Title: “Risk assessment for nitrosamine contamination in SPPS produced peptides”
Abstract:
Regulatory agencies worldwide have requested drug authorization holders to evaluate drug product and drug substances processes for the possibility of introducing nitrosamine impurities with a systematic risk assessment. Bachem assesses both our solid phase peptide synthesis (SPPS) and liquid phase peptide synthesis (LPPS) processes regarding their potential of introducing nitrosamines.
This webinar will focus on our approach to execute the risk assessment for peptides produced by SPPS. We will explain the general risk factors and present their assessment for Bachem’s SPPS-related raw materials and processes.
Speaker: Matteo Villain, Vice President CMC Development
Registration Link: https://hub.bachem.com/en-GB/bachem-360/signup
Bachem Raffle:
Enjoy the 17th Naples Workshop and win a Bachem gift bag!