CDMOs offering CMC Regulatory Submission Support with Biologics (Monoclonal Antibodies)

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.

• 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.

• Adragos Pharma

  Global CDMO headquartered in Munich offering end-to-end development and manufacturing for small molecules and biologics, including sterile/non-sterile liquids, solids, semi-solids, lyophilization, and prefilled syringes across seven facilities in Europe and Japan.

• Altruist Biologics

  Global CDMO offering end-to-end development and GMP manufacturing for monoclonal antibodies, bispecific antibodies, fusion proteins, recombinant proteins, and antibody-drug conjugates, with facilities in Suzhou and Hangzhou featuring up to 20,000-liter bioreactors.

• 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.

• Biocon

  Fully integrated biopharmaceutical company developing affordable biosimilars, generic formulations, and complex APIs for diabetes, cancer, and autoimmune diseases.

• 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.

• Burrard Pharmaceuticals

  Vancouver-based CDMO delivering technology transfer, formulation development, and GMP manufacturing for 75+ molecules across oncology, diabetes, and respiratory therapeutics since 2005.

• CDMO Network

  CDMO 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.

• 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.

• Celonic

  Swiss-based pure-play biologics CDMO specializing in next-generation bioprocessing technologies including process intensification and full perfusion to reduce cost of goods for biotech and biosimilar clients.

• 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.

• 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.

• 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.

• 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.

• Halix

  HALIX is a mammalian expression CDMO specializing in viral vectors, viral vector vaccines, and recombinant proteins from development through GMP manufacturing and fill-finish at clinical and commercial scale.

• 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.

• Lupin Limited

  Global pharmaceutical manufacturer with robust quality systems aligned to US FDA, UK MHRA, and EU GMP standards; operates diversified manufacturing across generics, complex formulations, and specialty segments with advanced automation and digital quality infrastructure.

• 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.

• Pfizer CentreOne

  Award-winning CDMO specializing in commercial manufacturing of oral solids, sterile injectables, and biologic drug products with Pfizer's technical expertise and global network.

• 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.

• Piramal Pharma Solutions

  CDMO specializing in HPAPIs, ADCs, peptides, vaccines, and biologics with 4,700+ team members across 15 global sites and 500+ customers. Offers integrated development and manufacturing with backward integration capabilities and global program management.

• 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.

• Scinai Immunotherapeutics Ltd.

  Boutique biologics CDMO providing analytical method development, process development, and cGMP manufacturing for biotech clients from early research through Phase 3, backed by over 20 years of experience and state-of-the-art facilities.

• 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.

• 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.

• WuXi Biologics

  Global biologic CDMO offering end-to-end solutions from discovery to commercialization.