Automated cell processing company Cesca Therapeutics Inc (NASDAQ:KOOL) said on Tuesday that it has filed a Device Master File (MAF) with the US Food and Drug Administration (FDA) for its X-LAB automated cell processing device to support clinical development in the cell-based therapeutics market.

The Device Master File (MAF) has been initiated by the company's device subsidiary, ThermoGenesis Corp.

According to the company, the X-LAB device isolates and purifies target cell fractions from blood, bone marrow or leukapheresis in a "closed system," with precision and high efficiency. It serves as an efficient and ficoll-free platform to isolate human T cells for chimeric antigen receptor-T (CAR-T) cell therapeutics.

This MAF contains all the relevant information that the US FDA will need to allow principal investigators to include the company's systems in their investigational new drug applications, or INDs, while also protecting its intellectual property.

In 2019, the company intends to add Thermogenesis' X-WASH and X-BACS automated cell processing systems, which share essentially all the proprietary construction features as the X-LAB, to this MAF.

Concurrently, the X-WASH is a semi-automated, functionally-closed system that washes and reformulates cells of interest by removing (washing) contaminants in a precise and rapid process, while yielding cell recovery, viability and purity of more than 90% of the starting cell population. The X-BACS purifies and/or activates cells of interest from blood, bone marrow or leukapheresis in a semi-automated "closed system" process with precision and speed, concluded the company.