Monitored via Size Exclusion Chromatography (SEC-HPLC) and Capillary Electrophoresis (CE-SDS). Final aggregate levels were kept below 0.5%.
Traditional mAb purification involves a step platform: capture with Protein A, followed by two polishing steps for impurity removal. However, several case studies highlight how this can be optimized or replaced for greater efficiency and lower cost. A Mab A Case Study In Bioprocess Development
Physical, chemical, or biological properties (such as glycosylation patterns or charge variants ) that must stay within a specific range to ensure safety and efficacy. However, several case studies highlight how this can
This bioprocess development case study highlights the importance of an integrated approach to upstream and downstream engineering. By optimizing the expression system, implementing a single-use clarification train, and leveraging orthogonal chromatography steps, the process achieved: A final bioreactor titer of An overall downstream recovery yield of 74% High-purity drug substance meeting all CQAs By optimizing the expression system
Strategy: The scale-up was modeled keeping the volumetric mass transfer coefficient ( kLak sub cap L a ) constant between scales (
Poros 50HS, pH 5.0, salt gradient.