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By: Mark Alasandro and David Lavrich

David Lavrich

Mark Alasandro

Pharmaceutical scientists are facing increasing challenges to shorten development timelines, quickly advance late-stage in-licensed compounds, and launch life-saving “breakthrough” therapies. There is also the need to enhance quality through applications of ICH Q8, FDA validation guidelines, and other related guidance’s. To meet these challenges there are a variety of tools to employ, including Design of Experiments (DOE), statistical modeling, accelerated stability studies, and QbD analytical method development approaches. Integrating these with a lean, science-based, stability approach further focuses resources to gather relevant analytical data and build efficient development strategies to enhance quality, meet global requirements, and accelerate development timelines.

An excellent application of these tools is to characterize product stability, as stability is a key critical quality attribute that is impacted by many factors – raw materials, formulation, process, packaging, distribution, etc. Statistically modeling these interactions gives insight into the manufacturing process and demonstrates product understanding. Indeed, monitoring to ensure your product stays within the model ensures continuous supply of quality product to our customers.

Case studies using these tools were showcased at the April 2016 workshop Accelerating Pharmaceutical Development Using Predictive Stability Approaches along with follow-up discussions at the Stability focus group sponsored face-to-face (F2F) meeting with the CMC Statistics and the Pharmaceutical Impurities focus groups. Topics discussed included:

  • Multivariant predictive stability modeling tools
  • Optimizing method development to enhance predictive modeling
  • Lean stability approaches and global regulatory acceptance of these approaches
  • Statistical modeling to set shelf life and justify temperature excursions
  • Dissolution modeling
  • Applications of QbD analytical method development for large molecules
  • Risk based and lifecycle strategies

Key outcomes from this workshop and the F2F meeting, along with the latest predictive stability approaches and strategies to enhance pharmaceutical quality and accelerate development, will be presented at the upcoming Enhancing Pharmaceutical Quality through Predictive Stability Approaches, on Wednesday, November 16, 2016.  The session’s focus will be on applying these tools to build an overall development strategy and apply lean science-based approaches to meet today’s challenges.

Please join us, as we believe this session will aid new and experienced pharmaceutical scientists in designing development strategies, as well as provide a forum to discuss these and other innovative pharmaceutical approaches with your colleagues.

Dr. Mark Alasandro is a Director of Analytical Development and Control at Orexigen Therapeutics.  He has led multiple research teams at Merck, BMS and Allergan in the development, validation, global methods transfers and registration of several multi-billion dollar products.
Dr. David J. Lavrich is a Senior Principal Scientist in Analytical Development and Commercialization at Merck & Co., Inc., West Point, PA.  He received a Bachelor of Science in chemistry from Juniata College in 1989, and a Ph. D. in physical chemistry from Yale University in 1995.