"A-Mab: A Case Study in Bioprocess Development" is a 2009 document from the CMC Biotech Working Group illustrating the application of Quality by Design (QbD) principles to monoclonal antibody manufacturing. The 278-page study details the development, design space, and control strategies for a hypothetical product. Download the complete case study from International Society for Pharmaceutical Engineering (ISPE) A–Mab: A Case Study in Bioprocess Development - ISPE
The bioprocess development for mAb-A illustrates the importance of innovative strategies and cutting-edge technologies in bioprocess optimization. Future directions for bioprocess development include: A Mab A Case Study In Bioprocess Development
Our team selected a CHO (Chinese Hamster Ovary) cell line, the industry standard for mAbs due to its ability to perform human-like glycosylation—a critical factor for drug efficacy. "A-Mab: A Case Study in Bioprocess Development" is
This "flow-through" polishing step ensured that mAb-X achieved a purity level of >99.5%. Resin: MabSelect SuRe LX
Mock Product (Mockestuzumab): The study uses a hypothetical humanised IgG1 antibody, "A-Mab," designed for IV administration to treat Non-Hodgkin’s Lymphoma.