Quantity and Quality Controlled Bioprocess of Chimeric Antigen Receptor (CAR)-T Cells and Integrated Continuous Bioprocessing Platform

Invention Description
Process development is very important for pharmaceutical products in production. Herein, we developed bioprocess of CAR-T cells and integrated continuous bioprocessing platform for biologics to prepare CAR-T cells or monoclonal antibody with high quality and high quantity.
1. Process development for CAR-T cells
CAR-T cell therapy is a promising therapeutic approach to cure cancer diseases. However, the quantity and quality and CAR-T cells are the critical factors in manufacturing for successful autologous treatment. Under DCB’s optimized conditions, CAR-T cells can grow to about 100 fold to the initial cell number in a 6-day expansion, and the major cell subsets of CAR-T cells are cells with function of cellular immunity, including Th1 and cytotoxic T cells. The viability of T cells was more than 95% and the T cells did not present exhaustion phenotype. In addition, CAR-T cells prepared in DCB’s condition presented an increase of in vitro antigen specific cytotoxicity and IFN-γ production, as compared to benchmark control. Altogether, CAR-T cells prepared in DCB’s condition showed high expansion and good quality .
2. Integrated continuous bioprocessing platform
Integrated continuous bioprocessing technology has high productivity and cost saving benefit, which combines the upstream (Cell culture) and downstream (Purification) processing. In the high density perfusion culture system, the VCD achieved 50~80x106 cells/ml and producing antibody about 2.0 g/L/day in 6 weeks.

a. Integrated continuous biomanufacturing
b. High cell density perfusion culture
c. Continuous chromatography for downstream processing

Competitive Advantages
1. Process development for CAR-T cells

a. Large amount of T cells or CAR-T cells are required for the development and therapy. In our system, T cells can be highly expanded within 1 to 2 weeks, and the activity of T cells can be maintained, leading to reduction of the loading of donors and the cost of preparation. It would be a stable platform to prepare T cells for researchers, companies, or medical institutes.
b. Monitoring the cell characteristics and T cell populations could efficiently control the T cell property in the process. In our system, T cells majorly are early differentiated T cells with cytotoxic activity, including naïve/stem cell memory and central memory Th1 and cytotoxic T cells. It could increase the therapeutic potency of CAR-T cells and reduce the dose for treatment.

2. Integrated continuous bioprocessing platform

a. The continuous bioprocessing based biopharmaceutical manufacturing is more profitable than traditional batch/fed-batch processing in increasing quality and quantity.
b. Continuous bioprocessing technology has higher productivity and cost saving benefit than traditional fed-batch processing.

Business Opportunity
Licensing, Co-development

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