Bio-Matrix Scientific Group Inc. has announced it has entered into a contract with Validation Systems, Inc. to complete and finalize its FDA Good Manufacturing Practices (cGMP) Quality Systems documentation.
Once this documentation is finalized and the Company receives clearance from the State of California, stem cell specimens can be cryogenically stored.
Bio-Matrix intends to open in the months ahead what it believes to be the first commercial adult stem cell processing and banking facility in the world for harvesting stem cells from adipose or fat tissue, which is a new dimension in stem cell banking.
VSI will provide Bio-Matrix with validation and technical services for its cGTP (Good Tissue Practices) and cGMP (Good Manufacturing Practices) for the processing and cryo-storage (in liquid nitrogen) of adult stem cells.
"We believe our relationship with VSI represents the last piece in completing our goal of getting the facility open,” said Dr. David Koos, Chairman and CEO of Bio-Matrix. “Once VSI and Bio-Matrix finalize the quality systems documentation and we gain the anticipated regulatory approvals, we can then implement our business model – moving towards revenue."
Dr. Koos explained VSI will handle Bio-Matrix’s validation master plan by outlining the tasks required to complete the validation process. VSI will also establish the level of validation for each system/piece of equipment.
“To achieve a smooth validation process, the concepts of validation must be incorporated during the design phase. VSI’s experience in the biotech, pharmaceutical and medical device industries allows its professionals to provide broad reviews encompassing not only validation concerns, but also long-term control, current technology, cost/benefits, ease of maintenance and ability to meet regulatory requirements,” said Dr. Koos.
Bio-Matrix’s new 15,000 sq. ft. state-of-the-art facility, which is located in the heart of San Diego’s biotechnology corridor, will house the Company’s secure Cryogenic Stem Cell Bank, three research laboratories, aseptic cellular/tissue class 10,000/100 processing laboratory, hematology, microbiology and flow cytometry laboratories.