Stability testing is an essential component of product development, conducted throughout the entire lifecycle of a biotherapeutic product. This critical process is integral to the quality target product profile, as it helps analysts understand how the critical quality attributes (CQAs) of both drug substances and products are influenced by various environmental conditions such as temperature, relative humidity (RH), light, storage, and pH. By examining these factors, stability testing ensures that biotherapeutic products maintain their efficacy, safety, and quality over time.
This webinar will provide an in-depth look at the importance of stability testing in the development of biotherapeutic products. Viewers will gain insights into the guidelines and protocols that govern stability testing, with a particular focus on the International Council for Harmonisation (ICH) guidelines. These guidelines are crucial for ensuring that stability studies are conducted in a systematic and standardized manner, meeting the regulatory requirements of agencies such as the World Health Organization (WHO) and other relevant bodies.
The presentation will begin with a brief overview of the ICH guidelines for stability testing, highlighting key aspects such as the selection of appropriate testing conditions, the design of stability studies, and the interpretation of results. Viewers will learn about the various stages of stability testing, from initial development through to post-market surveillance, and how these studies are integral to maintaining the quality and safety of biotherapeutic products.
By the end of this webinar, attendees will have a comprehensive understanding of the principles and practices of stability testing, including the regulatory frameworks that guide these studies and the analytical techniques used to evaluate product stability. This knowledge is vital for professionals involved in biotherapeutic product development, quality assurance, and regulatory affairs, equipping them with the expertise needed to ensure their products remain safe, effective, and compliant throughout their lifecycle.