With increasing demands to reduce the biotherapeutic time to clinic, process development efforts have adopted increasingly accelerated platforms. Our integrated process development approach with Selexis can deliver bulk drug substance for new biologics within 11 months from transfection. To keep up with this accelerated pace of process development a cross functional high-throughput team has been established with a core focus on high-throughput upstream, downstream, and analytical technologies. The implementation of high-throughput technologies, workflows, and procedures requires a shift in the mindset of traditional manufacturing support. Each facet presents its own unique challenges including capital investment, data management, and training. Case studies on the successful integration of high-throughput technologies at KBI to deliver rapid insight into product quality, downstream host cell protein clearance, and high molecular weight impurities clearance will be presented.<br/>

High-throughput and automated process development for accelerated biotherapeutic manufacturing

2019 Spring National Meeting

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