How have advances in raw materials functionality, supply and quality affected the pharm/biopharma industry?

Jason M. LePree, PhD, Gattefossé USA, Pharmaceutical Division, Application Lab Manager: In the not too distant past, excipients were viewed as inert substances, judged mainly by their conformity to compendia.This view is not realistic. Increasingly known to the users is that excipients are actually referenced by compendia under general definitions, i.e. chemical descriptions that refer to a major component in the raw material. As a result, smaller constituents that may well contribute to the functionality of the excipient could be overlooked by the user. It is well understood that two raw materials complying with a single monograph, could have very different functionalities due to these very minor, concomitant components which are inherent to raw material source and manufacturing process.

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