NeoStem, Inc.'s Subsidiary Progenitor Cell Therapy Receives FACT Accreditation for Its New Allendale, New Jersey Manufacturing Facility
Published: Apr 13, 2011
ALLENDALE, N.J., April 13, 2011 /PRNewswire/ -- Progenitor Cell Therapy (PCT), a wholly owned subsidiary of NeoStem, Inc. (NYSE Amex: NBS) and an internationally recognized cell therapy services and development company, announced today that it has, once again, demonstrated compliance with the FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing and Administration, and has earned FACT accreditation for its processing facilities through October 19, 2013 based on inspections by FACT at PCT's facilities in Allendale, New Jersey and Mountain View, California. FACT-JACIE standards were developed in 2006 by the Foundation for the Accreditation of Cellular Therapy and the Joint Accreditation Committee of the International Society for Cellular Therapy (ISCT) and the European Group for Blood and Marrow Transplantation (EBMT).
"We recognize that clients put a great deal of trust in PCT when they share their most critical responsibilities of product manufacturing by contracting with PCT. We believe that PCT's track record of quality, timeliness and execution speaks for itself," said Dr. Robin Smith, Chief Executive Officer of NeoStem.
With plans to rapidly expand the manufacturing and storage business to drive revenues from cell therapy clients as well as internal therapeutic development, FACT accreditation for PCT is critical to promote quality medical and laboratory practice of cellular therapy through its peer-developed standards and voluntary inspection and accreditation program. Adherence to such high standards further ensures cell stability and viability and batch consistency for the development of a cell therapy product.
PCT has been FACT accredited at its Mountain View, California facility and now at its new, state-of-the-art facility located in Allendale, New Jersey. Additionally, PCT has obtained AABB accreditation in the category of "Cord Blood Activities Processing, Storage and Distribution" for its New Jersey facility.
"We are very proud to have the endorsement of FACT and of other leading regulatory bodies demonstrating that PCT is meeting the highest standard of quality medical and laboratory practice. This level of accreditation, the highest in our industry, allows us to represent to our clients and prospective clients that doing business with PCT accelerates the pathway toward commercialization of their cell therapy products in the most cost-effective manner," says Robert A. Preti, Ph.D., PCT's President and Chief Scientific Officer.
FACT conducted an on-site evaluation of PCT. The accreditation process involved the submission of documentation to demonstrate compliance to standards and subsequent on-site inspections conducted by inspectors qualified by training and experience in cellular therapy.
PCT serves the developing cell therapy industry that includes biotechnology, pharmaceutical and medical products companies, health care providers and academic investigators from licensed, state-of-the-art cell therapy manufacturing facilities in Allendale, New Jersey and Mountain View, California. PCT supports the research of leading academic investigators designed to expedite the broad clinical application of cell therapy. PCT's core strategy is to provide an international network of cell therapy manufacturing and storage facilities and an integrated and regulatory compliant distribution capacity for the evolving cell therapy industry to meet international commercial demands.
For more information, please visit us at www.progenitorcelltherapy.com.
About NeoStem, Inc.
NeoStem, Inc. is an international biopharmaceutical company with adult stem cell operations in the U.S., a network of adult stem cell therapeutic providers in China, as well as a 51% ownership interest in a profitable Chinese generic pharmaceutical manufacturing company. NeoStem is focused on accelerating the development of proprietary cellular therapies and becoming a single source for collection, storage, manufacturing, therapeutic development and transportation of cells for cell based medicine and regenerative science globally. The Company also has licensed various cellular therapy technologies, including worldwide exclusive licenses to a wound healing technology and to VSEL technology which uses very small embryonic-like stem cells, which are adult stem cells that have been shown to have several physical characteristics that are generally found in embryonic stem cells.
For more information, please visit us at www.neostem.com.
In December 1994, the International Society for Cellular Therapy (ISCT) and the American Society for Blood and Marrow Transplantation (ASBMT) merged their Standards into a single document covering all aspects of hematopoietic cell therapy (collection, processing, and transplantation). The two societies established FACT in order to develop a voluntary Inspection and Accreditation Program based on the joint Standards. FACT promotes quality medical and laboratory practice of cellular therapy through its peer-developed standards and voluntary inspection and accreditation program.
In 2006, FACT, in collaboration with the Joint Accreditation CommitteeISCT & EBMT (JACIE), developed international standards in the field of cellular therapy. JACIE was founded by the European Group for Blood and Marrow Transplantation (EBMT) and the International Society for Cellular Therapy (ISCT), the two leading scientific organizations involved with cellular transplantation in Europe.
The FACT Inspection and Accreditation Program was developed by Dr. Phyllis Warkentin, FACT Medical Director, the FACT Directors and Officers, as well as the ISCT and ASBMT Regulatory and Standards Committees. The first edition of the FACT Standards was published in September 1996, and the first inspections began in September of 1997 with the first programs awarded accreditation in 1998.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management's current expectations, as of the date of this press release, and involve certain risks and uncertainties. Forward looking statements include statements herein with respect to the ability of PCT's business to complement NeoStem (the "Company")'s adult stem cell operations and successful execution of the Company's strategy, as well as other advances in the Company's business, about which no assurances can be given. The Company's actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. Factors that could cause future results to materially differ from recent results or those projected in forward-looking statements include the "Risk Factors" described in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on April 7, 2011, as well as other periodic filings made with the Securities and Exchange Commission. The Company's further development is highly dependent on future medical and research developments and market acceptance, which is outside its control. The Company may experience difficulties in integrating PCT's business and could fail to realize potential benefits of the merger. Acquisitions may entail numerous risks for the Company, including difficulties in assimilating acquired operations, technologies or products, and the loss of key employees from acquired businesses.
For more information, please contact:
Robin Smith, CEO
SOURCE NeoStem, Inc.