Simone Kardinahl

Cell & Protein Sciences provides a strong R&D interface to enable successful and rapid clinical development, while laying the foundation for high performance leads with high quality antigens and screening solutions. Antibody Lead Discovery is in charge of defining and executing in Lead Finding Strategies for antibody generation projects. Phage Display as well as Immunization technologies are used and resulting antibody candidates are further optimized in terms of affinity / potency and immunogenicity.

Global Biological Development in Wuppertal (currently 121 employees) develops biologicals for different therapeutic indications. The organization consists of Upstream Development, Downstream Development incl Analytics and two Pilot Plant Facilities. Submission of a Phase II Study in the shortest possible time. Successful start up of a Cell Culture Pilot Plant. Reorganization and strategic re-alignment of the department. Successful mitigation of a Single Supply Situation.

The Microbiological Production facility performs biotransformation reactions of steroids by use of bacteria, fungi and yeast. The production is run under cGMP and in a continuous shift-system. Significant cost reduction through process and yield stabilization, technology change. Stabilization of quality through establishing of real-time in-process-monitoring. Coordination of optimization processes across plants. Alignment on leadership principles and leadership roles.

Development and transfer of fermentation and downstream processes from lab scale (10L/50L) to pilot scale (500L/ 5000L / 50.000L). Replacement of whole cell fermentation by enzyme catalysis resulting in significant cost of goods reductions. Head of Microbial Quality Control (water, drug substance) for the Bergkamen site. Team member of the change team, contributing to roll out of a „ Story of the Future” and vision as a guiding principles of the change.

Optimization of fermentation parameters to increase volumetric productivity. Screening of microbial and fungal strains incl GMOs to improve yield/quality. Improvement of drug substance synthesis by introducing enzyme catalysis thus replacing multiple chemical steps.

Optimization of a whole cell fermentation process to stereospecifically dihydroxylate a steroid substrate. Qualification of raw materials for use in GMP processes.

Purification of native antigens from different microbial, viral and human sources to enable establishment of diagnostic test systems based on antigen-antibody reactions. Successful purification of transglutaminase from human liver thus enabling establishment of a coeliac disease test system.

Summa cum laude / Universitätspreis der Universität zu Lübeck

Summa cum laude / Universitätspreis der Universität zu Lübeck