Guest Column | November 15, 2021

Balancing Conservative vs. Progressive Approaches To Enable Biomanufacturing Quality By Design

By Jason Dickens and Mike Ponstingl

Data Artificial Intelligence Algorithm iStock-1295900106

As the biopharmaceutical industry continues to pursue innovations that streamline processes along the clinical and commercial development pipeline, an increasing number of biopharmaceutical manufacturers have begun to adopt continuous improvement strategies that offer them greater process control, more robust manufacturing processes, and ultimately, higher quality products.

Process Analytical Technologies (PAT), real-time analytical devices and measurement tools, can be used to continuously monitor parts of a process in order to safeguard its quality or identify areas for improvement. PAT are among several tools that can help promote greater process knowledge and enable a Quality by Design (QbD) approach, which in turn helps facilitate improved product quality and mitigate risk.

Designing a control strategy that incorporates PAT requires an understanding of how these technologies can support a sustainable and transferrable manufacturing process. This can be a daunting undertaking, particularly for biopharmaceutical companies that have relied on traditional release testing, but the potential benefits are manifold. Real-time capabilities represent the future of scale up and scale out – companies can stand up new facilities and directly compare their processes from Day 1, enabling a level of control unheard of just decades ago.

Traditionally in the bioprocessing space, the quality of an end product has been determined by post-manufacturing testing. Increasingly, biopharmaceutical companies and manufacturers have begun to incorporate QbD approaches that utilize in-line monitoring to achieve continuous process verification, process control, or real-time release. Real-time release necessitates a more conservative approach to PAT implementation, whereas process control and continuous verification may necessitate a more progressive approach.  Determining what approach to take, as well as how to tailor that approach to multiple sites and future business objectives, is critical to a process control strategy that will position a bioprocessing manufacturer for the future.

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