Next Generation Bioprocess Facility Design - A Case Study From Samsung Biologics
Ken Green, Ph.D, Science and Technology at Samsung Biologics. John Bonham-Carter. Product Line Leader, Repligen
About this talk
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. The webinar will highlight initiatives and working practices at Samsung Biologics to ensure our biologic manufacturing operations are cost effective, flexible and responsive to the needs and demands of our clients and can adapt to a rapidly to accommodate a diverse pipeline of antibody biotherapeutics.
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