Dirk Lehnert

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.

Thesis: Influence of micropatterned substrates on cell adhesion and migration.

External diploma thesis at the Institute of Brain Research (ETH/Uni) in Zürich, Switzerland. Title: „Development and Characerisation of Monoclonal Antibodies against the AMPA-Receptor-Subunit GluR1“ (Jan. 1999 - Oct. 1999)

Apprenticeship at the Suedwetdeutsche Landesbank (today: Landesbank Baden-Wuerttemberg) including special courses in the securities trade. Price winner as best apprentice.