Raw Material Control For Biotechs (Part 2): Clinical Development Considerations

By Steve Kornher, Ph.D.

Welcome to part two of the Halloran Insights series on raw material control for biotechs. In part one, we emphasized the significance of establishing raw material control during the initial stages of product development. In this installment, our focus shifts to refining the raw material control strategy in anticipation of a commercial license application.

As clinical development advances, the importance of raw material control escalates, playing a pivotal role in securing licensure for therapeutic agents. While our discussion primarily revolves around cell and gene therapies (CGTs), the principles outlined herein are broadly applicable to various early-stage biological therapies. Join us as we delve deeper into strategies for enhancing raw material control to facilitate successful regulatory submissions and commercialization efforts.