Operational Excellence in Process Development in Drug Substance Production


11th February 2021 | 12:00PM IST / 14:30PM CST / 15:30PM KST / 6:30AM GMT / 7:30AM CET | Ken Green, Ph.D, Head of Manufacturing, Science and Technology at Samsung Biologics. |BOOK FREE SEAT FOR THIS WEBINAR

This presentation will highlight Samsung Biologics (SBL) approach to align process development activities with technology transfer and cGMP manufacturing. This alignment allows for rapid technology transfer with robust and compliant manufacturing. In addition, the alignment of process development with regulatory requirements allows SBL to provide a comprehensive regulatory CMC data package including process controls, validation, product comparability and stability.

Process development at SBL is embedded within the manufacturing organization and as such colleagues have extensive understanding of at-scale equipment and manufacturing operations across all SBL facilities ranging from 1,000L to 15,000L scale. With 62 licensed products manufactured at SBL, process development colleagues have amassed a broad range of experience and best practice across diverse cell culture and purification processes.

The application of standardized process operating procedures enables process development to streamline laboratory scale models and testing to accurately predict at-scale process performance. Technology transfer accelerants include the application of standardized process platforms, manufacturing best practice and small scale laboratory/virtual models. Finally, the development of robust transactional processes for process characterization, technology transfer and process validation enables their efficient application across SBL to fully support cGMP manufacturing corresponding to the product lifecycle phase.

 

Presented by Ken Green, Ph.D, Head of Manufacturing, Science and Technology at Samsung Biologics.

Ken Green, Ph.D, is Head of Manufacturing, Science and Technology (MSAT) at Samsung Biologics. Ken has extensive experience in process development & characterization, technology transfer, validation and manufacturing and has held leadership roles in Process Development, MSAT and Technical Services with GSK, Amgen, Pfizer and Shire. He has a passion for continuous improvement with application of six and lean sigma methodologies for efficiency gains, problem solving and strategy deployment. Ken holds a degree in Microbiology from the University of Sheffield, UK, followed by MSc and PhD degrees in Biochemical Engineering from University of Birmingham, UK


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