CMC Process development and risk management in peptide manufacturing

By Bachem

Developing peptide and oligonucleotide active pharmaceutical ingredients (APIs) demands a precise balance of efficiency and attention to compliance. To meet the growing demand for APIs for both clinical and commercial purposes, Bachem has established a comprehensive Chemistry, Manufacturing, and Controls (CMC) development framework. This approach is tailored to each product, ensuring flexibility while maintaining rigorous quality standards. It involves a thorough analysis of process-related risks and ensures full alignment with both clinical timelines and regulatory guidelines.

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