Pharmaceutical Technologist - January 2008 - (Page 23)

Integrating PAT with biopharmaceutical development and manufacture Biopharmaceutical process characterization is typically defined using data generated from scaled down (proven equivalent) equipment that is representative of the anticipated commercial unit operations. Establishing process robustness at laboratory scale to support process validation of biopharmaceutical production is essential. Here, we review the current state of manufacturing practice in the biopharmaceutical industry and the opportunities provided by ICH Q8, quality by design (QbD) and the design space, and review the technical challenges of utilizing PAT1 for the development of optimal biopharmaceutical processes. The potential to define QbD and its elements by incorporating experimental design, and multivariate data analysis to define design space, is discussed.2 C onventional biopharmaceutical manufacturing is typically undertaken using batch processing, with laboratory testing conducted at various stages of the production process to ensure product quality. While this has been a successful approach, significant opportunities exist to improve biopharmaceutical development, manufacturing and quality assurance (QA) through the application of innovative analytical techniques for process development, process analytics and process control.3 Interest in the application of PAT to biopharmaceutical production stems from the introduction of a Center for Drug Evaluation and Research (CDER) initiative on this theme in 2004.4 Regardless of the biopharmaceutical product, manufacturing technologies, analytical methods to assess product and impurity characterization, and methods to evaluate process robustness are generic tools to ensure product quality. Although the current guidelines and general principles concerning the relationship between operational excellence, quality by design (QbD), PAT and design of experiments (DoE) of multivariate analysis are widely understood at a high level, the practical aspects concerning how to integrate PATs with process development, biopharmaceutical scale-up and cGMP manufacture are typically delegated to the process scientists and, as such, the technical challenges and difficulties are often overlooked.5 Biopharmaceutical development of drug products should be designed to meet patients’ needs and the intended product performance. Strategies for product Anthony R. Newcombe Keith Watson www.ptemagazine.com 23 http://www.ptemagazine.com

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Pharmaceutical Technologist - January 2008 Contents Editor's Comment News Morpheus Market Watch Lagging Japanese Drug R&D Croatia’s Innovation Integrating PAT with Biopharmaceutical Development and Manufacture Q&A

Pharmaceutical Technologist - January 2008

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