Since the approval of the first peptide therapeutic, insulin, in 1923, the peptide market has seen exponential growth. Today, over 100 peptide drugs have been approved, with some indications, such as weight management and diabetes, requiring over 1 metric ton of peptide production annually. As the peptide market expands, the need for a comprehensive Chemistry, Manufacturing, and Controls (CMC) framework to support New Chemical Entity (NCE) development programs has become increasingly important.

Bachem CMC Framework addresses this requirement by offering an interdisciplinary approach that ensures peptide drugs meet the highest standards of quality, safety, and efficacy. Designed to be flexible and responsive to customer needs, the framework de-risks development projects through the establishment of robust manufacturing processes, meticulous analysis and characterization, and strict adherence to regulatory guidelines. This approach ensures that peptide-based therapies can be brought to market efficiently while maintaining compliance with global regulatory standards.

This talk will present Bachem CMC Concept and case studies where the Bachem CMC Framework was successfully implemented in peptide drug development programs. These case studies will highlight the key challenges encountered, the strategies employed to mitigate risks, and the ultimate outcomes of the projects. Attendees will gain valuable insights into how the CMC Framework can accelerate peptide development while ensuring that products meet stringent quality and safety standards, ultimately facilitating successful commercialization of peptide-based therapies.

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.