BIOPHARMACEUTICAL PROCESS DEVELOPMENT
The Cell Technology group offers a service of development of animal cell based processes suitable for industrial production of biopharmaceutical (e.g. antibody, glycoprotein) in e.g. CHO, HEK293 or NS0 cell-based system in preparation for clinical phase I manufacturing.
SERVICES
- Extensive experience of process development for biopharmaceutical industry, e.g. CHO, NS0, HEK293
- Development of fed-batch or perfusion process process suitable for commercial production
- Process transfer to Contract Manufacturing Organization (CMO) for GMP production, including support to pilot/commercial size
- Full documentation and traceability
- Consulting for biopharmaceutical process development and produciton
TRACK RECORDS
Since the initiation of this service facility in 2008, numerous services have been delivered by the CETEG, among other: Three fed-batch processes were developed for the production of biopharmaceutical, i.e. monoclonal antibody and glycoproteins. Two processes were successfully transferred to CMO for GMP production in view of manufacturing of clinical material. Material was manufactured for toxicological study in 4 L and 20 L sizes for two processes.
