***** ***** provides counselling to Biotech Companies and Pharma in Chemistry Manufacturing and Control of Biologics, such as protein and peptideds, made for preclinical and clinical trials. ***** (Chemistry Manufacturing and Control) Consultant with PhD in Biochemistry and 10 years of experience as Project Manager, ***** Director, Scientist and Vice President in the Biotech field. Developed recombinantly expressed proteins and peptides, and synthetic peptides, for preclinical and clinical trials. As Project Manager and head of Protein Chemistry R&D department managed and prepared therapeutic vaccine projects according to FDA and EMEA requirements. The biologics have primarily been one or two vial injectables; liquid, freeze dried or formulated peptides, polypeptides or conformational proteins, in combinations with adjuvants.
Full knowledge and expertise of cGMP production including selection and collaboration with CMO’s and CL, risk assessment, development and upscaling of downstream processes to GMP production, development and qualification of analytical methods, characterization, design of Specifications and Stability programs for DS and DP according to ICH guidelines, upscaling and technological transfer to CL and CMO’s of USP, DSP, analytical packages, formulation and filling of DP, stability studies etc. Experience includes preparing technical documentation for clinical trial applications such as IND and IMPD.
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