Quality By Design: The Importance Of Reference Standards In Drug Development

By Heather Caveny, Alcami

Reference standard materials constitute an indispensable component of drug development and commercial testing. Rigorously characterized and meticulously maintained, these materials are imperative for ensuring the quality, reliability, and regulatory compliance of analytical data. While compendial products leverage established reference standards, the absence of such materials for novel chemical or biological entities presents unique challenges.

In this white paper, we delve into the importance of reference standards throughout the drug development lifecycle, from early-phase qualification to late-phase and commercial characterization. We underscore the critical role of robust management practices in safeguarding the integrity of these materials and achieving optimal analytical results.

Learn more about the comprehensive lifecycle management of reference standards, encompassing qualification, characterization, and storage procedures.