기업 R&D 특별세션

[S3-1] 기업 R&D 특별세션


Kevin Sharp CV
Samsung Biologics, Songdo, Korea
Samsung Biologics Introduction: World Leading Biologics Contract Manufacturer

Samsung Biologics is a fully integrated Contract Development and Manufacturing Organization (CDMO) offering state-of-the-art contract development, manufacturing, and laboratory testing services. With a flawless regulatory approvals record, the largest capacity at a single site, and the fastest throughput, Samsung Biologics is an award-winning partner of choice and is uniquely able to support the development and manufacturing of biologics products at every stage of the process while meeting the evolving needs of biopharmaceutical companies worldwide.

Keywords
Samsung Biologics, biologics, manufacturing, development, CMO, CDMO



Yong Jae Kim CV
R&D Center, GC Pharma, Korea

Quality by Design characterization of the perfusion culture process for recombinant FVIII

A Quality by Design (QbD) concept was applied to characterize a cell culture process for production of the recombinant Factor VIII (rFVIII). We characterized the production bioreactor process and defined the design space by applying risk assessment to determine potential critical process parameters (CPPs) impacting critical quality attributes (CQAs). Characterization studies were subsequently performed using a qualified scaled-down model (SDM) and a multi-factorial design of experiment (DOE) approach to determine both the individual and combined impacts of the potential CPPs on CQAs. Among the operating parameters characterized, production temperature, production pH and a timing of production shift affected yield (rFVIII activity) and tyrosine sulfation level. Finally, I identified CPPs and established a design space for the cell culture process to identify appropriate conditions for routine manufacturing.

References
A Quality by Design (QbD) concept was applied to characterize a cell culture process for production of the recombinant Factor VIII (rFVIII). We characterized the production bioreactor process and defined the design space by applying risk assessment to determine potential critical process parameters (CPPs) impacting critical quality attributes (CQAs). Characterization studies were subsequently performed using a qualified scaled-down model (SDM) and a multi-factorial design of experiment (DOE) approach to determine both the individual and combined impacts of the potential CPPs on CQAs. Among the operating parameters characterized, production temperature, production pH and a timing of production shift affected yield (rFVIII activity) and tyrosine sulfation level. Finally, I identified CPPs and established a design space for the cell culture process to identify appropriate conditions for routine manufacturing.

Keywords
Quality By Design (QbD), Process characterization, Design space, Perfusion culture, Recombinant Factor VIII
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