For mAb-X, high-concentration formulation was required for subcutaneous injection (a shot under the skin) rather than an intravenous (IV) drip. This meant packing a lot of protein into a small volume (100 mg/mL).
Automated pH control using 1M sodium bicarbonate (not NaOH, which would cause localized pH spikes). Additionally, the team adds 50 mM arginine to the harvest hold tank, which acts as a chaotropic agent to stabilize the antibody. A Mab A Case Study In Bioprocess Development
Low pH hold (pH 3.6 for 60 minutes) was used. But with A Mab’s sensitivity, they optimized to pH 3.7 for exactly 30 minutes – no longer, no shorter. Validation showed >4 log reduction of model virus (xMuLV). Additionally, the team adds 50 mM arginine to
A Mab reached the clinic in 28 months from transfection – 6 months ahead of schedule. Today, it’s a blockbuster therapy. But the bioprocess continues to evolve. The team is now implementing (perfused N-1 and connected capture) to boost productivity to 15 g/L and reduce COGS by 40%. Validation showed >4 log reduction of model virus (xMuLV)