Next Generation Bioprocess Facility Design – A Case Study From Samsung Biologics


26th October 2020 | 12:00PM IST / 14:30PM CST / 15:30PM KST / 7:30AM GMT / 8:30AM CET | Anthony Newcombe, Senior Director, Samsung Biologics and John Bonham-Carter. Product Line Leader, Cell Culture & Clarification Business, Repligen |BOOK FREE SEAT FOR THIS WEBINAR

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 Anthony Newcombe, Senior Director, Samsung Biologics

Anthony Newcombe, PhD, is a Senior Director of Project Management at Samsung Biologics, overseeing the tech transfer of monoclonal antibodies to commercial scale GMP production. Prior to joining Samsung Biologics, Dr. Newcombe held technical leadership positions within the industry as Head of Process & Product Validation, Global Industrial Operations, GSK Biologicals and as a member of the Technical Leadership Team at Pfizer Biotechnology Ireland. Dr. Newcombe holds a PhD in Biochemistry from the MRC National Institute for Medical Research, London, and is a Fellow of the Royal Society of Chemistry U.K. (FRSC).

 

Followed by An Industry Perspective 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.


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