A Mab A Case Study In Bioprocess Development !full! Instant
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.
From the QTPP, engineers identify —the chemical, physical, or biological properties that must remain within strict limits to ensure patient safety and efficacy. For mAb A, the CQAs include: A Mab A Case Study In Bioprocess Development