Journal
ELECTROPHORESIS
Volume 37, Issue 17-18, Pages 2338-2346Publisher
WILEY
DOI: 10.1002/elps.201600078
Keywords
Cell-based assay; Charge variants; Critical quality attributes; Monoclonal antibodies; Statistical modeling
Funding
- Center of Excellence for Biopharmaceutical Technology grant from Department of Biotechnology, Government of India [BT/COE/34/SP15097/2015]
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Charge variants, namely acidic and basic variants, are typically found in mAb therapeutics. Charge heterogeneity is typically not regarded to affect safety and efficacy of the product. As a result, the commonly followed approach involves assignment of a specification for the variants based on statistical analysis of variability in levels that is seen during commercial manufacturing. This is followed by monitoring of product quality to demonstrate consistency. This paper aims to demonstrate that this perception of charge variants warrants a more in-depth investigation to evaluate the role charge variants play in safety and efficacy of a mAb therapeutic. In addition, a novel procedure has been suggested for making this assessment and alleviate the problems that are traditionally faced when isolating these variants for characterization. The suggested procedure utilizes the principles of bioseparations, cell biology, and statistics and it is demonstrated that this is significantly more efficient than the approach practiced today.
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