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February 3, 2021, 08:30, US Eastern Time
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/PRNewswire/-ThermoGenesis Holdings, Inc. (Nasdaq:
) Is the market leader in automated cell processing tools and services in the field of cell and gene therapy. It announced today that it has completed the development process, has filed documents and updated the equipment list to the U.S. Food and Drug Administration (FDA). For PXP
-Lavender system. PXP-LAVARE is a GMP-compliant automatic cell processing system that can quickly, automatically and reliably wash and reform cell suspensions. The PXP-LAVARE system is an optional cell reforming accessory designed for use with the PXP™-1000 system. The PXP™-1000 system is a 510(k) Class II medical device approved by the US FDA for downstream cGMP compatible Clinical production of cell-based therapies, such as chimeric antigen receptor-T (CAR-T) cells.
"We will continue to develop and improve our wide range of automated cell processing tools in response to the rapid growth of the cell and gene therapy market."
PhD, CEO of ThermoGenesis. "The latest documents prove our team's commitment and leadership in this field."
PXP-LAVARE system is a complete, automated closed system, including PXP-LAVARE control module, docking station, disposable cassette and DataTRAK software, which can capture sample processing data to help quality assurance and compliance with current Good Manufacturing Practices (cGMP) ).
ThermoGenesis Holdings, Inc. develops, commercializes, and sells a series of automated technologies for CAR-T and other cell-based therapies. Currently, the company sells a complete set of solutions for automated clinical biological storage, point-of-care applications and immuno-oncology automation, including its semi-automated, functionally closed CAR-TXpress™ platform, which simplifies the manufacturing process. Emerging CAR-T immunotherapy market. For more information about ThermoGenesis, please visit:
Paula Schwartz of Rx Communications
Source: ThermoGenesis Holdings, Inc.
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