IsoLight® automated proteomics platform will be used for functional quality analytics for products produced on Lonza’s Cocoon® automated cell manufacturing system.

IsoPlexis, which markets single-cell functional proteomics products, is collaborating with Lonza, a CDMO, to use IsoPlexis’ IsoLight platform for cell and gene therapy manufacturing. The IsoLight will provide quality analytics for cell therapy products generated on Lonza’s Cocoon, an automated, highly flexible cell therapy manufacturing platform, according to Sean Mackay, CEO of IsoPlexis.

The Cocoon allows for centralized and decentralized manufacturing of novel cell therapies, and the IsoLight provides a solution for the functional characterization of the cell therapy product, to ensure correlative functional potency of the manufactured cell product, continues Mackay.

Officials at both companies emphasize that improved end-to-end automation on the Cocoon minimizes the need for human involvement in numerous steps, and IsoPlexis’ systems provide functional phenotyping to characterize the cell therapy product from heterogeneous cell populations better.

“This collaboration between Lonza and IsoPlexis highlights the evolution of cell therapy manufacturing,” notes Matthew Hewitt, PhD, Head of Clinical Development and Personalized Medicine at Lonza. “As we continue to scale the manufacturing of cell therapies, it will be critical to characterize the quality and performance of these products with technologies such as IsoPlexis’ IsoLight.”

“We are excited to collaborate with Lonza to shape the future of cell therapy manufacturing and quality analytics,” adds Mackay. “As cell therapies continue to grow in therapeutic importance, manufacturing processes will require more precision relating to potency and performance. Alongside Lonza’s novel platform, the IsoLight will play a key role in enabling that increased level of precision and insight into cell product performance.”

IsoPlexis’ functional phenotyping has been published with a variety of CAR-T and cell therapy biopharma companies and academic institutions in areas ranging from research to process development and clinical biomarkers.

“In understanding that cell therapy manufacturing requires more precision regarding potency and performance two things come into play. You not only need to measure cytokines because that’s how cells communicate but you also need to measure each cell because all the cells act differently,” explains Mackay. “A single cell platform can measure all the cytokines and the functions from each cell. And that’s what we do. It turns out that small subsets of immune cells produce all the cytokines. We call them superhero cells and that’s what we capture.”

Patients who have these superhero cells in their cell product end up doing well in therapy because those superhero cells are driving almost all the response in the patients by themselves, he points out.

By using the Cocoon platform’s automated programming and on-board, real-time analytics, the collaboration will seek to significantly improve the biological understanding of starting material, process, and product analytics to enable more efficient manufacturing and higher quality cell therapies.

“We know that cell therapies work,” says Mackay. “They do so in blood cancers and they’re starting to show positive data in NK cell therapies and other cancers. You’re beginning to see good preclinical evidence in liver cancers.”

Bottom line, according to Mackay, is that there are going to be a lot of different patients who could be receiving cell therapies. Question is how to do you scale up these therapies around the globe?

“For that to happen manufacturing must have a couple of things take place: it has to be scalable and modular worldwide,” continues Mackay. “You also must have an understanding of the product as it relates to patient performance. That involves an aspect of precision medicine. You need to create reproducible metrics and manufacturing processes. The Cocoon and the IsoLight are trying to address that by bringing scalable, modular self-contained performance workflows that can be used anywhere.”

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