By Pamela Hamill, Ph.D.; Amy Glekas, Ph.D.; Greg Pirozzi, Ph.D.
Conducting stability studies is a critical aspect of the drug development process, as the information gained determines key clinical development decisions and becomes an essential component of the submission package required by regulatory authorities globally. For any biological therapy, there is a set of attributes that is critical to maintaining the product’s safety and efficacy; the purpose of stability studies is to analyze these attributes at predetermined timepoints during the study to understand how they may be impacted by storage in different environmental conditions.
With the high costs and long timelines needed to bring a drug to market, improving efficiency and reducing risk wherever possible can accelerate your product development and de-risk complex studies such as stability. Learn how consolidating stability testing with a single partner offers these benefits and more.