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.
50 kg → $3M direct manufacturing cost. A Mab A Case Study In Bioprocess Development
However, this initial process had limitations: This case study demonstrates that a modern mAb
These parameters dictated the entire bioprocess. A Mab needed high productivity (to meet 100 kg/year) but also high purity (to minimize immunogenicity). This case study begins with the cell line development. the team transformed a problematic
This case study demonstrates that a modern mAb process is not developed linearly. By integrating upstream media chemistry (clone #47B + metal modulation) with downstream flocculation and high-resilience Protein A capture, the team transformed a problematic, aggregate-prone mAb (initial yield <1.5 g/L recoverable) into a robust 6.1 g/L titer process with a 71% final recovery. The drug product met all Phase I release specifications for purity, potency, and safety.
