Next Generation Bioprocess Facility Design – A Case Study From Samsung Biologics
26th October 2020 | 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 and John Bonham-Carter. Product Line Leader, Cell Culture & Clarification Business, Repligen |WATCH FOR FREE
A case study be presented describing initiatives and bioprocessing approaches to maximize capacity utilization within a new large scale (12x 15kL) drug substance biologics manufacturing facility at Samsung Biologics. Facility design, manufacturing and validation strategies utilizing two harvest and purification suites with regards to cadence and product changeover (PCO) will be discussed and an overview of Samsung’s experience with advanced technologies, including (N-1) perfusion, application of single use technologies will be presented. The webinar will also describe how activities are coordinated to ensure successful tech transfers to support clinical and commercial programs, including facility fit and gap assessments to ensure manufacturing processes are adequately transferred to support successful cGMP manufacture of biologics.
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.
Followed by John Bonham-Carter. Product Line Leader, Cell Culture & Clarification Business, Repligen
John joined Repligen during 2014 as part of the acquisition of Refine Technology where he was Vice President. He has developed and worked with different upstream technologies and, most recently, has propelled the XCell™ ATF System to become the dominant industry technology in continuous culture. Previously, he has founded or co-founded multiple companies in several countries in industries from newspapers to bioprocessing. John advises and speaks on small business coaching and entrepreneurship. John is a regular international speaker on bioprocessing. He is the editor of two editions of a book introducing Continuous Bioprocessing.
Sponsored by Repligen
Inspiring advances in bioprocessing, Repligen is a technology leader in bioprocess filtration, pre-packed chromatography and Protein A ligands development. Propelled by a culture of innovation and collaboration, and with a focus on cost and process efficiencies, our people and our technologies help meet critical bioproduction demands worldwide. Named one of the fastest growing biotech companies in the USA, Repligen is headquartered in Boston, MA with major manufacturing sites in Massachusetts, California, Sweden, and Germany.