By Undey, Cenk
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Additional resources for PAT Applied in Biopharmaceutical Process Development And Manufacturing : An Enabling Tool for Quality-by-Design
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4. Optimize. Continuously improve process understanding by monitoring process performance over time and comparing it with design objectives; utilize improved understanding to optimize process operation to ensure consistent attainment of approval specifications for the CQAs. Before discussing how these tasks should be accomplished in practice, it is important to place all four of them within the context of the spirit of and organizing principles behind PAT. For the products of any manufacturing process to meet predefined quality specifications consistently, there must be a comprehensive measurement system in place for acquiring appropriate measurements of key process variables and of raw materials; there must also be a reliable system determining critical quality and performance attributes of end products sufficiently frequently.
The potential benefits are great, for example, real-time release testing leading to a reduction in end-product release testing. Real-time release testing refers to the ability to evaluate and ensure the acceptable quality of in-process and/or final product based on process data. PAT could also result in elimination of superfluous monitoring and control at the manufacturing scale (Dean and Bruttin 2000). 4 conclusIons The complicated nature of biotech products makes understanding and controlling their production process not just necessary but often times difficult.
A post-production, off-line quality control strategy makes biopharmaceutical manufacturing processes extremely inefficient because the only reasonable course of action when a CQA is found to be out of range is to discard the entire product batch (due to regulatory concerns). Thus, even when the design space has been properly established, meeting CQA specifications consistently (and efficiently) with current industrial quality control procedures remains a major challenge. On-line product quality control, which has been a standard in the petroleum and chemical process industries for decades (Schuyten 1967; Ogunnaike 1994), significantly improves process efficiency because it makes “in-production” corrections possible, thereby preventing out-of-specification conditions from persisting during production.