Integrated Workflow Solutions for Development of Cellular Therapies
Thermo Fisher Scientific
Advancements in cellular therapies has mandated the rapid development of closed automated systems, integrated workflows and analytical solutions to increase consistency while decreasing costs. Challenges in manufacturing cell therapy products include laborious and contamination prone cell isolation techniques, scale-up of cell engineering technologies, and standardization of assays to ensure identity, purity, and potency. To address these key challenges, we have developed tools that allow for efficient and reliable isolation, engineering, and characterization of cell products.
The Rotea Counterflow Centrifuge System provides cell processing of numerous therapeutic cell types with a high level of reproducibility at every level of R&D and clinical manufacturing. The Rotea is able to separate, isolate, wash & concentrate cells while maintaining a closed system that ensures sterility of the product. Further, users can design protocols to fit their intended cell type and application allowing for a modular system that delivers high levels of cell recovery and viability. Using an integrated workflow with qualified media and reagents, isolated cells can be engineering using the LV-MAX Lentiviral production system, which facilitates production of high titer virus in a scalable manner. Finally, identity and purity of the resulting cell therapy product can be measured using the traditional flow-based Essential Human Phenotyping kits and a novel qPCR-based PureQuant Methylation assay. Importantly, the PureQuant assays remove variability and input requirements associated with flow cytometry, allowing for decreased cell input and standardized data interpretation. These assays, together with downstream functional assays, provide comprehensive methods to qualify cell therapy products. Together, these tools enable a streamlined workflow to develop cell products from R&D through clinical manufacturing.