: Purification steps (chromatography and filtration) are optimized to remove impurities like variants and viruses.
In bioprocess development, traditional "Quality by Testing" approaches rely on restrictive recipe-like steps and intensive end-product checks. In contrast, the A-Mab approach builds quality directly into the manufacturing process using a highly structured, sequence of development milestones: A Mab A Case Study In Bioprocess Development
Centrifugation followed by depth filtration was implemented to remove cells and debris. The clarification process was optimized to maintain low turbidity, reducing the load on subsequent chromatography steps. 3.2. Capture Step: Protein A Affinity Chromatography The clarification process was optimized to maintain low
Mab-X binds to a strong cation exchanger (Poros 50 HS) at pH 5.5. The team runs a shallow salt gradient (0 to 150 mM NaCl over 30 column volumes). This resolves the main peak from the deamidated variant, which elutes slightly earlier. Collection windows are narrowed to 70-85% of peak height, discarding tails. The team runs a shallow salt gradient (0