CDMOs offering CMC Analytical Development with Biologics (Monoclonal Antibodies) in United States

29 matching organizations

• 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.

• AbbVie Contract Manufacturing

  Global CMO offering small and large molecule drug substance to drug product manufacturing, with specialized capabilities in antibody drug conjugates, aseptic fill-finish, biologics (mAbs), HPAPI, and eye care across 12 facilities in the US and Europe.

• Abzena

  Fully integrated biologics and bioconjugates CDMO+CRO offering drug design, development, and GMP manufacturing for antibodies, ADCs, AOCs, RDCs, and vaccines from discovery through commercial scale.

• Asimov

  Asimov 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.

• Avid Bioservices

  Avid Bioservices is a U.S.-based mammalian cell culture CDMO providing integrated process development, analytical development, and CGMP biologics manufacturing from DNA to IND to commercial supply, with 30+ years of expertise and FDA-inspected facilities in California.

• BSP Pharmaceuticals

  BSP Pharmaceuticals is a CDMO specializing in development and manufacturing of cytotoxic oncology drugs, ADCs, peptides, proteins, and lipid-based formulations from preclinical GLP through commercial supply.

• Boston Institute of Biotechnology, LLC

  Full-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.

• 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.

• 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.

• Creative Biolabs

  Creative Biolabs provides custom recombinant antibody production, high-throughput antibody screening, GMP antibody manufacturing, and antibody biosimilar development services for biomedical research and therapeutic development.

• Curia

  Global CDMO with 30+ years of experience offering integrated services across small molecule, generic APIs, sterile drug product, and biologics manufacturing, backed by 20+ facilities and 3,000+ professionals across North America, Europe, and India.

• Cytovance Biologics

  U.S.-based CDMO offering end-to-end biomanufacturing services for antibodies, recombinant proteins, vaccines, and other biologics modalities, with dedicated microbial and mammalian facilities and in-house cell line development capabilities.

• Enzene Biosciences

  Global CDMO specializing in cost-effective biologics and biosimilars manufacturing using patented continuous bioprocess technology (EnzeneX®). Offers integrated drug discovery, development, and manufacturing services with facilities in India and expanding presence in the USA and Europe.

• 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.

• GBI Biomanufacturing

  Full-service biologics CDMO offering integrated development and manufacturing services including cell banking, upstream/downstream processing, bioconjugation, aseptic fill-finish, and regulatory support for complex biopharmaceuticals.

• Gannet Biochem

  Specialized CDMO offering custom polymer science, PEG chemistry, bioconjugation, and cGMP manufacturing services from early discovery through commercial scale, with 30+ years of expertise rooted in Shearwater Polymers and Nektar Therapeutics.

• Grand River Aseptic Manufacturing

  Sterile injectable CDMO specializing in fill-finish services for liquid and lyophilized vials, syringes, and cartridges, with Annex 1 compliant facilities and experience in biologics, small molecules, and vaccines.

• KBI Biopharma, Inc.

  Global CDMO offering cell line development, process and analytical development, formulation development, and clinical and commercial manufacturing for mammalian and microbial biologics.

• Minaris Advanced Therapies

  Pure-play cell and gene therapy CDMO with over 25 years of GMP manufacturing, process development, and biosafety testing expertise. Serves advanced therapy innovators globally from early stage through commercialization.

• National Resilience

  End-to-end CDMO specializing in complex modalities including cell, gene, and RNA-based therapies with North American manufacturing facilities and development capabilities.

• 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.

• Samsung Biologics

  Leading CDMO offering end-to-end biologics development and manufacturing from cell line development through aseptic fill-finish, with capabilities in drug substance, drug product, ADC, and mRNA services.

• Simtra BioPharma Solutions

  Simtra BioPharma Solutions is a CDMO specializing in sterile injectable development and manufacturing, including formulation, lyophilization, fill/finish, and bioconjugation services for clinical and commercial products.

• Singota Solutions

  Bloomington-based CDMO specializing in aseptic filling of small-volume parenterals (vials, syringes, cartridges), formulation development, QC testing, and supply chain management with GMP-compliant operations.

• Stevanato Group

  Leading global provider of integrated drug containment, drug delivery, and diagnostic solutions with 75+ years' experience in glass primary packaging, contract manufacturing, and analytical services across development, clinical, and commercial stages.

• 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.

• Vetter Pharma

  Independent CDMO specialist in aseptic fill-finish, drug product development, analytical services, and combination product assembly with 76 years of experience and 7,300+ employees globally.

• Wheeler Bio

  Oklahoma-based CDMO specializing in antibody-based therapeutics from cell line development through cGMP manufacturing. Offers ModularCMC platform with phase-appropriate work packages and high-touch project management.

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