Webinar ‘Risk assessment for a nitrosamine contamination of peptide APIs manufactured by SPPS’

Webinar Replay

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, Ph.D.
Vice President of CMC Development, Bachem Americas, Inc.

Matteo joined Bachem in 2004 as Director of Research. During his career at Bachem Americas he covered both the position of VP of R&D responsible for process development, and VP of Manufacturing responsible for commercial production. In his current position as VP of CMC Development, he supports Bachem customers in identifying the activities assuring a successful CMC development. Matteo holds a Doctorate in Chemistry and Pharmaceutical Technology from University of Milano, School of Pharmacy.


Lael Cheung, Ph.D.
Business Development Manager, Bachem Americas, Inc.

Lael Cheung joined Bachem Americas in December 2019 as a Business Development Manager. He helps clients initiate and sustain GMP projects at various Bachem sites, focusing on peptide-related New Chemical Entities (NCEs). He obtained a BA in chemistry and biology from the University of Pennsylvania, followed by a PhD in organic chemistry from the University of California, Irvine. He is a co-author on several research publications and patents, most of which focus on bioconjugate chemistry and in vivo fluorescence imaging. Before joining Bachem, Lael worked at Bracco Research USA and LI-COR Biosciences, gaining experience in product development and market research.

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