Don't Skip Preformulation: Your Blueprint For Drug Development Success

Preformulation is an essential step during the drug product lifecycle. During this time, sponsors should gather the necessary data to inform decisions about product design and development that ultimately improve the potential for commercial success. However, this process presents challenges as sponsors are required to build a comprehensive set of evidence demonstrating the safety, purity, efficacy, manufacturability, stability, and control strategy of a drug product as quickly and inexpensively as possible.

Investing in the right preformulation studies and gathering the evidence to inform decisions is critical to identify product dead-ends and failure modes without the pain of hindsight. Societal™ CDMO's Chief Scientific Officer, Richard Sidwell, Ph.D., discusses the importance of preformulation, and why it deserves your attention.