Nicholas Morely
Associate Director, Analytical Science CMC Bicycle Therapeutics plc
Nicholas Morley is the Associate Director of Analytical Sciences at Bicycle Therapeutics, where he leads the strategic analytical science activities required to advance innovative peptide-based medicines from candidate selection through to clinical registration and commercial launch.
He has more than two decades of experience in pharmaceutical analysis and material safety across biopharmaceuticals and contract research organisations.
Throughout his career, he has focused on the development and application of analytical strategies to ensure regulatory compliance across pharmaceutical and healthcare products. His expertise spans both early and late phase development helping to support the successful development and commercialization of drug products.
Seminars
- 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.
