Recently, ThermoGenesis’s automated, functionally-closed CAR-TXpress™ platform has received attention form international academic journal ‘Biotechnology Advances’.
In the paper, titled ‘Standardizing CAR-T therapy: Getting it scaled up’, the authors concluded that achieving mass production of CAR-T therapy without sacrificing its personalized nature is a worldwild challenge for making CAR-T a key element in the next generation of precision medicine, which can be achieved by standardizing 7 prominent factors that collectively determine the scale of CAR-T manufacturing.
They identified 7 factors, i.e., manufacturing process, source materials, viral vectors, ancillary reagents, quality control, post-treatment immune monitoring, and government regulation whose standardization is deterministic to the success of large scale CAR-T production.
The manufacturing process should result in safe yet clinically effective cell products, and be scalable so that more patients could benefit from such technologies without sacrificing the quality and reproducibility of the products. To achieve this goal, the authors suggested using closed automated system and quality-by-design (QbD).
Automation is of particular use in standardizing the manufacturing process, from cell preparation, selection, activation, expansion, transduction, to formulation. In this section, the authors highlighted the CAR-TXpress™ platform, which developed by ThermoGenesis, a subsidiary of Cesca Therapeutics which is invested by Boyalife Group.
CAR-TXpress™ is a multi-device platform designed to automate many of the manual steps involved in cell processing. The 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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