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, Klaus Mauch, CEO at Insilico Biotechnology AG |WATCH FOR FREE
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 an 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 practices 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 practices, 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 the Shire. He has a passion for continuous improvement with the 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, the UK, followed by MSc and Ph.D. degrees in Biochemical Engineering from the University of Birmingham, UK
Followed by Klaus Mauch, CEO at Insilico Biotechnology AG
Klaus Mauch is one of Insilico’s co-founders and became managing director in 2004 and CEO in 2006. In his previous role as CTO, he was responsible for the design and development of Insilico’s modeling and simulation platform where he established novel methods for the computer-aided construction of cellular networks. Before that, he gained extensive experience in metabolic engineering and applied systems biology as a group leader at the Institute of Biochemical Engineering, University of Stuttgart. He was awarded a Master’s degree in Chemical Engineering by the Technical University of Karlsruhe, Germany. Klaus is a member of the Advisory Board of the Division Systems Biology and Synthetic Biology of DECHEMA, a board member of the Industrial Association White Biotechnology (IWBio), and a board member of the Association of German Biotechnology Companies (VBU).
Insilico Biotechnology AG develops and delivers predictive Digital Twins to advance biopharmaceutical process development and manufacturing. Insilico Digital Twins of cell culture processes lead to superior productivity, product quality, and process robustness. Groundbreaking predictive power is achieved by exploiting process data using machine learning and models of biochemical networks. As a result, Insilico’s unique approach substantially reduces experimental effort, costs of goods, and time to market. Leading biopharmaceutical companies worldwide use Insilico Digital Twins for cell line development, media design, and process control. Founded in 2001, Insilico Biotechnology AG is a privately held company based in Stuttgart, Germany.