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.
Forward-Looking
Statements
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.
Contacts:
IntelliCell BioSciences, Inc.
Rubenstein Investor Relations
Contact: Tim
Clemensen
Email Contact:
TClemensen@rubensteinir.com
(212) 843-9337
Steven Victor MD
IntelliCell BioSciences
Chairman/CEO
460 Park Avenue 17th Floor
New York, New York
10022
212-249-3050
Fax 212-249-1482
Cell 917-459-8252
www.IntelliCellBioSciences.com
Rhodesvictor@aol.com
SOURCE IntelliCell BioSciences, Inc.