Janssen’s Real Time release: Using MSPC to enhance batch release.


15th September 2021 | 10:00am EST | Sarah Nielsen, Director of Process Science at Janssen |BOOK FREE SEAT FOR THIS WEBINAR

The Janssen real time release strategy will be presented. Multivariate statistical process modeling is used as a way to guide batch release (either via RTR or conventional testing). The RTR strategy uses spectroscopic release tests, skip lot testing, and a surrogate model for dissolution. The surrogate dissolution model was developed with a dedicated pilot scale DOE and validated with a commercially manufactured product. Multivariate raw material and process “health check” models ensure that the surrogate dissolution model is used appropriately.  RTRT provides greater manufacturing efficiency, process monitoring and allows for additional sampling when compared to a traditional release strategy. The presentation will illustrate the commercial use of this technology for a batch manufactured product within Janssen

Presented by Sarah Nielsen, Director of Process Science at Janssen

Sarah Nielsen is a Director of Process Science within Janssen Supply Chain leading Small Molecule Integrated Quality and Supply Chain Analytics.  Sarah obtained her bachelor’s degree from the University of California- Irvine in Chemistry.  She then obtained her PhD from the University of Washington Seattle in Analytical Chemistry.  She started working at Cordis Corporation (a Johnson & Johnson Company) as a post-doctoral Fellow studying immune compatibility of cardiovascular heart stents.  She joined the pharmaceutical division of J&J (Janssen) in 2013.  Sarah leads a global team responsible for developing and implementing commercial real time release.  In addition, the team is responsible for developing a global digital quality strategy, and digital lifecycle management of pharmaceutical products.  This strategy utilizes data analytics, sensors, and mathematical modeling to provide assurance of product quality in real time.  Sarah enjoys finding ways to innovate and provide a stable, and agile supply chain to ultimately benefits our patients and customers.


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