Capability
Biologics Drug Substance CDMOs
Compare CDMOs specializing in biologics drug substance manufacturing for monoclonal antibodies, recombinant proteins, and other biologic modalities. Filter by expression system, scale, and regulatory track record.
269 companies listed
About Biologics Drug Substance Manufacturing
Biologics drug substance (DS) manufacturing produces the active biologic molecule through cell culture or fermentation, followed by purification. This is the most capital-intensive and technically demanding phase of biologic drug manufacturing, requiring specialized facilities, equipment, and scientific expertise.
Expression system selection is fundamental. CHO (Chinese Hamster Ovary) cells dominate monoclonal antibody production, typically at 2,000L-15,000L scale. E. coli fermentation is used for simpler proteins and peptides. Yeast (Pichia pastoris) handles certain glycoprotein products. Each system has different upstream, downstream, and analytical requirements.
Companies (269)
ReiThera Srl
Italy
ReiThera is an Italian CDMO dedicated to process development and GMP manufacturing of viral vectors for genetic vaccines and advanced therapy medicinal products (ATMPs). They have extensive expertise in developing scalable processes for Adeno-Associated Vectors (AAV), Lentivirus, Adenoviral vectors (AdV), Modified Vaccinia Ankara, and Herpes Simplex Vectors. Their state-of-the-art facility in Rome features stirred-tank bioreactors at 50L, 200L, 1000L, and 2000L scales, fixed-bed bioreactors, a filling suite, and quality control laboratories. They also develop their own vaccine candidates (e.g., GRAd-COV2).
Viral VectorsCell & Gene TherapyBiologics Drug Substance
Rezon Bio
Poland
Rezon Bio is a European biologics CDMO headquartered in Poland, specializing in mammalian drug substance development and GMP manufacturing. The company operates two FDA-approved facilities with mirrored capabilities, employs approximately 1,300 people (10% PhDs), and has 16 years of biologics development experience. Rezon Bio offers end-to-end services from cell line development through commercial manufacturing with 2,000L bioreactors.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
Frequently Asked Questions
What is the difference between drug substance and drug product in biologics?+
Drug substance is the bulk active biologic molecule (e.g., purified monoclonal antibody solution). Drug product is the final formulated, filled, and packaged product ready for patient use. Drug substance manufacturing involves cell culture/fermentation and purification. Drug product involves formulation, sterile filtration, fill-finish, and packaging.
How do single-use bioreactors compare to stainless steel?+
Single-use bioreactors (up to 2,000-6,000L) offer faster changeover, lower capital costs, reduced cross-contamination risk, and flexibility for multi-product facilities. Stainless steel bioreactors (up to 25,000L) offer lower per-batch costs at commercial scale and longer operational life. Most CDMOs now offer both, with single-use preferred for clinical manufacturing and stainless steel for high-volume commercial production.
Need help finding the right CDMO?
Our AI Matchmaker analyzes your project requirements and matches you with qualified manufacturing partners. Free for buyers.
