Stephan Böhm Email & Phone Number

Schaftenau

Langkampfen, Tirol, Österreich

Schaftenau

Schaftenau, Austria

Heading the Drug Product Analytics Department responsible for the analytical development of biosimilars including method development/validation/transfer, stability studies of drug substance and drug product, extractable/leachable studies, particle identification/characterization and preparation of submission documents.

Schattenau, Austria

- Heading several development laboratories responsible for execution of method development/validation/transfer and stability studies from pilot and large scale GMP batches within biosimilar development- Implementation of a particle laboratory for sub-visible and visible particles characterization (protein particles (foreign matter) with state-of-the-art technology (sub visible range: MFI, DLS, NTA, RMM), state-of-the-art visual inspection area (standardized inspection booths, method development for visual inspection including test kits and operator qualification) and visible particle identification concept and technology (microscopy, Raman/Infrared spectroscopy, electron microscopy) to support manufacturing issues at DS and DP fill/finish sites

Kundl, Austria

Heading an analytical development laboratory responsible for method development and execution of stability studies within a biosimilar developmentProject Analyst for the analytical development of a biosimilar - representing Drug Product Analytics within the CMC team - planning of stability studies, data evaluation, shelf-life evaluation, preparation of technical reports