Controlling Peptide-Related Impurities & Meeting Regulatory Thresholds

2:00 pm - Thursday 3rd December 2026

  • Understand why peptide-related impurities have different toxicological profiles than small molecule impurities and learn strategies for negotiating appropriate impurity thresholds with regulatory agencies.
  • Discover analytical methods for identifying and quantifying peptide impurities below 0.1% and master approaches for moving from preparative HPLC to crystallisation for impurity removal.
  • Gain insights into when peptide fragments qualify as regulatory starting materials.

Speakers:

Associate Director, Analytical Science CMC
Bicycle Therapeutics plc