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By Nanda Subbarao

Nanda Subbarao-finalUnderstanding and predicting drug product stability is an essential activity in drug development. ICH Q8 (PDF) and FDA validation guidelines (PDF) require such an understanding to ensure pharmaceutical quality and enable continuous improvement. Having tools to gain such insight early in the development cycle also makes business sense as it can accelerate development, enable better product control, and avoid product failures and recalls.

This understanding and capability is becoming even more important with the increasing in-licensing of late stage compounds that require rapid pharmaceutical development. This is also true for compounds receiving expedited regulatory review and approval such as “breakthrough therapies” and other lifesaving medicines. To meet this need, predictive stability tools can quickly assess new formulations and the impact of formulation and process changes on product stability. Quality by design and other analytical method development strategies, in turn, can reduce method variability to enhance the power of these predictive modeling tools and ensure accurate and precise long-term confirmatory stability studies.

Two predictive modeling tools are the Accelerated Stability Assessment Program (ASAP) and the recent empirical modeling approaches specifically for nonlinear modeling such as dissolution and package moisture ingress studies. Combining these approaches can be even more advantageous. These tools offer early product stability assessments to quickly rank order formulations and predict product shelf life.

The workshop Accelerating Pharmaceutical Development Using Predictive Stability Approaches, to be held at the USP Meeting Center, Rockville, Md., April 4–5, 2016, addresses these topics. This day-and-a-half workshop will provide a comprehensive summary of stability modeling tools and method development strategies for small and large molecules products. The programming will aid the new and experienced pharmaceutical scientist in designing their development strategies and provide a forum to discuss these and other innovative pharmaceutical approaches with their colleagues and regulators.

Nanda Subbarao, Ph.D., is a senior consultant with the Biologics Consulting Group specializing in Analytical, Stability, CMC, and GLP/GMP Quality Systems.