Bachem webinar returns to NDSRI contamination measures

Bubendorf, Switzerland: – Bachem, the leading CDMO for peptides and oligonucleotides manufacturing, is hosting a further webinar on the urgent industry topic of risks of Nitrosamine contamination of peptides.

Next month’s webinar will focus on latest concerns about on nitrosamine drug substance related impurities (NDSRIs) and the gatekeeper responsibilities of CDMOs to eliminate contamination risks.

Reducing NDSRI risks

The one-hour free-to-register Bachem webinar ‘How to assess and reduce Nitrosamine Contamination Risks in Peptide APIs’ will be hosted on the Zoom channel on September 24, 2024, commencing at 1700 hrs CEST (UTC +2).

The discussion will examine the potential impacts of nitrosamine peptide-derived API contaminations, with recent years having seen several drug recalls due to NDSRIs and increased advice from medical agencies for API manufacturers to implement more stringent risk assessment and mitigation strategies to meet safety and regulatory requirements.

The webinar follows up on an earlier session hosted in June 2022 that covered  Bachem’s own methodologies for risk assessing solid phase peptide synthesis (SPPS) and liquid phase peptide synthesis (LPPS) processes to safeguard against any  potential to introduce nitrosamines.

Expert speakers

The webinar will be presented by Bachem’s Director of R&D, Dr. Laurin Melzig, and Sales Manager Generics Kira Mounier. They will focus on the gatekeeper role of a responsible CDMO like Bachem to eliminate risks of potential nitrosamine contamination between starting materials and drug formulation. They will also show how Bachem has taken measures not only to satisfy the strictest regulatory requirements but ensure the absolute quality of its peptides.

Dr. Melzig gained his PhD in organometallic chemistry in 2011, followed by PostDoc in medicinal chemistry at the Istituto Italiano di Tecnologia, Genova, before joining Bachem in 2014, where he has been in post as Director R&D and Process Development since 2022.

Ms. Mounier gained a Masters in pharmaceutical science from the University of Basel and extensive experience as a pharma consultant before joining Bachem in 2021 as Sales and Business Development Manager for generic peptides. Her current focus is on making complex generic peptide drugs  market-ready following expiry of patent.

Registration for the webinar is free of charge and can be completed online (see Resources).

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.

For further information, see www.bachem.com

Resources

Click on Bachem Webinar: How to assess and reduce Nitrosamine Contamination Risks in Peptide APIs for further details and online registration (Zoom).
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