The market for monoclonal antibodies (mAbs) is booming and is expected to double by 2030, reaching over $330 billion. One crucial quality attribute that developers are focusing on is aggregation, where proteins stick together, potentially affecting the mAb’s function and patient safety. Traditionally, aggregation screening occurs late in the development process, leading to costly and time-consuming setbacks if unstable clones are selected. However, with new plate-based assays, developers can now detect aggregation earlier, speeding up the selection process and potentially cutting down development timelines.
By utilizing high-throughput, plate-based screening tools, developers can measure aggregation in 96 samples simultaneously in as little as 15 minutes. These tools are more efficient compared to traditional methods like HPLC-SEC and DLS, allowing for quicker and more cost-effective assessments of mAb stability. Studies have shown that plate-based assays provide comparable results to existing methods, demonstrating their reliability and reproducibility.
Managing aggregation earlier in the development process not only benefits developers by saving time and costs but also has the potential to bring lifesaving therapies to patients sooner. With shorter development timelines, patients can have access to new therapeutic options faster, ultimately improving their healthcare outcomes. With automation on the horizon for plate-based assays, the future of mAb development looks promising, offering more efficient and accurate ways to monitor critical quality attributes.
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