Скачать или смотреть Revolutionizing Drug Production: A Shift to Continuous Manufacturing

This week, Stacey is joined by Renee Phillips to discuss the pros and cons of transitioning to a continuous manufacturing system. Batch production is time-consuming yet remains a popular and time-tested method used in the pharma industry today - but some industry leaders, along with the FDA, have taken steps toward or are now contemplating a shift to continuous manufacturing. This means all stages of drug production run through to the final product, without a stop during its production, thus shut down of equipment between “batches” is required, which eliminates downtime.  CM  saves time and reduces the likelihood of human error, but is it realistic at this point in time?

Resources for this episode:

FDA issued draft guidance, Quality Considerations for Continuous Manufacturing

Rogers, Luke & Jensen, Klavs F. (2019). Continuous manufacturing – the Green Chemistry promise?. The Royal Society of Chemistry. Green Chem., Volume 21, 3481-3498.

Moore, Christine M. V., Garcia, Thomas P., Hausner, Douglas B., Ben-Anat, Inna. (2019) Holistic Control Strategies for Continuous Manufacturing. Pharmaceutical Engineering, May/June 2019

Srai, Jagjit Singh., Settani, Ettore., Aulakh, Parminder Kaur., Evaluating the Business Case for Continuous Manufacturing of Pharmaceuticals: A Supply Network Perspective. Continuous Pharmaceutical Processing, June 2020, 477-512

Van Arnum, Patricia. Pharma Industry Weighs in on Continuous Manufacturing. June 19, 2019

Manning, Richard., Sciacca, Rich., Continuous Manufacturing in Pharmaceuticals: Economic and Policy Issues. Bates White Economic Consulting, October 2018

About Our Guest:

Renée L. Phillips is an Associate Director of Global Regulatory Affairs at Janssen Research &  Development,  LLC,  a  pharmaceutical company of  Johnson  &  Johnson.  Renée has responsibility for Chemistry Manufacturing & Controls for API’s and marketed products. Previously she has held positions in Regulatory Affairs at Johnson & Johnson Consumer Companies,  Wyeth  Consumer  Products,  a  small start-up pharma company, and an environmental chemistry laboratory.  Renée currently serves as an adjunct professor at Temple University School of Pharmacy where she teaches courses in good manufacturing practices and global drug registration requirements. She earned her Bachelor of Science in Biochemistry from Georgian Court College and a Master of Science in Regulatory Affairs from San Diego State University.

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