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 and David Gemmel Senior Process Engineer at Merck |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.

Followed by David Gemmel Senior Process Engineer at Merck

David Gemmell is a Senior Process Engineer working for the Merck Cell Culture Media site in Irvine, Scotland. At University he obtained a BEng(Hons) in Chemical Engineering and an MSc in Advanced Chemical & Process Engineering. His early career was based in the Nuclear and Power Generation sectors before moving to Pharmaceutical and Life Sciences. David has been working for Merck for three years.

For two years he has been managing the Scale Up, Technology Transfer and Design & Build of the Large Scale HTST Pasteurisation Project at Irvine. As part of this role David has acted as the HTST Subject Matter Expert responsible for technical liaisons with internal and external stakeholders. As part of the HTST SME role he has coordinated the R&D package around HTST glucose and will continue developing R&D package on HTST Cell Culture Media and feeds.

Sponsored by Merck

The Life Science business of Merck, which operates as MilliporeSigma in the U.S. and Canada, has some 21,000 employees and 59 manufacturing sites worldwide, with a portfolio of more than 300,000 products focused on scientific discovery, biomanufacturing and testing services. From drug discovery and development to manufacturing and diagnostics, Merck is dedicated to solving the toughest problems in life science by collaborating with the global scientific community. Merck’s products range from lab water systems to genome-editing tools, antibodies, cell lines and end-to-end systems to manufacture drugs. Merck works closely with its customers from academia, biotech and pharma to help deliver the promise of their work better, faster and safer.


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