Fraunhofer Institute for Cell Therapy and Immunology IZIGMP Biopharmaceuticals
- 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