The market for monoclonal antibodies (mAbs) is booming, with a projected value of over $330 billion set to more than double by 2030. However, developers face challenges in measuring and maintaining critical quality attributes (CQAs), including the growing concern of protein aggregation. Aggregates can impact product quality and patient safety, making it crucial for developers to monitor aggregation levels to meet regulatory expectations.
Traditionally, aggregation screening occurs late in the development process, leading to potential risks in selecting the most stable clones. Emerging technology, such as plate-based assays, now enables developers to detect aggregation earlier in the development process, allowing for faster selection of stable clones and reducing development timelines.
A new high-throughput, plate-based screening tool has been introduced, allowing developers to measure aggregation in 96 samples simultaneously with increased efficiency compared to existing methods like HPLC-SEC and DLS. The technology has shown comparable results to traditional methods, demonstrating high reproducibility and effectiveness in detecting aggregates.
By managing aggregation earlier in the development process, developers can potentially save time and costs, ultimately benefiting patients by shortening mAb development timelines. Improvements in managing CQAs have the potential to bring lifesaving therapies to patients sooner.
Dr. Elisa Nent, with expertise in cellular biology, supports customer needs in cell line development as the global product manager for Cell Health at Beckman Coulter Life Sciences. With advancements in technology and automation, plate-based assays for detecting aggregation offer a promising solution to streamline mAb development processes and accelerate the delivery of new therapeutic options to patients in need.
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