09.27.22 -- Tools & Techniques For Biopharma Root Cause Analysis

In biopharma, we must provide a complete and thorough record of our thought processes in order to allow a third party to understand how we have arrived at the root cause of a given problem. This article follows a mock case study to demonstrate a progression of tools and techniques to use.

Peptides are an important class of molecules placed between small molecules and biomolecules. Synthetic peptide-related impurities can originate from raw materials, manufacturing processes, degradation, and other causes. This article shares perspectives and recommendations discussed at USP's recent 2022 workshop on the topic.