To ensure patient safety, mAb A underwent low pH viral inactivation. This was followed by "polishing" steps using Ion Exchange Chromatography (IEX) to remove remaining aggregates and leached Protein A. The final step, nanofiltration, provided a size-based clearance of potential viral contaminants. Phase 3: Analytical Characterization – Ensuring Quality
Screening for clones with high productivity, stable expression, and favorable growth characteristics. Upstream Processing (Cultivation) A Mab A Case Study In Bioprocess Development A Mab A Case Study In Bioprocess Development
The "A Mab" case study offers six universal takeaways for bioprocess engineers: To ensure patient safety, mAb A underwent low
Given the target product profile (chronic therapy requiring high doses), the team chose a high-titer fed-batch process . Using a proprietary chemically defined medium and a bolus feeding strategy (glucose and amino acids), they increased viable cell density to ~20 × 10⁶ cells/mL. By month six, titers reached 5 g/L—a tenfold improvement. By month six, titers reached 5 g/L—a tenfold improvement