At a recent clinical oncology conference, FDA Commissioner Scott Gottleib declared that “we are at a turning point in the history of cancer […] where individual health and wellness are more clearly and more rapidly becoming a beneficiary of technologic progress.” In part, the FDA Commissioner is referring to the fast-moving area of cell and gene therapies. With recent FDA-approved cell-based CAR-T therapies, pharma companies are providing medicines that reprogram a patients’ own cells to attack and destroy hematological cancers, specifically, certain types of relapsed leukemias and lymphomas, that were once considered intractable. Ongoing trials for multiple myeloma are also producing promising results.
While the clinical efficacy remains promising, challenges still remain in manufacturing these groundbreaking therapeutic treatments as each dose is effectively a bespoke product for each individual patient. Current CAR-T commercial manufacturing processes are typically labor intensive, expensive, and still rooted in hands-on research-scale methods. Thus, automated manufacturing systems are now needed to enable our pharma customers to dramatically scale-up delivery of these therapies in a safe and cost-efficient manner.
At GE Research, a cross-disciplinary mission-based team is focused on addressing the needs in this emerging market with the design and development of a modular platform for commercial scale manufacturing. The platform technologies that we have developed enable the automated and closed processing of patient input material through multiple steps: isolate the critical immune cells, engineer those cells to identify and kill the cancer, expand the modified cells to create an effective dose, and finally to concentrate and formulate the cells for infusion back into a patient, spanning a 12-day process. In addition to automating the process, closing the process, i.e., ensuring the patient’s cells are manipulated in a sterile manner, is an integral aspect to the platform technologies to minimize the associated risks of operator error and batch contamination.
The platform is based on single-use disposable kits with flexible fluidic architectures capable of executing various emerging customer workflows on only a few pieces of automation hardware. The device that supports the most time-consuming and complicated steps in the manufacturing process have also been designed with compactness and usability in mind to enable cost effective scale out of these cell therapy factories.
With our goal of industrializing immunotherapy and setting the industry standard in cell therapy tools, the GE Research Immunotherapy Platform Project team has developed a platform approach from concept to advanced prototype in two and half years and is in the process of transitioning the technology to the GE Healthcare product teams, working with them to accelerate an aggressive productization timeline.
Capabilities utilized for Industrializing Immunotherapy project
Working from the molecular scale through human health and disease by building novel technology solutions for cell analysis and imaging applicationsRead more