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 focuses on our approach to execute the risk assessment for peptides produced by SPPS.
We explain the general risk factors and present their assessment for Bachem’s SPPS-related raw materials and processes.
Watch the full version and all previous and future webinars in our showroom Bachem 360 Live Area:
hub.bachem.com...
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About Bachem:
Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides.
The company, which has over 50 years of experience and expertise, provides products for research, clinical development, and commercial application to pharmaceutical and biotechnology companies worldwide and offers a comprehensive range of services.
Bachem operates internationally with headquarters in Switzerland and locations in Europe, the US and Asia. The company is listed on the SIX Swiss Exchange.
Learn more about our products and services at bit.ly/3LykCeY
28 авг 2024
