Build A Foundation For Successful Clinical Manufacturing By Being Honest About GMP-Readiness

It can be difficult to objectively assess your GMP-readiness and know for certain when it is time to move forward to clinical manufacturing. There are concrete indicators, such as achieving the desired results from toxicology tests and animal studies, and other equally important considerations. Contract development and manufacturing organizations (CDMOs) have unique expertise in assessing GMP-readiness, and understanding what they look for will help you conduct your own assessment.

This article reviews the three Ps as a framework for setting the foundation for success as well as how to set realistic and achieve timelines, engage MS&T to move from process development to GMP . and create a dialogue that focuses on how to prepare the process for the GMP environment.