CMC and manufacturing
Biologics CDMOs.
Contract development and manufacturing organizations documenting biologics process development and GMP manufacturing, segmented by modality, expression platform, drug substance or drug product, and stage. 20 published profiles.
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20 providers
Ordered alphabetically. No paid placement.
3PBIOVIAN
3pbiovian.com
3PBIOVIAN, formed from 3P Biopharmaceuticals and Biovian, describes process, cell line and analytical development and GMP manufacturing of microbial and mammalian proteins, including monoclonal antibodies, plus AAV and adenovirus vectors and plasmid DNA, for drug substance and in-house fill and finish, from preclinical to commercial supply. It lists manufacturing sites in Noáin (Pamplona), Spain and Turku, Finland.
- Services
- Analytical development and QC testing · Cell line development · Clinical packaging and labeling · Formulation development · GMP drug product manufacturing · GMP drug substance manufacturing · Process development · Stability studies · Technology transfer
- Specialties
- Mammalian cell culture · Microbial fermentation · Single-use bioreactors · Cell therapies
- Locations
- Europe · North America
View profileSources reviewed November 4, 2026
Abzena
abzena.com
Abzena describes cell line development (CHO), process development and cGMP drug substance manufacturing of monoclonal antibodies and recombinant proteins at San Diego, CA, using single-use bioreactors, for clinical and commercial supply. Its Bristol, PA site documents bioconjugation, ADC and highly potent manufacturing; a Cambridge, UK site covers discovery. Corporate headquarters are in Raleigh, NC.
- Services
- Analytical development and QC testing · Bioconjugation (ADC) · Cell line development · Formulation development · GMP drug substance manufacturing · Highly potent APIs · Process development · Stability studies · Technology transfer
- Specialties
- Mammalian cell culture · Single-use bioreactors · Antibody-drug conjugates · Monoclonal antibodies
- Locations
- Europe · North America
View profileSources reviewed November 4, 2026
AGC Biologics
agcbio.com · Part of AGC Inc.
AGC Biologics describes process, cell line, analytical and formulation development and cGMP drug substance manufacturing of mammalian and microbial proteins, including monoclonal antibodies, plus mRNA, viral vectors and cell therapies, from Phase I to commercial supply. It lists headquarters in Bothell, WA and sites in Copenhagen, Heidelberg, Milan, Chiba and Yokohama, and states it is part of AGC Inc.
- Services
- Analytical development and QC testing · Cell line development · Formulation development · GMP drug product manufacturing · GMP drug substance manufacturing · Lyophilization · Process development · Stability studies · Technology transfer
- Specialties
- Mammalian cell culture · Microbial fermentation · Single-use bioreactors · Cell therapies
- Locations
- Asia-Pacific · Europe · North America
View profileSources reviewed November 3, 2026
Aragen
aragen.com
Aragen, a CRDMO that also serves small-molecule programmes, describes biologics cell line development (CHO) in Morgan Hill, California and upstream, downstream and analytical development and cGMP clinical drug substance manufacturing of monoclonal antibodies in single-use bioreactors at Jigani, Bengaluru, India. Biologics drug product manufacturing is not documented. Its global headquarters is in Hyderabad, India.
- Services
- Analytical development and QC testing · Cell line development · Formulation development · GMP drug substance manufacturing · Process development · Stability studies · Technology transfer
- Specialties
- Mammalian cell culture · Single-use bioreactors · Monoclonal antibodies
- Locations
- Asia-Pacific · North America
View profileSources reviewed November 4, 2026
Avid Bioservices
avidbio.com
Avid Bioservices describes cell line, process, analytical and liquid formulation development and CGMP drug substance manufacturing of monoclonal antibodies and recombinant proteins in CHO cells, from Phase I to commercial supply, plus conjugation of ADCs with non-potent payloads. It lists headquarters and manufacturing in Tustin, CA and an early-phase center in Costa Mesa, CA.
- Services
- Analytical development and QC testing · Bioconjugation (ADC) · Cell line development · Formulation development · GMP drug substance manufacturing · Lyophilization · Process development · Stability studies · Technology transfer
- Specialties
- Mammalian cell culture · Single-use bioreactors · Antibody-drug conjugates · Monoclonal antibodies
- Locations
- North America
View profileSources reviewed November 3, 2026
Bionova Scientific
bionovascientific.com · Part of Asahi Kasei
Bionova Scientific describes mammalian cell line development, process, analytical and formulation development, and GMP manufacturing of monoclonal antibodies and recombinant proteins from DNA to bulk drug substance in single-use bioreactors, at a facility described as commercial-ready and producing clinical supply. It lists headquarters in Fremont, CA, and is described as a subsidiary of Asahi Kasei.
- Services
- Analytical development and QC testing · Cell line development · Formulation development · GMP drug substance manufacturing · Process development · Stability studies
- Specialties
- Mammalian cell culture · Single-use bioreactors · Monoclonal antibodies · mRNA and nucleic acids
- Locations
- North America
View profileSources reviewed November 4, 2026
Celonic
celonic.com
Celonic documents cell line development (CHO), process and analytical development and GMP drug substance manufacturing for monoclonal antibodies, bispecifics and fusion proteins, from clinical supply to commercial manufacturing. It lists its headquarters and development center in Basel, Switzerland, and single-use GMP manufacturing in Heidelberg, Germany.
- Services
- Analytical development and QC testing · Cell line development · GMP drug substance manufacturing · Process development · Stability studies · Technology transfer
- Specialties
- Mammalian cell culture · Single-use bioreactors · Monoclonal antibodies · Recombinant proteins
- Locations
- Europe
View profileSources reviewed November 3, 2026
Curia
curiaglobal.com
Curia describes mammalian cell line and process development and GMP drug substance manufacturing of antibodies, proteins, vaccines and mRNA at Hopkinton, MA, and formulation development and sterile fill-finish (liquid and lyophilized) for biologics and small molecules at Camarillo, CA, Glasgow and, for commercial supply, Albuquerque, NM. It also runs small-molecule services outside this profile. It was formerly AMRI.
- Services
- Analytical development and QC testing · Cell line development · Formulation development · GMP drug product manufacturing · GMP drug substance manufacturing · Lyophilization · Process development · Stability studies · Technology transfer
- Specialties
- Single-use bioreactors · Monoclonal antibodies · mRNA and nucleic acids · Recombinant proteins
- Locations
- Europe · North America
View profileSources reviewed November 4, 2026
Enzene
enzene.com
Enzene describes cell line, process and formulation development and GMP drug substance manufacturing of monoclonal antibodies and other recombinant proteins from mammalian (CHO) and microbial (E. coli) systems, in fed-batch or continuous mode, with in-house fill and finish of vials, prefilled syringes and cartridges. It lists manufacturing in Chakan (Pune), India, a corporate office in Pune and a New Jersey site.
- Services
- Cell line development · Formulation development · GMP drug product manufacturing · GMP drug substance manufacturing · Lyophilization · Process development · Stability studies
- Specialties
- Mammalian cell culture · Microbial fermentation · Single-use bioreactors · Monoclonal antibodies
- Locations
- Asia-Pacific · North America
View profileSources reviewed November 3, 2026
FUJIFILM Biotechnologies
fujifilmbiotechnologies.fujifilm.com
FUJIFILM Biotechnologies documents cell line, process, analytical and formulation development and cGMP drug substance and aseptic drug product manufacturing using mammalian (CHO) and microbial systems, plus viral vector and cell therapy manufacturing, from Phase I to commercial supply. It lists manufacturing sites in North Carolina, Texas and California (US), Hillerød (Denmark) and Teesside (UK).
- Services
- Analytical development and QC testing · Cell line development · Formulation development · GMP drug product manufacturing · GMP drug substance manufacturing · Highly potent APIs · Process development · Stability studies
- Specialties
- Mammalian cell culture · Microbial fermentation · Single-use bioreactors · Cell therapies
- Locations
- Asia-Pacific · Europe · North America
View profileSources reviewed November 4, 2026
Just – Evotec Biologics
evotec.com · Part of Evotec SE
Just – Evotec Biologics describes cell line (J.CHO), process, analytical and formulation development and continuous cGMP drug substance manufacturing of monoclonal, bispecific and Fc-fusion antibodies in single-use bioreactors, from first-in-human to commercial supply; drug product is not documented. It lists sites in Seattle and Redmond, Washington, and states it is a subsidiary of Evotec SE.
- Services
- Analytical development and QC testing · Cell line development · Formulation development · GMP drug substance manufacturing · Process development · Stability studies
- Specialties
- Mammalian cell culture · Single-use bioreactors · Monoclonal antibodies · Recombinant proteins
- Locations
- North America
View profileSources reviewed November 3, 2026
KBI Biopharma
kbibiopharma.com · Part of JSR Life Sciences
KBI Biopharma documents cell line development, process, analytical and formulation development, and cGMP drug substance manufacturing for biologics from first-in-human to commercial supply. It lists mammalian (CHO, single-use) manufacturing in Durham, NC, microbial (E. coli) manufacturing in Boulder, CO, and laboratories in Louisville, CO and Geneva, Switzerland. It names JSR Life Sciences as its parent company.
- Services
- Analytical development and QC testing · Cell line development · Formulation development · GMP drug substance manufacturing · Lyophilization · Process development · Stability studies · Technology transfer
- Specialties
- Mammalian cell culture · Microbial fermentation · Single-use bioreactors · Monoclonal antibodies
- Locations
- Europe · North America
View profileSources reviewed November 3, 2026
Kemwell Biopharma
kemwellbiopharma.com
Kemwell Biopharma describes cell line, process, analytical and formulation development and cGMP drug substance and drug product manufacturing (liquid and lyophilized vials, prefilled syringes) for mammalian cell culture proteins, including monoclonal antibodies, fusion proteins and bispecifics, with Phase III and commercial supply. It lists its headquarters and facilities in Bengaluru, India.
- Services
- Analytical development and QC testing · Cell line development · Formulation development · GMP drug product manufacturing · GMP drug substance manufacturing · Lyophilization · Process development · Stability studies · Technology transfer
- Specialties
- Mammalian cell culture · Single-use bioreactors · Monoclonal antibodies · Recombinant proteins
- Locations
- Asia-Pacific
View profileSources reviewed November 3, 2026
Mabion
mabion.eu
Mabion describes cell line, process and analytical method development and clinical and commercial drug substance manufacturing of monoclonal antibodies and other therapeutic proteins using mammalian (CHO) and insect cell lines in single-use bioreactors. Drug product manufacturing is not documented on current pages. It lists its headquarters in Konstantynów Łódzki, Poland.
- Services
- Analytical development and QC testing · Cell line development · GMP drug substance manufacturing · Process development · Stability studies · Technology transfer
- Specialties
- Mammalian cell culture · Single-use bioreactors · Monoclonal antibodies · Recombinant proteins
- Locations
- Europe
View profileSources reviewed November 3, 2026
Northway Biotech
northwaybiotech.com
Northway Biotech describes cell line and strain, process, analytical and formulation development and cGMP drug substance and drug product (fill and finish) manufacturing of antibodies and recombinant proteins from mammalian and microbial systems, plus plasmid DNA, viral vectors and cell therapies, for clinical and commercial supply. It lists biologics sites in Vilnius, Lithuania and Waltham, Massachusetts.
- Services
- Analytical development and QC testing · Cell line development · Formulation development · GMP drug product manufacturing · GMP drug substance manufacturing · Lyophilization · Process development · Stability studies · Technology transfer
- Specialties
- Mammalian cell culture · Microbial fermentation · Single-use bioreactors · Cell therapies
- Locations
- Europe · North America
View profileSources reviewed November 4, 2026
ProBioGen
probiogen.de
ProBioGen documents CHO and HEK293 cell line development, process, analytical and formulation development, and GMP drug substance manufacturing of antibodies and recombinant proteins in single-use bioreactors up to 1000L for preclinical and clinical supply. It also describes process development and GMP manufacturing of viral vectors and vaccines, including in-house vial filling. It is based in Berlin, Germany.
- Services
- Analytical development and QC testing · Cell line development · Formulation development · GMP drug product manufacturing · GMP drug substance manufacturing · Process development · Stability studies · Technology transfer
- Specialties
- Mammalian cell culture · Single-use bioreactors · Gene therapies · Monoclonal antibodies
- Locations
- Europe
View profileSources reviewed November 4, 2026
Rentschler Biopharma
rentschler-biopharma.com
Rentschler Biopharma describes cell line development, process, analytical and formulation development, and cGMP drug substance manufacturing of recombinant proteins and monoclonal antibodies for clinical and commercial supply. It lists headquarters and manufacturing in Laupheim, Germany, and a manufacturing site in Milford, MA, USA with single-use bioreactors.
- Services
- Analytical development and QC testing · Cell line development · Formulation development · GMP drug substance manufacturing · Process development · Technology transfer
- Specialties
- Mammalian cell culture · Single-use bioreactors · Monoclonal antibodies · Recombinant proteins
- Locations
- Europe · North America
View profileSources reviewed November 4, 2026
Resilience
resilience.com
Resilience (National Resilience) describes cell line, process, analytical and formulation development, mammalian drug substance manufacturing of monoclonal antibodies and recombinant proteins in single-use bioreactors, and sterile fill/finish, from preclinical to commercial supply. It lists headquarters in Blue Ash, Ohio, drug substance and vial filling near Toronto, and drug product at West Chester, Ohio.
- Services
- Analytical development and QC testing · Bioconjugation (ADC) · Cell line development · Formulation development · GMP drug product manufacturing · GMP drug substance manufacturing · Process development · Stability studies · Technology transfer
- Specialties
- Mammalian cell culture · Single-use bioreactors · Monoclonal antibodies · Peptides
- Locations
- North America
View profileSources reviewed November 3, 2026
Samsung Biologics
samsungbiologics.com
Samsung Biologics documents cell line development, process, formulation and analytical development, and cGMP drug substance and aseptic fill-finish drug product manufacturing for monoclonal antibodies, recombinant proteins, mRNA and ADCs, from IND-stage to commercial supply. It lists manufacturing campuses in Songdo (Incheon, South Korea) and Rockville, Maryland, and offices in the US, Tokyo and Amsterdam.
- Services
- Analytical development and QC testing · Bioconjugation (ADC) · Cell line development · Formulation development · GMP drug product manufacturing · GMP drug substance manufacturing · Highly potent APIs · Lyophilization · Process development · Stability studies · Technology transfer
- Specialties
- Mammalian cell culture · Single-use bioreactors · Antibody-drug conjugates · Monoclonal antibodies
- Locations
- Asia-Pacific · Europe · North America
View profileSources reviewed November 3, 2026
WuXi Biologics
wuxibiologics.com
WuXi Biologics documents cell line, process, analytical and drug product development and cGMP drug substance and aseptic drug product manufacturing for antibodies and recombinant proteins using mammalian and microbial systems, from preclinical to commercial supply. It lists manufacturing sites in China (Wuxi, Shanghai, Suzhou, Hangzhou, Hebei), New Jersey, Massachusetts, Ireland, Germany and Singapore.
- Services
- Analytical development and QC testing · Cell line development · Clinical packaging and labeling · Formulation development · GMP drug product manufacturing · GMP drug substance manufacturing · Lyophilization · Process development · Stability studies · Technology transfer
- Specialties
- Mammalian cell culture · Microbial fermentation · Single-use bioreactors · Antibody-drug conjugates
- Locations
- Asia-Pacific · Europe · North America
View profileSources reviewed November 4, 2026
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