A risk-based blueprint for process control of continuous bioprocessing

Phase one: Generic risk assessment and establishing process control parameters

This paper  A risk-based blueprint for process control of continuous bioprocessing: Phase1: Establish process control parameters, gives an overview of an accompanying risk assessment template. As well as supporting the 2019 continuous bioprocessing roadmap, the  paper acts as a blueprint for industry. It will be useful for any organization new to continuous bioprocessing, while experienced companies can use it to benchmark their existing operations.

The blueprint will accelerate the realization of commercial continuous biomanufacturing processes and signals to regulators that this is the direction of industry travel, with a consensus view of how it should be done. Being able to reference BioPhorum’s blueprint will demonstrate to regulators that a manufacturer has followed an industry-agreed route, even if it has adapted this to suit its molecule and production process.

 The control plan will help lower the implementation barrier for starting continuous bioprocessing and provide a better understanding of its needs for end-users and potential vendors as it aligns and standardizes the industry’s validation approach. Ultimately, it will reduce the time to market for medicines, improve quality and lower costs – all of which will help patients. The Covid-19 pandemic has propelled the blueprint’s publication as it will potentially be useful for manufacturers of any complex protein, such as a viral vaccine.

The template provides a baseline for individual continuous bioprocess risk assessments, identifying process parameters and attributes that may significantly impact a continuous process. It is a significant step forward on industry’s journey towards harmonizing operational and regulatory alignment to realize routine continuous bioprocessing.

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A risk-based blueprint for process control of continuous bioprocessing- Phase 1- Generic risk assessment and establishing process control parameters January 2021.pdf
Generic risk assessment template for a continuous mAb process January 2021.xlsx
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  • Create Date 26th January 2021
  • DOI https://doi.org/10.46220/2021TR002
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