The ISPE Student Chapter (SC) Munich is currently working on an industry project named "Biosafety Project" together with all other ISPE D/A/CH Student Chapters. The aim is to develop a guideline on how to define organizational and technical measures for keeping the operator and environment safe when manufacturing cell and gene therapies (CGT) - whilst fulfilling GMP requirements at the same time. In the first presentation the current work of the team regarding Biosafety requirements and implementation is presented, current obstacles are discussed, and future steps are shown. Operator Safety was one of the major goals to combine the flexibility to handle liquid and lyo products with fully isolated equipment, to guarantee the highest degree for a BSL 2 Viral Vaccine Fill and Finish Facility. The major hurdles from a project execution perspective will be presented from Bavarian Nordic/CDMO.
Senior Consultant Aseptic Processing & Containment,