Bio-Matrix Scientific Group, Inc. has announced that the construction and installation of its new Stem Cell Class 10,000 Processing Laboratory has been completed.
Brian Pockett, Managing Director and COO, stated, “The new class 10,000 laboratory is custom-built to the highest industry specifications. The new laboratory is designed to meet current FDA cGMP (Good Manufacturing Practices) requirements, as well as anticipated more extensive requirements in future. We believe that we can begin the storage of specimens during the first quarter of 2007 after the installation and testing of all related necessary equipment.”
A Company spokesperson noted that management believes this will be the first commercial adult stem cell processing and banking facility in the United States focused on stem cells derived from fat tissue. The Company is currently not aware of any other entities commercially processing and banking adipose-derived stem cells at this time.
The installation and validation of Bio-Matrix' class 10,000 laboratory marks a major milestone in the Company's goal to offer state-of-the-art and cost-effective stem cell processing and cryopreservation.
Availability of these cleanrooms, and their validation to good manufacturing practices (cGMPs), now allows Bio-Matrix to further focus energy on the installation of 'closed' system cellular processing equipment that we expect will not only comply with current FDA cGMP/cGTP requirements, but exceed that currently offered in the industry.
Bio-Matrix’ new 15,000 sq. ft. state-of-the-art facility, located in the heart of the San Diego biotechnology corridor, will house Bio-Matrix’s secure Cryogenic Stem Cell Bank, three Research laboratories, aseptic cellular/tissue class 10,000/100 processing laboratory, hematology, microbiology and flow cytometry laboratories.