DS InPharmatics' Senior Drug Substance Consultant, James Mencel continues his discussion on expedited drug development programs, specifically the importance of establishing regulatory starting materials. In this episode, Ed, Meranda and James discuss how the FDA and sponsors deal with the challenges of establishing starting materials, the role of the International Council for Harmonisation (ICH) and striking the balance between appropriate regulatory control and sustainable manufacturability.
“It takes a fair bit of time to develop a package to support a regulatory starting material proposal to an agency. And the better packages are ones that are supported by data…The reason this is important is because the stronger your package is, the more likely you are to be successful in your proposal.”
“I see this as like being an advanced scout watching another team play ball. If you can stand at the field and watch how they approach and do things, you’re prepared when you face that team yourself. And I think if you can approach the FDA and say, ‘Look, here’s what we have based upon the guidance. What do you think?’ I think you’re better off than waiting until you face them now and when you have to do it because you’ve run out of time and you’re really not prepared.”
“One of the crux issues with choosing a starting material is the whole case you can make about how you purge the impurities from that point forward.”
“I think it’s [the ICH Q11] is a great document. And I think that any process chemist should read it and understand what’s being looked for.”
“What it really comes down to is you want to try to understand what’s making your process tick. If you get some new impurity, the process is telling you something. Where is it coming from? Sometimes you get impurities you can’t get rid of. How do you deal with an impurity that does not go away?”
International Council fo Harmonisation
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