A Mab A Case Study In Bioprocess Development Online

One critical insight: Routine HCP ELISA does not detect a specific CHO protein (Cathepsin D) that co-elutes with Mab-X during AEX. The team adds a secondary orthogonal method (LC-MS/MS) to verify HCP clearance.

The depth filters for the Protein A load are undersized by linear scale-up (based on volume). A more accurate scale-up factor——shows that the large-scale filter needs 2.5x more area than calculated. After revision, all filter capacity tests pass. A Mab A Case Study In Bioprocess Development

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"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 One critical insight: Routine HCP ELISA does not