An on-demand presentation by Matteo Villain, Ph.D., Vice President, CMC Development, Bachem Americas, Inc.
Over the last 50 years of API GMP manufacturing, Bachem has established standardized but modular approach to Process Design and Process Qualification of peptidic API. Internally, this approach is defined as the “CMC Concept”.
This modular approach is used to drive the selection of critical activities required to reach a successful commercial registration.
In this modular CMC Development framework, the sponsor is kept in a central position to assure meeting the sponsor needs, the different agencies expectation and requirements, but more importantly, to assure patient safety. In this context, product and process previous knowledge have a significant impact in defining the criticality of the different activities.
The case study presented will investigate the activities undertaken in agreement with the sponsor leading to a successful process validation for the product (Nle3)-Angiotensin I/II.
