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

Viral contamination from upstream raw material components can wreak havoc on pharmaceutical manufacturing processes, ultimately affecting cell performance and final product quality. To adequately address contamination issues, manufacturing processes typically must be halted for full site decontamination which can take several months and potentially result in a drug shortage [1, 2, 3, 4]. Biogen has taken a risk-based approach to upstream raw material contamination by elimination of animal-sourced raw materials, by identifying higher risk material and using proven viral mitigation methods that minimize detriment to raw material performance. Outsourcing of these raw material viral mitigation methods to raw material suppliers with expertise in the field has allowed for quick transition to raw materials that provide lower risk to the manufacturing process.

This talk will focus on the risk based approach that Biogen used for determining which raw materials to initially include in its upstream raw material viral risk mitigation portfolio. High Temperature Short Time (HTST) at raw material suppliers is an integral part of this risk mitigation approach. The merits of a risk-based approach to upstream viral safety will be explored, highlighting the HTST pasteurization viral mitigation capability suppliers like Merck have introduced and expanded. Treatment parameters have been detailed in publically available peer reviewed literature and confirmed in specific raw material components prior to implementation in commercial manufacturing processes. Additionally, benefits of decoupling materials with high risk of viral contamination will be reviewed.

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 Implementation of a Robust Upstream Viral Mitigation Strategy for Cell Culture Feeds

Biopharmaceutical manufacturing processes involve a multilayered approach to microbial and virus safety to assure that the drug product is safe for human use. Protection of the bioreactor comprises careful selection and screening of raw materials, comprehensive bioburden control strategies, sterile and possibly virus filtration of cell culture media and components, and the implementation of virus inactivation technologies.

High temperature short time (HTST) pasteurization is a highly effective method to achieve virus inactivation. This technology has been typically used as an in-house pretreatment tool for high risk bioreactor feeds. The availability of HTST-pretreated feeds minimizes the need to install complex and costly systems in the bioproduction facility, which have significant capital expenditure costs and can become a process bottleneck. The availability and use of complementary virus mitigation strategies minimizes the risk of introducing adventitious agents into the bioreactor, which can impact manufacturing operations and ultimately affect drug supply to patients.

The webinar details the products and capabilities Merck have developed regarding viral removal utilizing viral filtration or viral inactivation via High Temperature Short Time pasteurization, of high-risk raw material feeds for the biopharmaceutical industries.

Presented by David Gemmel Senior Process Engineer at Merck

David Gemmell is a Senior Process Engineer working within the Merck Cell Culture Media Centre of Excellence in Irvine, Scotland. At University David 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 into biopharmaceutical and life sciences. David has been working for Merck for over four years. David’s primary role entails managing long term engineering projects or driving process optimisation and process development.

For the last three years he has been managing the scale up, technology transfer, design & build of the Large-Scale High Temperature Short Time (HTST) Pasteurisation Project at Irvine. As part of this role David has acted as the HTST Subject Matter Expert (SME) responsible for technical liaisons with internal and external stakeholders and the generation of technical literature. David has driven the development of the HTST capabilities and coordinated the R&D package around HTST viral inactivation of glucose and will continue to support further research projects regarding HTST viral inactivation.

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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