Guido Seidel PhD

Guido has More than 18 years of experience in process development, production, quality control and quality assurance for biopharmaceuticals or biologics derived from mammalian or microbial expression systems. He Focus on recombinant proteins & antibodies and antibody derived molecules (e.g. Fabs, scFv), cGMP experience in large scale production; Scale up and down for upstream and downstream processes, analytical method development and validation.

He Transfer of biotech processes and methods, Multi-Product-Facility Design, Technical engineering for large scale fermentation and cell culture, manufacturing collaborations, FDA and EMA regulatory experience, IND/IMPD BLA filing processes, change control in late stage for biopharmaceuticals, Project management in late clinical phases,