The market for monoclonal antibodies (mAbs) is rapidly expanding, expected to more than double by 2030 and currently worth over $330 billion. One of the key challenges in mAb development is measuring and maintaining critical quality attributes (CQAs), with aggregation being a major concern. Aggregates can impact product quality and patient safety, making their detection crucial.
Traditionally, aggregation screening is done later in the development process, risking the elimination of stable clones. However, new technologies are enabling the early detection of aggregation, allowing developers to select the most stable clones more efficiently. Plate-based assays, for example, can detect aggregation in 96 samples simultaneously in just 15 minutes, significantly faster than traditional methods like HPLC-SEC and DLS.
A comparison study between a plate-based aggregation assay and HPLC-SEC showed comparable results, indicating the reliability of the new technology. By detecting aggregation earlier in the development process, developers can save time and costs by dropping unstable clones before investing further resources. Automation of plate-based assays in the future may further enhance their utility.
Managing aggregation earlier in development can ultimately benefit patients by potentially shortening the long timelines of mAb development, bringing life-saving therapies to market sooner.
About the author, Dr. Elisa Nent, leverages her expertise in cellular biology to support customer needs in cell line development as the global product manager for Cell Health at Beckman Coulter Life Sciences. The potential of early aggregation detection to streamline mAb development processes highlights the importance of continued innovation in the field.
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