- 3:15 PM

Process Analytical Technology (PAT): Use from Development through Implementation in the Pharmaceutical Industry

Katherine A. Bakeev1, Jun Chen1, Gregory J. Gervasio1, and Su-chin Lo2. (1) Chemical Development, GlaxoSmithKline, 709 Swedeland Rd., King of Prussia, PA 19406, (2) Glaxo Wellcome Manufacturing Pte. Ltd, 1 Pioneer Sector 1, Jurong, Singapore

In development of new chemical processes, there are many opportunities in applying various tools for process understanding and control be it the chemical reaction progression and kinetics, API crystallization, isolation and drying, etc. As industry faces increasingly aggressive development timelines, and demands higher quality products, the application of in-situ analytical tools during development becomes more widespread. Process analytical technology (PAT) is being applied earlier in the development cycle of products as its benefits in providing increased process understanding are exploited.

We will discuss some of the spectroscopic tools (UV-Vis, FTIR, NIR, Raman, headspace mass spectroscopy) that can be used to gain better insight into processes. Application of PAT early in the development process provides insights that aid in identifying critical quality attributes and process parameters, and provide a measure of process variability. Examples of how use of PAT has contributed to increased process understanding will be provided. Beyond providing process understanding, one can apply PAT to ensure real-time assurance of products and processes by implementing PAT tools on production scale.

Beyond the systematic scientific understanding that underlies the application of PAT, implementation on scale entails a multidisciplinary team to ensure success and bring value to the process. We will discuss key aspects of PAT implementation in industry for assuring product quality during the manufacturing process.

Web Page: www.idrc-chambersburg.org/shortcourse/kbakeevbio.pdf