Work Experiences

Supervision and support of CMOs and CTOs for external manufacturing and testing of therapeutic monoclonal antibodies (developed by Ganymed Pharmaceuticals). Providing support and review for regulatory documents (e.g. IMPD, IB, comparability studies).

Development of in vitro bioassays for characterisation and quality control of therapeutically active substances. Furthermore: Development of an aseptic manufacturing process for an investigational medicinal product containing cells (cells encapsulated in alginate for immunoprotection) under GMP. Scientific and regulatory documentation.

I was involved in student’s education as well as in interdisciplinary basic research projects concerning cell adhesion on micropatterned substrates.