Global CDMO for the development and cGMP manufacturing of Biologics and Cell and Gene Therapies
AGC Biologics
Bothell, WA (US) · Copenhagen/Søborg (DK) · Heidelberg (DE) · Chiba/Ichihara (JP) · Longmont, CO (US) · Bresso/Milan (IT)New on Amplifa
About AGC Biologics
AGC Biologics is an international Contract Development and Manufacturing Organization (CDMO) for biopharmaceuticals. The company develops and produces therapeutic proteins based on mammalian and microbial cells, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically modified cell therapies. The scope of services includes cell line development (including the CHEF1 expression system), upstream and downstream process development, analytical development, formulation development, and cGMP manufacturing, including perfusion and a scale-out manufacturing strategy using single-use bioreactors. The global network extends across the USA, Europe, and Asia with cGMP-compliant sites in Seattle/Bothell, Copenhagen, Heidelberg, Milan, and Chiba/Yokohama. Customers come from the Biopharmaceuticals, Biologics, and Cell and Gene Therapies industries; among other partnerships, there is a collaboration with Pyramid Pharma Services for finished drug fill/finish.
- Site
- Bothell, WA 98021
- Processes
- cGMP Manufacturing (Biopharmaceuticals, Biologics), Mammalian Cell Line Development, Microbial Cell Line Development, Upstream Process Development, Downstream Process Development, Analytical Development, Formulation Development, Perfusion (Bioprocess)
- Materials
- Mammalian cell-based therapeutic proteins, Microbial-based therapeutic proteins, Plasmid DNA (pDNA), Messenger RNA (mRNA), Viral vectors, Genetically engineered cell therapies, Perfusion (Bioprocess), Single-Use Bioreactors (Scale-out)
- Certificates
- cGMP-compliant manufacturing
- Employees
- 1.001–5.000 (LinkedI
- Industries
- Biopharmaceuticals, Pharmaceutical Manufacturing, Biologics, Cell & Gene Therapies
- 01
Cell line development (mammalian/microbial)
- 02
Upstream process development
- 03
Downstream process development
- 04
Analytical development
- 05
Formulation development
- 06
cGMP manufacturing (Single-Use Bioreactors, Perfusion)
- 07
Fill/Finish via partners
Product Groups and Processes
Mammalian cell-based therapeutic proteins
Development and cGMP manufacturing of therapeutic proteins from mammalian cells, including the CHEF1 expression system.
Microbial-based therapeutic proteins
Development and cGMP manufacturing of therapeutic proteins based on microbial processes.
Plasmid DNA (pDNA)
Production of Plasmid DNA as raw material for gene therapies and other applications.
Messenger RNA (mRNA)
Development and manufacturing of mRNA products.
Viral vectors
Manufacturing of viral vectors for gene therapies.
Genetically engineered cell therapies
Development and manufacturing of genetically modified cell therapies.
Perfusion (Bioprocess)
Perfusion processes for bioproduction.
Single-Use Bioreactors (Scale-out)
Flexible capacity increase through parallel single-use bioreactors instead of larger tanks.
Locations
Bothell, WA
USHeadquarters
- Materials
- mammalian and microbial therapeutic proteins, pDNA, mRNA, viral vectors, cell therapies
- Single-Use Bioreactors
Copenhagen (Søborg)
DKcGMP Manufacturing
Heidelberg
DESite
Chiba (Ichihara City)
JPcGMP Manufacturing
Longmont, CO
USSite
Bresso (Milan)
ITSite
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| cGMP Manufacturing (Biopharmaceuticals, Biologics)Assembly | – | – | – | – | mammalian cells, microbial cells, plasmid DNA (pDNA), mRNA, viral vectors, cell therapies |
| Mammalian Cell Line DevelopmentEngineering | – | – | – | – | mammalian cells |
| Microbial Cell Line DevelopmentEngineering | – | – | – | – | microbial cells |
| Upstream Process DevelopmentEngineering | – | – | – | – | – |
| Downstream Process DevelopmentEngineering | – | – | – | – | – |
| Analytical DevelopmentTesting | – | – | – | – | – |
| Formulation DevelopmentEngineering | – | – | – | – | – |
| Perfusion (Bioprocess)Assembly | – | – | – | – | – |
| Single-Use Bioreactor Scale-out ManufacturingAssembly | – | – | – | – | mammalian cells |
1 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| Single-Use Bioreactors | – | – | – | – | – |
Additional services
Reference customers
Quality
Manufacturing takes place in cGMP-compliant facilities in Seattle, Copenhagen, Heidelberg, Milan, and Chiba/Yokohama.
| Evidence | Bothell, WA | Copenhagen (Søborg) | Heidelberg | Chiba (Ichihara City) | Longmont, CO | Bresso (Milan) |
|---|---|---|---|---|---|---|
| cGMP-compliant manufacturing |