SHANGHAI, China and PALO ALTO, Calif., April 6, 2015 (GLOBE NEWSWIRE) -- 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
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.
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Source:Cellular Biomedicine Group Inc.