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Bachem webinar on reducing risk of nitrosamine contamination of SPPS-produced peptide APIs
Bubendorf, Switzerland: –Peptide technology specialist Bachem’s latest online webinar will focus on safeguarding peptide production processes against nitrosamine contaminations.
The webinar ‘Risk assessment for a nitrosamine contamination of peptide APIs manufactured by SPPS’ will be hosted online via the Zoom platform on June 30, 2022, commencing at 1730 EDT (UTC +2) and lasting approximately one hour. Registration for the event is free of charge and can be completed online (see Resources).
The webinar is in response to requests from regulatory agencies worldwide to drug authorization holders to evaluate drug product and drug substances processes with systematic risk assessments against the possibility of introducing nitrosamine impurities.
Nitrosamines are a family of carcinogenic impurities that are formed by the reaction of secondary amines, amides, carbamates, derivatives of urea with nitrite or other nitrogenous agents with the nitrogen in the +3 state. They are classified in ICH M7 Guideline as Class 1 impurities, “known mutagenic carcinogens”. Since 2018 and the recall of sartan class drugs, many regulatory agencies have sought to impose safety-based limits for N-nitrosamine impurities significantly below virtually safe dose (VSD).
Safe peptide synthesis
The session will focus on Bachem’s own methodologies which risk assess both solid phase peptide synthesis (SPPS) and liquid phase peptide synthesis (LPPS) processes to safeguard against any potential to introduce nitrosamines.
The webinar will explain general risk factors and present their assessment for Bachem’s SPPS-related raw materials and processes.
Hosted from Bachem Americas in California, the session will feature detailed presentations by Vice President for CMC Development Dr. Matteo Villain, and Business Development Manager, Dr. Lael Cheung, who helps clients initiate and sustain GMP projects at various Bachem sites, focusing on peptide-related New Chemical Entities (NCEs).
Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. With over 50 years of experience and expertise, Bachem 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. For further information, see www.bachem.com.
Click on Bachem webinar ‘Risk assessment for a nitrosamine contamination of peptide APIs manufactured by SPPS’ to register for the event.
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