Copenhagen Facilities

 

European Manufacturing Capacity

With state of the art clinical and commercial manufacturing facilities in both the United States and Europe, CMC Biologics has the capacity and flexibility to meet each customer’s individual manufacturing needs. CMC Biologics manufacturing facilities are multi-process, engineered for unilateral flow, and segregated to produce 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.

 

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

COPENHAGEN FACILITIES

CMC 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, CMC 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
  • Ability to perform solvent-based purification (e.g., HPLC)
Cell Culture Facility Equipment

CELL BANKING AND CULTURE EXPANSION FACILITIES

CELL CULTURE PILOT PLANT (NON-cGMP)

  • 100L cell culture
  • 20L cell culture

cGMP STAINLESS STEEL MANUFACTURING

  • 2 x 750L stainless steel production bioreactor
  • 100L stainless steel production bioreactor
  • Batch, fed-batch, and continuous operation
  • Fill-and-draw, internal and external spin filter, and ATF technology
  • Perfusion capacity up to 1000L/day
  • Manufacture of 1500L batches (combined 750L bioreactors)

cGMP SINGLE-USE MANUFACTURING

  • 2000L single-use production bioreactor
  • 500L single-use production bioreactor
  • 100L single-use production bioreactor
  • Batch, fed-batch, and continuous operation
  • Fill-and-draw, internal and external spin filter, BioSep,
  • and ATF technology
  • Perfusion capacity up to 200L/day

cGMP SINGLE-USE COMMERCIAL MANUFACTURING

  • Bioreactor 3Pack™ line — 3 x 2000L single-use production bioreactors
  • 1 x 2000L seed train