A Mab A Case Study In Bioprocess Development

[Quality Target Product Profile (QTPP)] │ ▼ [Critical Quality Attributes (CQAs)] │ ▼ [Risk Assessment / FMEA] │ ▼ [Critical Process Parameters (CPPs)] │ ▼ [Design Space] │ ▼ [Control Strategy] From Target Profile to Control Strategy

, specifically aggregates and fragments, which threatened the stability and efficacy of the final therapeutic. The Solution: A Quality by Design (QbD) Approach Instead of traditional trial-and-error, the team utilized a QbD framework to identify Critical Quality Attributes (CQAs): Upstream Optimization: By fine-tuning the feed strategy A Mab A Case Study In Bioprocess Development

Agitation rates at the 2,000 L scale were restricted to a maximum tip speed of 1.5 m/s to prevent shear damage. [Quality Target Product Profile (QTPP)] │ ▼ [Critical

The case study concludes with a summary of key performance indicators (KPIs) for Mab-X: which promises to reduce resin costs

Future optimization work will explore the transition toward an end-to-end continuous manufacturing platform. This includes testing continuous multi-column chromatography (MCC) for the Protein A capture step, which promises to reduce resin costs, minimize footprint, and further increase production throughput.