Accelerating Purification Process Development of an Early Phase MAb with High-Throughput Automation:Part 1 of a Technical Report 1

摘要

Monoclonal antibodies (MAbs) are the fastest growing segment in the biopharmaceutical industry because they are potentially efficacious in the treatment of diseases such as cancer and autoimmune disorders (l, 2). With steadily increasing demand for efficient and affordable therapies, speed to clinic/market is important, and biopharmaceutical companies push multiple drugs into development each year to ensure business sustainability (3-6).Downstream purification process development for therapeutic MAbs is a critical step on their path to reach clinical trials and beyond (7-9).