Ashley Krull, PhD
ISCT Lab Practices Committee Co-Chair
Contributing Editor, ISCT Telegraft
James Cancer Hospital Cellular Therapy Laboratory
The Ohio State University
United States
The United States Food and Drug Administration (FDA) requires that the removal and/or quantification of remaining ancillary materials be addressed in the Chemistry, Manufacturing, and Controls (CMC) section of an Investigational New Drug (IND) application. This requirement is essential as certain reagents or materials such as antibiotics used in culture media may interfere with drug product testing and/or pose a serious risk to patients. Unfortunately, many of these reagents cannot be measured directly due to cost or test method suitability. Thankfully, many investigators have shown success in demonstrating to regulators effective removal of reagents throughout the manufacturing process by citing detailed calculations in their CMC sections and providing the rationale behind the math.
However, as many a trainee will tell you, having someone say “do the math” is not entirely helpful in conceptualizing what you need to do. In response to this, this month’s LPC Snapshot provides a concrete example of the calculations that can be used to demonstrate effective removal or minimalization of reagent concentrations at key points in the manufacturing process. The Snapshot goes further, citing a real-world example of how these calculations strengthened a CMC section and allowed an expeditious response to an FDA reviewer inquiry.
Click here to view the complete LPC Snapshot slide deck for December 2025
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