Loading...
  •  

Cesca Therapeutics Submits Device Master File (MAF) with the FDA for the X-LAB® Automated Cell Processing Devices

Cesca Therapeutics Submits Device Master File (MAF) with the FDA for the X-LAB® Automated Cell Processing Devices

November 13, 2018

RANCHO CORDOVA, Calif., Nov. 13, 2018 /PRNewswire/ -- Cesca Therapeutics Inc. (NASDAQ: KOOL), a market leader in automated cell processing and point-of-care, autologous cell-based therapies, today announced that its device subsidiary, ThermoGenesis® Corp., has filed a Device Master File (MAF) with the U.S. Food and Drug Administration (FDA) for its X-LAB® automated cell processing device.

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 also 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 FDA will need to allow principal investigators to include Cesca's systems in their investigational new drug applications, or INDs, while also protecting Cesca's intellectual property.

Philip Coelho, ThermoGenesis's Chief Technology Officer, explained, "An MAF is the device equivalent of a Drug Master File, or DMF. As such, the filing represents a key milestone for Cesca, as it will help support the use of X-LAB in the clinical development of CAR-T therapeutics as well as for premarket submissions in which reagents and devices are used in the manufacturing and processing of the final drug. X-LAB's MAF filing advances ThermoGenesis' commitment to support clinical development of the ever-growing cell-based therapeutics market, including the most recent advances in the immuno-oncology field."

Next steps
Management noted that it 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 in 2019. 

  • The X-WASH is a semi-automated, functionally-closed system that washes and reformulates cells of interest by removing (washing) contaminants, such as cryoprotectants or spent growth media, 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.

X-BACS utilizes gas-filled microbubbles linked to antibodies to bind to specific antigens on target cells, causing them to separate from non-target cells by "buoyance," allowing them to be harvested during a simple centrifugation process. This results in cell recovery, viability and purity of great than 90%.

The X-LAB, X-WASH and X-BACS automated cell processing devices constitute Cesca's CAR-TXpress™ platform, a proprietary, high efficiency, low cost, semi-automated manufacturing solution introduced in 2018 to address the time consuming and cost related challenges faced by today's CAR-T developers.

About Cesca Therapeutics Inc.        
Cesca Therapeutics Inc. develops, commercializes and markets a range of automated technologies for CAR-T and other cell-based therapies. For more information, please visit: www.cescatherapeutics.com.

Company Contact:
Cesca Therapeutics Inc.
Wendy Samford
916-858-5191
ir@cescatherapeutics.com

Investor Contact:
Rx Communications
Paula Schwartz
917-322-2216
pschwartz@rxir.com

Cision View original content:http://www.prnewswire.com/news-releases/cesca-therapeutics-submits-device-master-file-maf-with-the-fda-for-the-x-lab-automated-cell-processing-devices-300748974.html

SOURCE Cesca Therapeutics