Current Process Analytical Technology Inadequate for Cell Therapies

According to researchers, developers of cell therapy need specially designed technologies to monitor processes that claim that the best systems speed up production and reduce costs. The conclusion is based on a study that examined the use of analytical technology (PAT) in the production of cell therapy. The key finding was that the lack of customized systems means that many developers continue to rely on platforms designed to produce drugs with large molecules.

This is a problem because cell therapy is much more complex than protein therapy, says Krishnenda Roy, Ph.D., director of the NSF (ERC) Center for Cell Technology (CMaT) at the Georgia Technology Center.

“In biologics or monoclonal antibodies, the product is a single well-defined subject. Cell therapy is a living product that changes with each manipulation, ”he says. GEN. “The cell has thousands of proteins, RNA, lipids, carbohydrates – any combination of which can be CQA [critical quality attributes], and simple changes in processes affect the properties and behavior of cells. This complexity makes it much harder.

“Existing analytical technologies are inadequate. We need PATs to be adapted for cell production. ”

Multiplexed PAT

Instead, the cell therapy industry requires technologies that are capable of tracking a variety of parameters in real time at every stage of development and production, Roy explains.

“PATs, especially multiplexed systems capable of experiencing many parameters at or in the process of the discovery and development stages, will allow us to learn every detail of how cells behave, their differentiation and growth trajectories. and how process parameters affect cells and the final product, ”he continues.

“Later, when we understand the CQA or CPP set [critical process parameters]only a few things need to be measured at the production stage to make sure the process is behaving as expected, or if controls / process changes are needed to keep the final product within CQA ”.

Supplier support

In the study, Roy and his co-authors invite developers and technology providers to work together to incorporate new sensory technology and machine learning into PAT methodology.

“Advances in PAT are needed to identify CQA and CPP, overcome constraints in ongoing operating processes, reduce total product costs, and significantly accelerate the translation of laboratory discoveries into commercialized cell therapy products,” says Roy, who adds that the industry has rewards. begins to act. “Many new PAT companies are already forming, collaborating with research consortia and therapy companies.”

One such example is the group created by Cell and Gene Therapy Catapult in June. The project, which brought together 20 pharmaceutical companies, technology providers, therapy developers and charities, is designed to evaluate the application and combination of several technologies to analyze processes in the cell and gene therapy industry.

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