Tue, 29 Apr, 2025
17:00 – 18:00 Europe/Zurich
Join us for our upcoming webinar, focusing on Chemistry, Manufacturing and Controls (CMC) process development and risk mitigation in the CMC pharmaceutical field.
Developing peptide and oligonucleotide APIs demands a precise balance of efficiency, quality and compliance. To meet the growing demand for high-quality APIs for both clinical and commercial purposes, Bachem has established a comprehensive CMC development concept. This approach is tailored to each product, ensuring flexibility while maintaining rigorous standards. The concept involves a thorough analysis of process-related risks and ensures full alignment with both clinical timelines and regulatory guidelines.
Don’t miss out as we share valuable insights into optimising CMC product development, characterisation, and risk management, all designed to deliver high-quality materials that meet the toughest clinical and regulatory requirements.
Speaker Bios
Daniel Kessler, PhD.
Sr. Group Leader Project Management
Daniel is holding a Diploma in Biology and a PhD in Medicinal Biochemistry. He worked for 6 years as Postdoctoral Researcher in Molecular Cell Biology and Tumor Biology before he joined Bachem in 2013. As Senior Group Leader in Global Project Management, Daniel is heading a group of six Project Managers, focusing on CMC Development of Peptide APIs. Anja Erdin completed her German State exam in food chemistry and received her official certification as Food chemist from CVUA Münster in 2001. She joined Bachem as a regulatory affairs specialist and became a group leader in 2009. As a group leader, she focused on NCE Development and assisting customers with navigating regulatory challenges throughout the lifecycle of their product.
Vera D’Aloisio, PhD.
Business Development Manager
Vera is a Business Development Manager with a Master’s in Pharmacy and a PhD focused on peptide design and development. During her PhD at Liverpool John Moores University and the University of Edinburgh, her research focused on the discovery and development of peptides as innovative treatments for migraine. Vera began her career in the CRO/CDMO industry in 2022 and joined Bachem in August 2024, where she supports European clients in developing novel peptide-based therapeutic drugs.
https://www.bachem.com/event/webinar-cmc-process-development-and-risk-mitigation/