cGMP Protein Manufacturing Clean Rooms

cGMP Protein Manufacturing

 

  • Microbial infrastructure – E.Coli
  • 50 liter working volume fermenter with sterilization-in-place
  • Clean-in-place skid
  • Four ISO 7 and ISO 8 clean rooms operating at a minimum of 30 air changes per hour with single-pass HEPA-filtered air supplied by a dedicated air handling unit
 

  • Clean rooms for buffer preparation, clarification, protein purification, and aseptic formulation and fill of bulk drug substance
  • Two – 50 liter magnetic mixers for buffer preparation
  • Purification – 0.25 to 2 liter column chromatography capability in both gradient and step format and AKTA protein purification system
  • Ultra-Filtration/Tangential-Flow Filtration