The molecule in this case study is , an IgG1 therapeutic antibody aimed at oncology indications. Target Product Profile (TPP) Indication: Solid tumor oncology. Mechanism of Action: Targeted receptor antagonism.
While perfusion culture offers high density, a was selected for mAb-101 due to its operational simplicity, lower risk of mechanical failure, and easier tech transfer to existing manufacturing facilities. Seed Expansion (N-1) Production Bioreactor (N) Temperature 36.5°C (Shift to 33.0°C on Day 5) pH Control 7.00 ± 0.05 6.90 ± 0.10 Dissolved Oxygen (DO) Feeding Strategy None (Batch) Bolus feed (Days 3, 5, 7, 9, 11) A Mab A Case Study In Bioprocess Development
Develop a robust process capable of seamless technology transfer to a 2,000L pilot facility. The molecule in this case study is ,
A-mAb: A Case Study in Bioprocess Development and the Evolution of QbD While perfusion culture offers high density, a was
Low pH elution (pH 3.5 using sodium acetate) was optimized to maximize recovery while minimizing aggregate formation during the acid stress. Viral Inactivation (Low pH)
The harvest fluid contained significant cellular debris, host cell proteins, and DNA that required rigorous removal through a platform three-step purification process. Harvest and Clarification
