With revolutionary cell-based therapies, such as CAR-T (chimeric antigen receptor t-cell) for cancer, becoming a reality, developers must address a key challenge: how to manufacture high-quality, clinical-grade cell therapies at commercial scale to provide these groundbreaking treatments to as many patients as possible.
Traditional cell processing methodologies are manual and time consuming, presenting an obstacle to the large-scale manufacture of CAR-T cell therapies.
In contrast, TotipotentRX will be using Cesca’s CAR-TXpress™ platform, an automated solution that selects target cells using its patented buoyancy-activated cell separation (BACS) technology. CAR-TXpress is a multi-device platform designed to automate many of the manual steps involved in cell processing. The CAR-TXpress system can provide a comprehensive and commercially viable, automated cellular manufacturing and control (CMC) solution for the development of CAR-T and CAR-NK therapeutics.
CAR-TXpress™ eliminates the use of ficoll for isolation and replaces magnetic bead based systems used for selection procedures, thereby dramatically reducing processing time and increasing cell recoveries, in order to dramatically reduce the overall manufacturing time and cost.
The CAR-TXpress™ platform includes the following X-Series™ products:
- X-Lab™ for Cell Isolation - a semi-automated, functionally-closed, ficoll-free system for the rapid isolation of different target cells from various sources, including whole blood, bone marrow aspirates and leukopheresis products.
- X-BACS™ for Cell Selection – a semi-automated, functionally closed system that employs microbubbles to isolate target cells through buoyancy-activated cell sorting (BACS). These microbubbles bind specifically to the desired target cells increasing their buoyancy. Subsequent collection of the floating target cells coated with microbubbles provide a highly-purified preparation of target cells, with high recovery efficiency and cell viability.
- X-Wash™ for Washing and Reformulation – a semi-automated, functionally-closed system that separates, washes, and volume-reduces frozen cells or cell cultures to a programmable volume. The cells of interest never leave the cartridge and can be washed multiple times under lower centrifugation speeds eliminating the creation of cell pellets.
- BioArchive® / ClinArchive for Cryogenic Cellular Product Storage – an automated, controlled-rate, liquid nitrogen freezer intended for the cryopreservation and single-cassette based storage of clinical samples. The BioArchive provides customers who need cryogenic cellular product storage (-196°C) with a solution that combines the individualized sample storage/retrieval capacity and real-time chain of custody management.
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