Process characterization involves understanding how various parameters affect these quality attributes. This is often done using a approach to efficiently study multiple variables at once.
| Component | Cost per gram mAb | |-----------|------------------| | Media & feeds | $18 | | Protein A resin (reused 50 cycles) | $12 | | Polishing resins & buffers | $8 | | Filtration (depth, virus, UF) | $7 | | Labor & QC | $15 | | | $60 / g | A Mab A Case Study In Bioprocess Development
Identifying product attributes (e.g., glycosylation, aggregation, deamidation) that impact clinical performance. At the 10,000 L scale, the impeller tip
At the 10,000 L scale, the impeller tip speed is higher than in pilot reactors. Initial runs show 15% lower viability at harvest. The solution is to reduce the agitation rate from 180 rpm to 120 rpm and switch to a marine impeller (rather than Rushton turbines), which provides adequate mixing with lower shear. Dissolved oxygen is maintained via larger sparger rings. Dissolved oxygen is maintained via larger sparger rings