Integrated Approach to Semi-Continuous Biopharmaceutical Manufacturing
GlaxoSmithKline’s approach to developing a semi-continuous manufacturing platform is to maximize equipment utilization and reduce the capital investment required for future facilities, resulting in a flexible and small manufacturing platform that can support varying BDS manufacturing demands. Dr. Mehdi Ghodbane from GSK will present on three main aspects of the semi-continuous approach; facility layout and equipment design, the analytical strategy, and data management/visualization capabilities. He will explain how the technical feasibility of this manufacturing paradigm, was assessed with a ‘sandbox’ facility, and will discuss how laboratory work, technology assessments, process development, and process de-risking can occur such that technology transfer and future manufacturing operations risks can be mitigated.
Speaker:
Mehdi Ghodbane, PhD.
Scientific Leader, Biopharmaceutical Product Development & Supply at GlaxoSmithKline
Mehdi joined GSK in 2015 working with the Biopharmaceutical Advanced Manufacturing Technologies department, an organization focused solely on technology development. After working to advance various novel purification technologies, he began focusing on developing integrated drug substance manufacturing. In parallel, Mehdi has led efforts to develop unit operations suitable for integration within an intensified, continuous or semi-continuous framework. He was appointed Scientific Lead of Integrated Drug Substance Manufacture at GSK in 2020. In this position, Mehdi provides oversight and active management of the integrated downstream platform team and overall program, with a clear focus on delivering near- and long-term strategy for development of a GMP-ready downstream platform. He received his B.S. degree in Bioengineering from Lehigh University and Ph.D. in Biomedical Engineering from Rutgers University.
Registration Information:
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COST |
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|---|---|
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ISPE Members |
$25 |
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Non-Members |
$35 |
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Emerging Leaders/Student |
$15 |
| Group/Multiple Participants (in one sitting) | $50 |
**Participants can earn 1 PDH credit for attending**