CDMOs offering CMC Regulatory Submission Support with Gene Therapy

Matching companies

• AGC Biologics

  Global 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.

• Aldevron

  Aldevron 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 Biosciences

  CDMO 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 Solutions

  Ascendia 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.

• BioVectra

  North 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 AG

  GMP 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.

• Catalent

  Global 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 Therapies

  GMP 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 Catapult

  UK-based innovation and manufacturing support organization for cell and gene therapies, offering infrastructure, expertise, and collaboration across the ATMP lifecycle.

• Charles River Laboratories

  Charles 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.

• ElevateBio

  Advanced 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 Ltd

  Enable 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 Biotechnologies

  CDMO 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 Biologics

  Dedicated 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.

• Northway Biotech

  End-to-end CDMO specializing in protein-based biologics and gene therapies, with 20+ years of expertise and cGMP facilities in Lithuania and Massachusetts supporting development from preclinical to commercial stages.

• Omniabio

  OmniaBio is a cell and gene therapy CDMO specializing in process development, analytical development, and GMP manufacturing for lentiviral vectors, iPSCs, and immune cell-based therapies. The company operates a 120,000 sq ft facility in Hamilton, Ontario, integrating AI, automation, and robotics to deliver scalable manufacturing from preclinical to commercial stages.

• Oxford Biomedica

  Global 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.

• Pharmaron

  Premier 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 Advanced

  End-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.

• SK pharmteco

  SK pharmteco is a CDMO offering comprehensive drug development and manufacturing services.

• Siegfried Holding

  Global 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.

• Syngene International

  Innovation-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.

• eXmoor Pharma

  Integrated cell and gene therapy CDMO with 20+ years of consultancy expertise, offering end-to-end CMC support from early-phase strategy through GMP manufacturing across viral vectors, autologous/allogeneic cell therapies, and RNA technologies.