ThermoGenesis and Mediware Information Systems Collaborate
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ThermoGenesis Corp. and Mediware Information Systems, Inc. have announced that they will form a collaboration to develop the design for an integrated logistics system to make personalized cell and tissue therapy safer and accessible.
Currently, there is no integrated tracking system that monitors and manages the manufacturing process from cell collection to patient administration.
Personalized cell and tissue therapy products or CTT products are created from blood or tissue of a single donor and are administrated to that donor or a matched patient.
Cell therapy products, including umbilical cord blood stem cells, are used to treat patients for leukemia, lymphoma, and over 60 other life threatening genetic diseases.
ThermoGenesis' Chairman and CEO, Philip Coelho, said, "This system would comply with anticipated FDA cGTP (current Good Tissue Practice) regulations and Part 11 Electronic Records and Electronic Signature due for adoption soon."
"We expect that this system will become the industry standard for assuring safe and cost effective manufacturing of cell therapy products."
The integrated software system would take advantage of ThermoGenesis' experience in CTT products and Mediware's long track record in blood bank management and safety control systems.
The system would link three of ThermoGenesis' flagship products: BioArchive® System - used to cryopreserve and archive cord blood stem cells for future transplant, its AutoXpress™ System - used to isolate and capture stem cells and the CryoSeal® Fibrin Sealant System - used to prepare an autologous protein transfer media for affixing stem cells in a target site with Mediware's Cellular Product System (CPS™) which is designed to provide advanced configurable workflow and inventory management functionality allowing compliance with evolving cGMP and cGTP requirements.
Mediware's CEO, James Burgess, said, "This agreement places both Mediware and ThermoGenesis at the leading edge of new frontiers in the personalized medicine fields."
"It also extends Mediware's track record of leadership and innovation in developing technologies to manage the use of biologic products."
"The ability to bring more safety, transparency and liquidity to the CTT supply chain should accelerate broader use of this powerful therapeutic technology."
