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Risk Assessment for a Nitrosamine Contamination of Peptide APIs Manufactured by SPPS

This webinar will focus on Bachem's approach to execute the risk assessment for peptides produced by SPPS

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By: Tim Wright

Editor-in-Chief, Contract Pharma

June 30, 2022 – 8:30 AM PST / 5:30 PM CET

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.

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