Biopharmaceuticals

Production

  • Single-use concept up to 200 L batch volumes using different scaled bioreactor systems (stirred tank reactor, RM bioreactor)
  • Control, monitoring and data acquisition of processes via a SCADA software (BioPAT® MFCS/win)
  • Production and characterization of cell banks (MCB / WCB)
  • Process development and optimization including scale-up in the upstream and downstream areas
  • Manufacturing of preclinical batches and clinical investigational medicinal products
  • Aseptic filling in glass vials (formats 5, 10, 20 ml)
  • Validation of aseptic filling (media fill) according to the requirements of Annex 1, EU GMP Guidelines
  • Evidence of virus safety according to EMEA / CHMP / BWP / 398498/2005
  • Proof of the integrity of sterile filters according to Annex 1 EU GMP Guidelines