Upstream Viral Risk Mitigation Strategy for High Titer Biologics Manufacturing


17th October 2019 | 10.00 am EST | Aaron Mack, Engineer at Biogen and Dave Kolwyck, Director Materials Science at Biogen |BOOK FREE SEAT

Presented by Aaron Mack, Engineer at Biogen

Aaron Mack is an Engineer at Biogen and is responsible for providing global support and technical raw material support for Manufacturing Sciences and is focused on supplier capital projects and raw material control and monitoring strategies.

He has a B. S. in Biomedical Engineering, an M. S. in Molecular Science and Nanotechnology and has led projects in GMP manufacturing facilities at both a raw material supplier and a drug manufacturer. He joined Biogen in April 2017 and brings expertise in pharmaceutical research and engineering, with over 13 years of experience in process development and 8 years of experience in GMP manufacturing roles. He has been working with the BPOG Raw Material Variability (RMV) group since March 2018.

And Dave Kolwyck, Director Materials Science at Biogen
Dave Kolwyck is the Director of the Global Materials Science team at Biogen where his team has technical responsibility for defining critical material attributes, supplier technical assessments and operational improvement projects related to raw materials and consumables used in Biogen’s global drug substance manufacturing network. He has been involved in the manufacture, characterization and development of pharmaceutical raw materials for >15 yrs as both a supplier and end-user. Prior to Biogen, he was at Amgen as the technical lead for upstream Raw Materials used in their biologics manufacturing network. As a supply chain partner, he held a variety of technical and commercial roles at JRH and Sigma Aldrich, specific to the manufacturing of cell culture media and chemicals intended for use in pharmaceutical manufacturing. David holds a B. Sci. from Truman State University, M. Sci. from University of Iowa and a M.B.A. from Washington University, St. Louis.

 


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