Copenhagen Facilities

 

European Manufacturing Capacity

With state of the art clinical and commercial manufacturing facilities across the United States, Europe and Asia, AGC Biologics has the capacity and flexibility to meet each customer’s individual manufacturing needs. Our manufacturing facilities are multi-process, engineered for unidirectional flow and are segregated to allow production of multiple products at different stages of manufacturing in multiple parts of the facility. This increases the flexibility and number of manufacturing solutions available to meet clients’ rigorous manufacturing and quality needs. Right. On Time.

 

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  • Copenhagen Facility
  • Micro Recovery
  • Copenhagen Facility
  • Copenhagen Facility
  • Copenhagen Facility
  • Copenhagen Facility
  • Copenhagen Facility
  • Copenhagen Facility
  • Copenhagen Facility

COPENHAGEN FACILITIES

AGC Biologics operates multiple cGMP manufacturing lines and a variety of scales in our Copenhagen, Denmark cell culture facility. The uni-flow design allows for capacity and technological flexibility, including extensive adoption of single-use systems, while ensuring compliance with current guidelines required for cGMP compliance. Whatever the challenge, AGC Biologics is your solution for clinical and commercial manufacturing.

 

Microbial Facility Equipment

100L FERMENTATION PILOT PLANT (NON-cGMP)

  • 100L fermentation

cGMP MANUFACTURING

  • 2 x 1500L fermenters
  • Batch and fed-batch
  • Methanol feeding
  • Oxygen enrichment
  • Secreted products and inclusion bodies
  • Protein folding
  • Dedicated downstream suite
  • Experience with E. coli, yeast and other microbial systems
Cell Culture Facility Equipment

CELL BANKING AND STORAGE FACILITIES

CELL CULTURE PILOT PLANT (NON-cGMP)

  • 100L cell culture bioreactor
  • 20L cell culture bioreactor

FOUR MAMMALIAN CELL CULTURE PRODUCTION SUITES

  • Stainless steel and single-use bioreactor suite
    •  750L stainless steel
    • 500L single-use bioreactor (fed batch or ATF perfusion)
    • 2000L single-use bioreactor
  • Bioreactor 6PackTM line(available Q4 2018)
    • 6 x 2000L single-use production bioreactors
    • Production scales from 2000L to 12000L as a single run
    • Can be run in a single unit or in groups, simultaneously, sequentially or staggered --  to meet your production needs
  • Dedicated perfusion suite
    • Dedicated downstream suite
  • Single-use suite
    • 2 x 500L single use bioreactors
    • Dedicated downstream suite

PERFUSION CAPABILITIES

  • Experience with ATF, BiosepTM, internal and external spin filters and fill and draw
  • Production or N-1 perfusion
  • Perfusion rates at multiple v/v/d
  • Flexible capture and downstream capabilities