A Mab A Case Study In Bioprocess Development -

Humanized IgG1 mAb targeting a cancer antigen. Indication: Solid tumors. Target Dose: 500 mg per patient, every 3 weeks. Annual Demand: 50 kg (clinical → early commercial). Critical Quality Attributes (CQAs):

You have the pure protein. Now, how do you store it? Proteins are fragile; they can denature (unfold) with changes in temperature or pH. A Mab A Case Study In Bioprocess Development

At high concentrations, mAb-X became too viscous (thick and syrupy). This would make it difficult to inject through a thin needle. Humanized IgG1 mAb targeting a cancer antigen