Dr. Stefan Schleper

Lead teams in US, France and Germany as part of the Mammalian Platform within CMC. Responsible for non-GMP DS manufacturing, management of tech transfers within Sanofi and to CMOs. Support for GMP sites regarding deviations, root-cause analysis and implementation of new technologies.

Sanofi R+D Biologics Tech Transfer of cell culture projects, manufacturing support, technology evaluation, technical manufacturing, data management.

Key contact for topics around disposable/single-use technology within Sanofi R+D Biologics Guidelines on single-use technology like E+L, implementation of SUT in GMP processes, standardization and harmonization. Various collaborations with internal and external partners on single-use technologies.

Sanofi R+D Biologics Process Development of Biologics (Monoclonal Antibodies and related molecules) Process transfers intern and extern Various international working groups, e.g. QbD, new technologies, harmonization Due Dilligences

Large scale GMP manufacturing of Insulin API. Pre Approval Inspections by U.S. FDA and Canada. Process validation. Implementation of Electronic Batch Record. Implementation of PAT.

Biochemie