A growing number of drug launches have faltered at the final hour because manufacturing processes weren’t up to FDA standards. Some went through that disappointment more than once. How can drug developers properly monitor quality throughout the clinical production process and fix any issues that arise—before the FDA brings out the red flags?
For all of their drug development brilliance, biotech founders often underestimate the essential need to have manufacturing & process development professionals whose resumes and skills match their own. As drugs are getting more complex, so is drug manufacturing, and an MPD professional not only experienced but current with evolving techniques and standards is a key investment, even if developers are using contract manufacturing.
Too often, drug developers think conversations with the FDA start when they file their application. Not so, particularly if new manufacturing methods are needed. If the process is new or complex, it is better to educate FDA reviewers in advance.
Many drug developers naturally turn to contract manufacturers, but even with the best, they need to stay deeply involved, and aware of what is happening with their CDMO. A manufacturing plant that runs into FDA concerns, even for something unrelated to your efforts, can still delay years of work and the rewards of a drug approval.
We’ll look at the diverse set of tactics companies can use to forestall manufacturing disappointments, from recruitment to partnerships to regulatory communication and more.