Cellular Biomedicine Group's Shanghai Facility Passes Fourth Consecutive CFDA Inspection
April 06 2015 - 9:00AM
Cellular Biomedicine Group Inc. (Nasdaq:CBMG) ("CBMG" or the
"Company"), a biomedicine firm engaged in the development of
effective treatments for degenerative and cancerous diseases, today
announced that its GMP laboratory and production facility in
Shanghai has successfully passed a fourth consecutive China Food
and Drug Administration (CFDA) inspection.
Operating since 2012, the 20,000 square foot facility has
consistently been certified by a third-party CFDA authorized
accreditation agency each year. Additionally, in order to maintain
international standards, the cleanroom facility undergoes a
top-to-bottom annual calibration and validation process from
ISO-accredited agencies, and has received and maintained an
ISO-14644 cleanroom certification. Under the leadership of Helen
(Li) Zhang, Vice President of Technology and Manufacturing, the GMP
facility adheres to the highest standards in order to ensure
contaminant-free production rooms, employee and patient safety and
quality control. Ms. Zhang, formerly the associate director of cGMP
and laboratory operations at the Gene Therapy Initiative of Harvard
Medical School, Boston, has more than 11 years' experience in cGMP
establishment and management, as well as in large-scale
manufacturing of clinical grade cell therapy products that meet FDA
standards.
"Having established a world-class biomedicine facility in
Shanghai, China, and in response to the vibrant development in the
cellular therapeutic industry, we plan to expand our GMP facilities
for a total facility production space of 57,000 square feet by June
of 2015," said William (Wei) Cao, PhD, BM, Chief Executive Officer
of Cellular Biomedicine Group. "This expansion will allow us to be
prepared for increasing manufacture demand from our immuno-oncology
and human adipose-derived mesenchymal progenitor cell (haMPC)
platforms in the near future. In addition, housing our vertically
integrated research and development and production systems in
several locations enables the Company to deliver consistent quality
measures across various territories in China, thereby better
serving the Company's patient population."
About Cellular Biomedicine Group
Cellular Biomedicine Group, Inc. develops proprietary cell
therapies for the treatment of certain degenerative diseases and
cancers. Our developmental stem cell, progenitor cell, and immune
cell projects are the result of research and development by
scientists and doctors from China and the United States.
Our flagship GMP facility, consisting of eight independent cell
production lines, is designed, certified and managed according to
U.S. standards. To learn more about CBMG, please visit:
www.cellbiomedgroup.com
Forward-Looking Statements
Statements in this press release relating to plans, strategies,
trends, specific activities or investments, and other statements
that are not descriptions of historical facts may be
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995, Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended. Forward-looking
information is inherently subject to risks and uncertainties, and
actual results could differ materially from those currently
anticipated due to a number of factors, which include, but are not
limited to, risk factors inherent in doing business.
Forward-looking statements may be identified by terms such as
"may," "will," "expects," "plans," "intends," "estimates,"
"potential," or "continue," or similar terms or the negative of
these terms. Although CBMG believes the expectations reflected in
the forward-looking statements are reasonable, they cannot
guarantee that future results, levels of activity, performance or
achievements will be obtained. CBMG does not have any obligation to
update these forward-looking statements other than as required by
law.
CONTACT: Sarah Kelly
Director of Corporate Communications, CBMG
+1 650 566-5064
sarah.kelly@cellbiomedgroup.com
Vivian Chen
Managing Director Investor Relations, Grayling
+1 347-481-3711
vivian.chen@grayling.com
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