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.
50 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 (50)
N
NovaPharma B.V.
Netherlands
NovaPharma B.V. is a leading contract development and manufacturing organization headquartered in Netherlands. We specialize in Commercial Manufacturing, Small Molecule API Manufacturer with state-of-the-art facilities serving clients globally.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
IGS B.V.
Netherlands
IGS B.V. is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
H
Himachal Polyolefins Ltd
India
Himachal Polyolefins Ltd is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
ChemCon GmbH
Germany
ChemCon GmbH is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
AM Instruments
Italy
AM Instruments is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
ABFEN FARMA
Turkey
ABFEN FARMA is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
C
Coriolis Pharma Research GmbH
Germany
Coriolis Pharma Research GmbH is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
G
Grace Davison Chemicals (India) Pvt Ltd
India
Grace Davison Chemicals (India) Pvt Ltd is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
P
Praveen Laboratories Pvt Ltd
India
Praveen Laboratories Pvt Ltd is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
Cleo Singapore
Singapore
Cleo Singapore is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
Kekule Pharma Limited
India
Kekule Pharma Limited is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
Nanomol Technologies S.A.
Spain
Nanomol Technologies S.A. is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
P
PrimePharma GmbH
Ireland
PrimePharma GmbH is a leading contract development and manufacturing organization headquartered in Ireland. We specialize in Formulation Development, Clinical Trial Materials, Biologics Manufacturer with state-of-the-art facilities serving clients globally.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
BioFusion JSC
Poland
BioFusion JSC is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
C
Chemoforma AG
Switzerland
Chemoforma AG is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
Loxim Industries Limited
India
Loxim Industries Limited is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
P
PurCell Bio
United States
PurCell Bio is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
C
Caplin Point Laboratories / Caplin Steriles
India
Caplin Point Laboratories / Caplin Steriles is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
A
ApexPharma Corp.
Belgium
ApexPharma Corp. is a leading contract development and manufacturing organization headquartered in Belgium. We specialize in Small Molecule API Manufacturer, Commercial Manufacturing, Packaging with state-of-the-art facilities serving clients globally.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
Centroflora Group
Brazil
Centroflora Group is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
I
ITECO Engineering
Italy
ITECO Engineering is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
Macleods Pharmaceuticals Ltd
India
Macleods Pharmaceuticals Ltd is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
A
AdvancedPharma GmbH
Spain
AdvancedPharma GmbH is a leading contract development and manufacturing organization headquartered in Spain. We specialize in Small Molecule API Manufacturer, Biologics Manufacturer with state-of-the-art facilities serving clients globally.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
Peter Greven Nederland C.V.
Netherlands
Peter Greven Nederland C.V. is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
R
RNP Pharmachem
India
RNP Pharmachem is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
Fabtech Technologies International Ltd.
India
Fabtech Technologies International Ltd. is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
Interos Inc.
France
Interos Inc. is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
YCP Consus / Consus Global
Indonesia
YCP Consus / Consus Global is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
GL Biochem (Shanghai) Ltd.
China
GL Biochem (Shanghai) Ltd. is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
CBL Patras S.A.
Greece
CBL Patras S.A. is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
A
Aptuit LLC
Italy
Aptuit LLC is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
Oleochemicals India Pvt. Ltd.
India
Oleochemicals India Pvt. Ltd. is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
LOTTE BIOLOGICS
South Korea
LOTTE BIOLOGICS is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
TekniPlex (TekniPlex Healthcare)
Italy
TekniPlex (TekniPlex Healthcare) is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
Softgel Healthcare Pvt Ltd
India
Softgel Healthcare Pvt Ltd is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
SKYEPHARMA (Skyepharma Productions SAS)
France
SKYEPHARMA (Skyepharma Productions SAS) is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
Berlin‑Chemie (Menarini Group)
Germany
Berlin‑Chemie (Menarini Group) is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
Pharmchem
United States
Pharmchem is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
RENOLIT Healthcare
China
RENOLIT Healthcare is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
Laboratorios Salvat, S.A.
Spain
Laboratorios Salvat, S.A. is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
Medisky Pharmaceuticals Pvt Ltd
India
Medisky Pharmaceuticals Pvt Ltd is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
E
Elysium Pharmaceuticals Ltd.
India
Elysium Pharmaceuticals Ltd. is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
Normon
Spain
Normon is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
C
Canaan Technology Group (Zhejiang Canaan Technology Co., Ltd.)
China
Canaan Technology Group (Zhejiang Canaan Technology Co., Ltd.) is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
Douglas CDMO
United Kingdom
Douglas CDMO is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
The Ritedose Corporation
United States
The Ritedose Corporation is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
N
Newland Pharmaceutical Co. Ltd
China
Newland Pharmaceutical Co. Ltd is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
Nobel Ilac Sanayii Ve Ticaret A.S.
Kazakhstan
Nobel Ilac Sanayii Ve Ticaret A.S. is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
Oliver Healthcare Packaging
China
Oliver Healthcare Packaging is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
F
FusionPharma B.V.
Germany
FusionPharma B.V. is a leading contract development and manufacturing organization headquartered in Germany. We specialize in Fill/Finish, Packaging with state-of-the-art facilities serving clients globally.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
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.