CDMOs offering CMC Regulatory Submission Support with Biologics (Monoclonal Antibodies) in Europe
13 matching organizations
CMC Regulatory Submission Support with Biologics (Monoclonal Antibodies) in Europe is a frequent shortlist pattern for sponsors evaluating CDMO partners with regional footprint. This page lists organizations that map to all three dimensions so you can move from broad taxonomy browsing to a geography-aware candidate set.
Profiles emphasize fit-first discovery: review scope, regulatory posture, and provenance on each listing rather than treating this page as a single ranked recommendation.
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- 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.
- 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.
- 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 Cell & Gene Therapy
Integrated CDMO offering discovery through commercial manufacturing for cell and gene therapies, with expertise in viral vectors, cell therapy manufacturing, and regulatory support across North America, Europe, and Asia.
- 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.
- 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.
- KBI Biopharma, Inc.
Global CDMO offering cell line development, process development, analytical services, and cGMP clinical and commercial manufacturing for biologics including monoclonal antibodies and recombinant proteins.
- 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.
- Simtra BioPharma Solutions
Sterile injectable CDMO specializing in formulation development, lyophilization, fill/finish, and ADC manufacturing with cGMP-compliant facilities in the U.S. and Germany.
- Simtra BioPharma Solutions
CDMO specializing in sterile injectable development and manufacturing, including formulation, lyophilization, fill/finish, and ADC services across biologics, vaccines, and small molecules.
- 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.
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