Having evaluated the platform, the Beckman Research Institute of City of Hope now plans to integrate the technology into its workflow to manufacture investigational CAR-T cell immunotherapy.
It is the first of the company’s technology access program collaborators to formally integrate the Curate Cell Processing System in this manner. Industry and academic players have been testing the system, under non-disclosure.
“This particular investigator – City of Hope - is working on T cell therapies to address infectious disease, specifically HIV. Unbiased, high-efficiency cell recovery ensures that there is maximal recovery of the specific T cells required for our collaborators' therapeutic approach.
"And since the initial steps for autologous therapies are similar, regardless of therapeutic application, the Curate system is an appropriate solution for both cancer and non-oncology cell therapy applications, from HIV to autoimmune disorders,” Joan Haab, senior vice president, manufacturing and supply chain operations, told BioPharma-Reporter.
The use of Curate’s system in the therapeutic manufacturing workflow maximizes recovery of a patient’s white blood cells to be used in producing the cell therapy, she continued. “Through gentle processing with the closed Curate system, the City of Hope team can protect cellular health, ensuring isolated cells have maximal viability while reducing the risk of contamination or sample loss. And because it's automated, processing time is short and will not require highly skilled labor to execute."
The company outlined in February how it had spent six years working on the platform, describing then how it had cracked one of the biggest problems in cell therapy: extracting enough potent cells to treat chronically sick patients.
Cost reduction
The platform has the potential to enable up to a 50% reduction in the total cost of autologous cell therapy production and a like reduction in the days required to produce a CAR-T dose, according to the developer.
Curate's chief technology officer, Tony Ward, told us previously that the system has "industry-leading" ability to produce more high-quality white blood cells for CAR-T oncology cures.
“Today, autologous cell therapy manufacturing typically starts with five steps, taking longer than four hours to obtain a white blood cell preparation for T-cell selection and activation.
“Across these steps, one can lose up to 90% of the cells of interest. The Curate system is highly superior, isolating white cells with high recoveries, without bias or damage, in an easy-to-use closed microfluidic system with just a single step taking about 45 minutes. There is minimal operator hands-on time. On average, our system recovers more than 4-fold more T central memory cells than density-based methods. Our single platform also provides greater than 3-log wash efficiency in a single pass and can concentrate the product to industry needs without breaking the closed loop sterility."
He said the platform is looking to address a fundamental challenge for the industry: inconsistent and low recovery starting cell material.
“The Curate System’s gentle processing delivers a higher yield of more naïve, minimally manipulated T cells, which should enable better engraftment and persistence profiles for making improved therapies. Recovering more naïve and central memory T cells of the highest quality is key to optimizing the end-to-end production workflow. It reduces days, process steps, and the associated costs of cell culture expansion, along with dramatically reducing capital infrastructure spending and skilled labor requirements.”
Plans are underway for commercialization of the platform later this year.