CDMOs offering CMC Regulatory Submission Support with Biologics (Monoclonal Antibodies)
35 published
35 published CDMOs match CMC Regulatory Submission Support and Biologics (Monoclonal Antibodies).
Locations in this set include United States, Germany, China, Japan, India, and United Kingdom.
Capabilities that show up most often in this set: CMC Analytical Development, Process Development, Technology Transfer, Quality Control Testing, and Formulation Development.
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.
AbzenaFully 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 PharmaGlobal 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 BiologicsGlobal 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 PharmaceuticalsBSP 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.
BioconFully integrated biopharmaceutical company developing affordable biosimilars, generic formulations, and complex APIs for diabetes, cancer, and autoimmune diseases.
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.- Burrard PharmaceuticalsVancouver-based CDMO delivering technology transfer, formulation development, and GMP manufacturing for 75+ molecules across oncology, diabetes, and respiratory therapeutics since 2005.
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.
CelonicSwiss-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 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.
CuriaGlobal 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 BiologicsU.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 LaboratoriesIntegrated global pharmaceutical company manufacturing generics, APIs, biosimilars, and innovative medicines across 66 countries with capabilities in small molecule and biologics development and manufacturing.
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.
GBI BiomanufacturingFull-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 BiochemGannet BioChem is a specialized CDMO focused on activated polymer, PEG, and bioconjugation services for complex therapeutics, from early development through cGMP manufacturing. It operates facilities in Huntsville and Arab, Alabama.
Grand River Aseptic ManufacturingSterile 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.
HalixHALIX 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.
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