As QbD concepts applied to biotechnology products becomes more well-defined and accepted by regulators, more of the approaches are being integrated into routine process development activities across the development timeline of a product. This talk presents a case study that demonstrate how QbD principles can be effectively utilized to desire an efficient downstream process for manufacturing a therapeutic biosimilar. First, critical quality attributes of the product were identified. Next, a set of eleven analytical methods were developed. A high throughput process development (HTPD) platform was created thereafter to allow for efficient examination of different chromatography resins of each modality. Finally, process integration was performed and the resulting material compared to commercially available products. It was demonstrated that use of QbD can result in efficient and robust processes.

Implementation of QbD for development of a downstream process for a therapeutic biosimilar

253rd National Meeting (2017)

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