The market for monoclonal antibodies (mAbs) is projected to double by 2030, with a current value of over $330 billion. Among the challenges faced by developers in this field is the measurement and maintenance of critical quality attributes (CQAs), including aggregation. Aggregates can impact product quality and patient safety by masking key residues and triggering immune reactions.
Traditionally, aggregation screening occurs late in the development process, which can be time-consuming and costly if the lead clones turn out to be suboptimal. However, advances in technology now allow for earlier detection of aggregation using plate-based assays. These assays, such as a high-throughput screening tool, enable the measurement of aggregation in 96 samples simultaneously, significantly speeding up the process compared to traditional methods like HPLC-SEC and DLS.
In a study comparing the new aggregation assay to HPLC-SEC, both technologies performed comparably, with low variation and high reproducibility. The results ranked samples effectively by aggregation level, allowing for the selection of stable molecules. Starting aggregation screening earlier in the development process can save time and costs by identifying problematic clones sooner.
Managing aggregation earlier in the development process has the potential to shorten mAb development timelines, ultimately benefiting patients by bringing therapies to market sooner. Automation of plate-based assays in the future could further enhance their utility and efficiency. Dr. Elisa Nent, a global product manager for Cell Health at Beckman Coulter Life Sciences, emphasizes the importance of managing CQAs to improve the efficiency and effectiveness of mAb development.
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