CMC Biologics – Copenhagen Manufacturing Capacity Cell Culture Facilities
  • cGMP cell banking and culture expansion facilities
  • Four cell culture development laboratories designed as clean rooms and with a
    development capacity of
    • 1 x 15L and 9 x 5L bioreactors, 8 x 1L Das Gip (fed-batch and perfusion options)
  • 100L cell culture pilot plant (non-cGMP)
    • 100L and 20 L cell culture
  • 100L cGMP manufacturing line
    • Batch, fed-batch, and continuous operation
    • Fill-and-draw, internal & external spin filter, BioSep, and ATF technology
    • Perfusion capacity up to 200L/day
  • 100L cGMP manufacturing line with option for 330L cGMP manufacturing line III (330L operational by Q1 2009)
    • Batch, fed-batch, and continuous operation
    • Fill-and-draw, internal & external spin filter, BioSep, and ATF technology
    • Perfusion capacity up to 300L/day
  • cGMP manufacturing line with two 750L bioreactors
    • Batch, fed-batch, and continuous operation
    • Fill-and-draw, internal & external spin filter, and ATF technology
    • Perfusion capacity up to 1000L/day
    • Manufacture of 1500L batches (combined 750L bioreactors)

The facilities are purpose built for multi-product contract manufacturing with specific focus on flexibility, segregation, and traceability. They are also designed for future expansion to an increased manufacturing capacity.