NEW YORK, July 24, 2012 /PRNewswire/ -- IntelliCell BioSciences, Inc. ("Company") (OTCQB: SVFC) announced today that it has received the results of its independent laboratory audit by Biologic Consultant Group and the audit showed that the new lab at 460 Park Avenue, New York, NY was cGTP compliant.
According to Holly Scott, Senior Consultant, Audits & Regulatory Support for Biologics, Human Tissue, Drug & Dietary Supplement Industries & Clinical Trial Investigations of the Biologic Consultants Group, "Since the initial FDA inspection, Intellicell BioSciences has done everything necessary to demonstrate compliance with the HCT/P regulations 21 CFR 1271, and in my opinion you have now established a higher standard of controls for your autologous SVF product than is usually observed."
According to Intellicell's Chairman/CEO Steven Victor MD, "This is great news and we have worked hard over the past 18 months to design, build and have our new facility FDA cGTP compliant. The FDA Warning Letter March 13, 2011 was on an inspection of the old beta site facility which was in the process of being closed as we moved to our new facility on April 23, 2012. We are proud of all our staff and their hard work and together with our FDA consultants and lawyers we are moving forward with this new and exciting technology."
Sarah Young, Director of Intellicell Biosciences Laboratory stated, "I am thrilled to be part of the Intellicell Bioscience team to advance the science of SVFs. I left Gainesville Florida to join the team in New York because I believed I can be a valuable addition and saw the vision of Dr Victor. The SVF cells will help change the way patients are treated in the future."
Dr. Victor stated, "The field of regenerative medicine especially using the stromal vascular cells that we harvest from the blood vessels in the adipose tissue should be regulated and we believe that the FDA cGMPs of the laboratories are an important part of this. No physician should use any SVF cells that are not processed under strict cGTPs otherwise they are risking the safety of their patients."
About IntelliCell BioSciences
IntelliCell is a pioneering regenerative medicine company focused on the expanding regenerative medical markets using adult autologous vascular cells (SVC's) derived from the blood vessels in the adult adipose tissue. IntelliCell Biosciences has developed its own patent pending protocol to separate adult autologous vascular cells from adipose tissue without the use of enzymes. IntelliCell will also be seeking to develop technology-licensing agreements with technology developers, universities, and international business entities.
About Biologics Consultant Group
Biologics Consulting Group, Inc. (BCG) is a team of consultants who provide national and international regulatory and product development advice on the development and commercial production of biological, drug and device products. Our staff consists of experts in regulatory affairs, product manufacturing and testing, pharmacology/toxicology, facility inspections, statistics, program management, and clinical trial design and evaluation. Many of our consultants are former CBER, CDER, and CDRH reviewers, certified FDA inspectors, and senior scientists from the biotechnology industry.
BCG was founded on the realization that the regulatory process for biological products differs significantly from that for drugs and medical devices, and requires specific expertise based on the unique biochemical nature of the products. While the FDA and ICH regulatory guidance documents provide a necessary framework for biotechnology product development strategies, practical regulatory and operations experience is a vital part of successful licensure and post-market support.
Today, Biologics Consulting Group, Inc. specializes not only in the preparation and review of CBER regulatory applications (INDs and BLAs) as well as the inspection/audit of biologics manufacturing facilities but also in similar regulatory activities for drugs, device and combination products. Because of our familiarity with FDA expectations we have an excellent reputation at the Agency for filing high-quality, easily reviewable applications.
Certain statements set forth in this press release constitute "forward-looking statements." Forward-looking statements include, without limitation, any statement that may predict, forecast, indicate, or imply future results, performance or achievements, and may contain the words "estimate," "project," "intend," "forecast," "anticipate," "plan," "planning," "expect," "believe," "will likely," "will reach," "will change," "will soon," "should," "could," "would," "may," "can" or words or expressions of similar meaning. Such statements are not guarantees of future performance and are subject to risks and uncertainties that could cause the company's actual results and financial position to differ materially from those included within the forward-looking statements. Forward-looking statements involve risks and uncertainties, including those relating to the Company's ability to grow its business. Actual results may differ materially from the results predicted and reported results should not be considered as an indication of future performance. The potential risks and uncertainties include, among others, the Company's limited operating history, the limited financial resources, domestic or global economic conditions, activities of competitors and the presence of new or additional competition, and changes in Federal or State laws. More information about the potential factors that could affect the Company's business and financial results is included in the Company's filings, available via the United States Securities and Exchange Commission.
SOURCE IntelliCell BioSciences, Inc.