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 and Herman He, Senior Applications Scientist at Thermo Fisher Scientific |WATCH FOR FREE

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.
Followed by Herman He, Senior Applications Scientist at Thermo Fisher Scientific

Dr. Herman He obtained his Ph.D. in Chemical Engineering from the University of Maryland. Herman has over 20 years of experience in the field of near-infrared spectroscopy. Currently, he is a senior application scientist at Thermo Fisher Scientific. He has developed various NIR applications for QC and in-process monitoring for the pharmaceutical, chemical and food industries.
Sponsored by Thermo Fisher Scientific 

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.

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