One of the most compelling business reasons for integrated processing is the ability to de-risk capital investment due to a significantly more productive process that takes less space and less batches to generate clinical and commercial material. BI and Pfizer developed a fully integrated and automated process that consists of a continuous perfusion bioreactor connected to a periodic downstream system composed of two ProA columns, continuous viral inactivation (CVI), an anion exchange column, an SPTFF, and a single use container where the product is pooled for the duration of the run. The subsequent steps, viral filtration and ultrafiltration/diafiltration (UFDF) are done as batch. A thorough risk assessment was performed on the periodic process to implement a robust automation strategy and take actions upon possible failure modes. High level learnings on the risk assessment and details on how we are addressing perceived gaps will be discussed. A thorough viral clearance strategy will be presented for the cVI, AEX, and VRF steps as well as our approach for bioburden control.<br/>

Gap analysis on downstream integrated processing

2019 Spring National Meeting

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