CDMOs offering CMC Regulatory Submission Support with Cell 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.

• Catalent

  Leading global CDMO offering end-to-end development and manufacturing for pharma, biotech, and consumer health—spanning oral dose, biologics, cell and gene therapies, clinical supply, and specialty formulations with advanced technologies and worldwide GMP capacity.

• 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.

• Celularity

  Celularity is a clinical and commercial-stage biotechnology company specializing in off-the-shelf placental-derived allogeneic cell therapies and advanced biomaterial products. The company develops mesenchymal-like adherent stromal cells (MLASCs), Natural Killer (NK) cells,…

• Charles River Cell & Gene Therapy

  Charles River provides discovery, development, and manufacturing services across the drug development continuum, including cell and gene therapy capabilities.

• Dr. Reddy's Laboratories

  Integrated global pharmaceutical company manufacturing generics, APIs, biosimilars, and innovative medicines across 66 countries with capabilities in small molecule and biologics development and manufacturing.

• 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.

• Kincell Bio

  Leading cell therapy CDMO delivering GMP manufacturing, analytics, and CMC strategy from early development through commercial launch across purpose-built U.S. facilities.

• 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.

• 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.

• Pluri

  Full-service CDMO specializing in cell therapy manufacturing with GMP facilities, proprietary packed-bed expansion technology, and regulatory approvals from FDA, EMA, PMDA, and other key agencies for clinical-stage production.

• 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.