BIOPHARMACEUTICAL IMPURITY ISSUES
This article was originally published in The Gold Sheet
Executive Summary
...are drawing attention in the search for a more coherent regulatory approach to the complexities involved. With significant implications for the development and clearance of both new and follow-on biotech products, FDA and industry are evaluating their experience to date to find where meaningful impurity standards and best practices may lie. At a recent “CMC strategy forum,” participants discussed the challenges of assessing and controlling the variety of process- and product-related impurities involved in developing biopharmaceuticals. [Included are presentations at the forum by FDA regulatory officials on: process-related impurities, host cell proteins, product-related impurities, and aggregates.]