering 360° integrated solutions from early-stage R&D through clinical supply and commercial manufacturing.
PharmaronPremier life science CRO and CDMO offering integrated R&D and manufacturing across drug discovery, preclinical, clinical development, and commercialization for small molecules, biologics, and cell & gene therapies. 25,000+ employees across China, US, and UK.
Porton AdvancedEnd-to-end ATMP CDMO provider offering cell engineering, lentiviral vectors, mRNA/LNP, plasmid development, and GMP manufacturing from preclinical through commercialization with 24 IND approvals across NMPA, FDA, and MedSafe.
Siegfried HoldingGlobal CDMO with 16 production sites across four continents, offering integrated development and manufacturing from early-phase to commercial scale for drug substance and drug product.
Symbiosis Pharmaceutical ServicesUK-based fill-finish CDMO offering rapid access to GMP aseptic manufacturing for clinical and commercial injectable drug products across mAbs, ATMPs, ADCs, RNA, peptides, vaccines, and small molecules.
Syngene InternationalInnovation-led CRDMO offering integrated scientific services from early discovery through commercial manufacturing, with cGMP-compliant facilities, 5,200+ scientists, and a new 50,000-liter single-use bioreactor capacity in the U.S.
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