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By Jianmei Kochling and Nanda Subbarao

Jianmei Kochling-finalNanda Subbarao-finalIn the development of drugs with quality, efficacy, and safety as the paramount goals, stability as one of the quality attributes is a key element. Stability has always been on the critical path for the development of biological medicine, whether biologics or vaccines. Therefore, adopting the right strategy for stability studies becomes critical for accelerating the development of innovative biologics therapies.

The regulatory guidances covering this field have not changed significantly over the past several years for large molecules. Yet the regulatory expectations have evolved due to several factors. There have been changes in expectations for protein analytical methods in general and, therefore, on the supportive stability studies, such as using up-to-date technology and sensitive methods to provide informative data. Sometimes, characterization methods are employed to assist with acquiring further information on the physical and chemical stability of large molecules. Moreover, the advent of biosimilars has led to even more changes in the methods toolbox for protein analysis in general, and the industry continues to learn about the regulatory expectations for biosimilar stability studies.

Finally, the growing global nature of product manufacturing has increased the need for effective and efficient stability studies. Understanding the foundational aspects of large molecules, along with understanding other external factors such as shipping, photostability, and temperature excursions, can help to build the drug development process to enable predictability and assurance of safety and efficacy.

The AAPS Stability Focus Group will present the workshop Analytical Challenges of Biologics Stability: From Concepts to Practices at the 2015 AAPS National Biotechnology Conference on June 6–7 in San Francisco. The workshop will cover a wide range of topics for both seasoned professionals and those making the transition from pharmaceuticals to biopharmaceuticals (biologics).

Jianmei Kochling, Ph.D., is a director of Quality Science and Analytical Technology of global industrial operations supporting commercial stage biological products at Genzyme, a Sanofi company.
Nanda Subbarao, Ph.D., is a senior consultant with the Biologics Consulting Group specializing in Analytical, Stability, CMC, and GLP/GMP Quality Systems.