A Mab A Case Study In Bioprocess Development [verified]

No centrifugation used because A Mab’s small aggregates (5%) were shear-sensitive.

Changed from top addition of Na₂CO₃ to a dip-pipe with an efficient mixing zone and implemented pH-stat control with CO₂ sparging . At 2,000L stainless steel bioreactor, aggregation dropped to 1.5%.

A Mab’s high concentration (20 g/L intermediate) posed a challenge. Standard 20 nm filters fouled rapidly. The solution: with pre-filtration using 0.1 µm and operation at constant pressure (2 bar). Flux dropped only 30% over 4 hours, acceptable for GMP. A Mab A Case Study In Bioprocess Development

The primary goal of this development program was to transition mAb-X from a discovery-phase lead candidate into a commercially viable manufacturing process. Process Goals Achieve an upstream harvest titer of > 5.0 g/L. Purity: Ensure monomer content with host cell protein (HCP)

The traditional "batch" mindset—where processes are a series of discrete, start-stop steps—is giving way to a more integrated, continuous paradigm. This shift is perhaps the most significant trend in bioprocessing, promising smaller facility footprints, lower capital costs, and increased agility. The development story of A-mAb concludes with a look at this horizon, as exemplified by the . No centrifugation used because A Mab’s small aggregates

The team chose (Chinese hamster ovary) cells, the industry workhorse. For A Mab, they used a glutamine synthetase (GS) knockout system to eliminate ammonia build-up and enable selection with methionine sulfoximine (MSX).

Humanized IgG1 (pI 8.2), expressed in CHO-K1 cells. The Challenge: High aggregate formation (>15%) and low viral clearance capability during Protein A capture. A Mab’s high concentration (20 g/L intermediate) posed

Media formulation significantly impacts both titer and glycosylation.