Bachemウェビナー "Risk assessment for a nitrosamine contamination of peptide APIs manufactured by SPPS"

【開催日時】　2022年6月30日（木） 0:30～1:30（60分間）

【参加費】　　無料（事前登録制）

【受講方法】　オンライン
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【About the Event】
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.

SPEAKERS
Matteo Villain
Vice President, CMC Development, Bachem America

MODERATOR
Lael Cheung
Business Development Manager, Bachem America

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