CDMOs offering CMC Regulatory Submission Support with Biologics (Other)
51 published
51 published CDMOs match CMC Regulatory Submission Support and Biologics (Other).
Locations in this set include United States, Germany, United Kingdom, China, India, and Japan.
Capabilities that show up most often in this set: CMC Analytical Development, Process Development, Formulation Development, Quality Control Testing, and Technology Transfer.
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.
Akron BioAkron Bio manufactures cGMP-compliant recombinant proteins, media, buffers, and transfection reagents for cell and gene therapy companies. Services span process development, fill-finish, and custom ancillary product manufacturing.
Akums Drugs and Pharmaceuticals Ltd.India's largest CDMO with 15+ state-of-the-art facilities and 30% domestic market share, manufacturing 4,100+ formulations across tablets, capsules, injectables, APIs, and specialty dosage forms under WHO-GMP, USFDA, EU-GMP, and TGA compliance.
Almac GroupGlobal CDMO with 7,900+ employees across 18 facilities, offering integrated drug development and manufacturing services including analytical development, formulation, process development, fill-finish, and specialized chemistry capabilities.
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.
ArdenaArdena is an integrated CDMO and bioanalytical CRO specializing in advanced drug product development, nanomedicine, and bioanalysis for complex molecules including poorly soluble compounds, highly potent APIs, and controlled substances.
Ascendia Pharmaceutical SolutionsAscendia 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.- Asymchem LaboratoriesAsymchem is a CDMO providing integrated API synthesis, drug product development, and biologics manufacturing with specialized capabilities in peptides, oligonucleotides, highly potent compounds, and flow chemistry.
- 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.
BioVectraNorth 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.
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.
CordenPharmaFull-service CDMO offering cGMP development and manufacturing of APIs, lipid excipients, drug products, injectables, peptides, LNPs, oligonucleotides, and oral solid dose across 10 facilities in 6 countries with 3000+ employees.
CuriRx, Inc.CuriRx, Inc. is a Wilmington, Massachusetts contract research and development organization. It offers formulation development, prefilled syringe and lyophilization services, bioprocessing, and analytical testing to pharmaceutical companies of all sizes.
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