At the recent conference for pharmaceutical and biotech manufacturers, Interphex 2012, Pharmaceutical Manufacturing magazine Editor in Chief Agnes Shanley discussed trends in the industry’s use of process analytical technology (PAT) and quality by design (QbD) with Emerson’s Director of Life Sciences Industry Consulting, Chris Amstutz.
Their discussion was captured in this 4:48 YouTube video, Emerson Process Management’s Chris Amstutz on PAT & QbD on the pharmabackpack YouTube channel.
Agnes opens by asking Chris about the trends with respect to PAT and QbD among pharmaceutical and biotech manufacturers. Chris notes that many of these manufacturers have moved beyond the “tire-kicking” phase to the implementation phase. Some manufacturers are turning these initiatives into full-blown programs with support throughout the organizational hierarchy. The program includes all phases from process development to technology transfer to full-scale production. It then goes full circle back to future process development initiatives.
Chris describes how robustness and availability issues are addressed by bringing PAT methods directly into the recipes. In an earlier post, Interphex 2012 – Real-Time Release in Production Recipes, I shared examples of how these PAT methods were incorporated. Towards the end of the video, Chris highlights a manufacturer who applied PAT methods around product moisture, which led to $2 million annual savings in improved product quality.
Agnes asks about the current level of interest with manufacturing execution systems (MES). Chris shares that interest is on the upswing over the past 18-24 months due to the growing view that MES is a key part of the overall data management strategy. Efficiently managing the data throughout the development and production process reduces lags in the process and increases overall profitability.
Chris has an active Life Sciences track in the Emerson Exchange 365 community where you can connect with other pharmaceutical and biotech professionals and Emerson Life Science subject matter experts.