The market for monoclonal antibodies (mAbs) is rapidly growing, with the market worth over $330 billion and expected to double by 2030. One key challenge for developers is measuring and maintaining critical quality attributes (CQAs), with aggregation being a significant concern. Aggregates can impact product quality and patient safety, making it crucial to monitor and control aggregation levels.
Traditional methods of screening for aggregation in mAbs are time-consuming and costly, often leading to delays in development timelines. However, emerging technologies, such as plate-based assays, are now enabling developers to detect aggregation earlier in the process. These tools offer high-throughput screening capabilities, allowing for efficient measurement of aggregation levels in multiple samples simultaneously.
In a recent study comparing a plate-based aggregation assay to traditional methods like HPLC-SEC, the new technology performed comparably and showed high reproducibility. By starting aggregation screening earlier in development, developers can save time and costs by identifying stable clones before investing significant resources in their further development.
Managing aggregation earlier in the development process has the potential to shorten mAb development timelines, bringing lifesaving therapies to patients sooner. With the continued advancement of automation in plate-based assays, developers can further streamline the process and improve efficiency in selecting the most stable molecules for development.
Overall, the development of new technologies for detecting aggregation in mAbs offers promising opportunities to improve the efficiency and effectiveness of mAb development, ultimately benefiting both developers and patients in need of new therapeutic options.
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