Impurities in Peptide Drug Substance and Challenges Faced during Registration (in US, EU, Brazil and China Markets) and Commercial Phase

Controlling impurities in complex drug substances is a crucial part of development and due to lack of harmonized approaches from Health authorities, the manufacturer faces many challenges in development, registration and even after commercialization. This presentation focuses on the challenges and discussion on possible ways forward. The presentation includes a discussion of the current regulatory scenario and expectations on peptide impurity control strategy and a reflection on different regional guidelines. It describes the challenges faced in impurity control of longer chain peptides, different analytical and orthogonal tools to be employed for impurity investigation and possible ways forward. An advanced case study describing the complex situation (of registration and commercial phase) and managing regulatory compliance, supply reliability and operational continuity is presented.

Presented at TIDES Asia, February 27, 2025 by Dinesh Parmar, Head of Regulatory Affairs Ambernath