A: Mab A Case Study In Bioprocess Development !full!

From Flask to Drum: A Case Study in Monoclonal Antibody (mAb) Bioprocess Development

For process engineers, A Mab is a textbook example: rigorous science, meticulous data, and adaptive problem-solving. Whether you are developing your first mAb or your tenth, this case study reminds us that the process is the product.

A Mab is a humanized monoclonal antibody targeting a specific antigen involved in the progression of a certain type of cancer. The antibody was developed to provide a more effective and targeted treatment option for patients with this disease. The development of A Mab involved a comprehensive bioprocess development program aimed at optimizing the production of high-quality material. A Mab A Case Study In Bioprocess Development

Phase 1: Cell Line Development – The Manufacturing Engine

Final Fed-Batch Process:

3.3 Polishing: Cation Exchange (CEX) and Anion Exchange (AEX)

• Reversible self-association (viscosity > 30 cP at 25°C)
• Opalescence (turbidity > 30 NTU)
• Subvisible particles (>10,000 per container)