February 3, 2021 -- ThermoGenesis has completed the development process for its PXP-Lavare system for automated cell processing. The company has submitted a letter to file and updated the device listing with the U.S. Food and Drug Administration (FDA).
PXP-Lavare is a good manufacturing practice (GMP) compliant system that allows for fast, automated, and reliable washing and reformation of cell suspension. Its optional cell reformation accessory is designed for use with the PXP-1000 system, an FDA-cleared medical device that is used for downstream current GMP-compliant clinical manufacturing of cell-based therapeutics.
The completed closed system includes the control module, docking station, disposable cartridge, and DataTRAK software, which captures sample processing data to assist with quality assurance and compliance with current GMP practices.
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