The Regulatory Perspective: Analytical Expectations for Peptide Therapeutics

Regulatory authorities anticipate greater emphasis on analytical characterization at earlier stages of peptide therapeutics development. Let’s delve into recent insights from regulatory authorities in the United States and European Union concerning peptide characterization and the analytical pre-requisite across different developmental phases. Discover the applicability of ICH Q3A/B to peptides, the instances necessitating specific numerical values in specification, and the characterization methodology expected by regulators.

About the Speaker

Jamie Brugnano, Ph.D.

Director of Regulatory Affairs

Jamie joined Bachem in 2017 as Project Manager in Regulatory Affairs. In her current capacity, she guides Bachem’s clientele through CMC documentation and formulates global marketing approval strategies. Prior to Bachem, Jamie worked at Organovo, a three-dimensional bioprinting company where she worked at the bench bioprinting organs as an alternative for organ transplants. She transitioned in Regulatory Affairs while at Organovo, planning the commercialization strategy of bioprinted tissues. Jamie holds a Bachelor of Science in Biology from Harvey Mudd College and her Doctorate in Biomedical Engineering from Purdue University.

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