How to assess and reduce Nitrosamine Contamination Risks in Peptide APIs

Recent years have seen drug recalls based on nitrosamine drug substance related impurities (NDSRIs), with medical agencies advising API manufacturers to implement risk assessment and mitigation strategies to meet safety and regulatory requirements. CDMOs often serve as a gatekeeper for potential nitrosamine contamination between starting materials and drug formulation. Join this webinar to learn how Bachem aims not only to satisfy the strictest regulatory requirements but ensures customers and patients alike can trust the quality of our peptides.

 

About the Speakers

Laurin Melzig

Director R&D

Laurin Melzig completed his graduate studies at the Ludwig Maximilian University, Munich, Germany. After his PhD Dissertation in organometallic chemistry with Prof. Knochel in 2011, he went on to do a PostDoc in medicinal chemistry at the Istituto Italiano di Tecnologia, Genova, Italy from 2011 to 2014. He then joined Bachem in 2014, where he acts as Director R&D and Process Development since 2022.

Kira Mounier

Sales Manager - Generics

Kira Mounier received a master’s degree in pharmaceutical science from the University of Basel. She gained experience in the pharmaceutical industry by consulting for a pharma and MedTech start-ups before joining Bachem in 2021 as Sales and Business Development Manager for generic peptides. Her current focus is on the sales of complex generic peptide drugs that need yet to be developed or optimized to be fit for market authorization upon patent expiry.

Webinars