The project began with a typical industry hurdle: a high-titer cell line that produced significant product-related impurities
The primary goal of the A-Mab study is to move away from "quality by testing" (verifying quality at the end of the process) toward a systematic, risk-based approach where quality is built into the process from the start. A Mab A Case Study In Bioprocess Development
principles from ICH guidelines (Q8, Q9, and Q10) could be applied to the development of a monoclonal antibody (mAb). International Society for Pharmaceutical Engineering (ISPE) Key Sections and Core Principles The project began with a typical industry hurdle: