The market for monoclonal antibodies (mAbs) is rapidly expanding, with a worth of over $330 billion and expected to double by 2030. A critical quality attribute (CQA) that developers are focusing on is aggregation, where proteins stick together and can impact product quality and patient safety. Traditionally, aggregation screening occurs late in the process, leading to potential risks and delays in development timelines.
However, new plate-based assays are enabling developers to detect aggregation earlier in the development process, allowing them to select stable clones efficiently. These assays can generate data for 96 samples in just 15 minutes, compared to traditional methods that take much longer. Furthermore, the results from these plate-based assays are comparable to existing technologies, demonstrating high reproducibility and effectiveness in ranking samples based on aggregation levels.
By managing aggregation early on, developers can potentially save time and costs by dropping unstable clones before investing further resources. This advancement in technology not only benefits developers but ultimately benefits patients by potentially shortening the long development timelines of mAb therapies.
Dr. Elisa Nent, global product manager for Cell Health at Beckman Coulter Life Sciences, highlights the importance of managing CQAs in mAb development and the potential benefits of using automation to further improve plate-based assays. With advancements in technology, developers can streamline the screening process and bring life-saving therapies to patients sooner.
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