The bioprocessing industry has been steadily moving toward end-to-end continuous downstream processing, with particular achievements in design and implementation of continuous chromatography and virus inactivation. However, continuous viral filtration and continuous ultrafiltration/diafiltration remains a significant gap on the path towards realization of an integrated end-to-end downstream process. Here we describe the integration of a continuous virus filtration, ultrafiltration and diafiltration, and in-line formulation for the continuous generation of drug substance. We also demonstrate a proof-of-concept of automating and controlling these unit operations from a single master controller at the pilot scale. We will then discuss the implications of this work towards commercial implementation of an integrated end-to-end continuous process, including a preliminary analysis of process economics. Our work demonstrates the feasibility of integrating continuous viral filtration and ultrafiltration/diafiltration into a pilot scale continuous downstream process and represents a significant step towards end-to-end continuous downstream processing.

Development and integration of continuous viral filtration, ultrafiltration, and diafiltration at pilot scale

2019 Spring National Meeting

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