ALLENDALE, N.J., Dec. 8, 2014 (GLOBE NEWSWIRE) -- NeoStem, Inc. (Nasdaq:NBS) (“NeoStem” or the “Company”), a biopharmaceutical company developing novel cell based therapeutics, and its subsidiary, Progenitor Cell Therapy, LLC (“PCT”), announced today that PCT has been awarded re-accreditation by AABB (formerly known as the American Association of Blood Banks) in the category of “Cell Therapy Activity: Cord Blood – Processing, Storage and Distribution” for its Allendale, NJ facility. Accreditation follows an intensive on-site assessment by specially trained AABB assessors and establishes that the level of technical and administrative performance within the facility meets or exceeds the standards set by AABB.
“PCT continues to offer high-quality manufacturing services and expertise to cell therapy clients, and the AABB accreditation is a testament to the safety and high standards at its Allendale facility that clients have come to expect,” said Dr. Robin Smith, Chief Executive Officer of NeoStem.
AABB’s Accreditation Program contributes to the quality and safety of collecting, processing, testing, distributing and administering blood and cellular therapy products. The Accreditation Program assesses the quality and operational systems in place within a facility. The basis for assessment includes compliance with AABB Standards, Code of Federal Regulations and federal guidance documents.
PCT originally announced that it had earned AABB accreditation in April 2011, when it also announced FACT accreditation for its Allendale facility. 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). AABB has been a leader in the development of standards for voluntary compliance since 1957, when the first edition of Standards for Blood Banks and Transfusion Services was published.
“We are pleased that this AABB reaccreditation serves as a reaffirmation of PCT’s continued dedication to safety and compliance as we continue to work towards commercial scale manufacturing capabilities while providing high quality, reliable service to all of our clients,” said Robert A. Preti, Ph.D., PCT’s President and Chief Scientific Officer.
About PCT
Progenitor Cell Therapy (PCT), a wholly owned subsidiary of NeoStem, Inc., is a leading contract development and manufacturing organization in the cellular therapy industry. For over 15 years, PCT has provided pre-clinical and clinical cGMP development and manufacturing services to more than 100 clients, advancing regenerative medicine product candidates from the development stage all the way through to human testing. PCT has two cGMP-compliant, state-of-the art facilities in New Jersey and California to serve the cell therapy industry and offers manufacturing of cell therapy-based products, engineering and innovation services, process and product development, cell and tissue processing, collection and storage, regulatory consulting, facility design, validation, and due diligence evaluations. www.pctcelltherapy.com
About NeoStem, Inc.
NeoStem is a biopharmaceutical company pursuing the preservation and enhancement of human health globally through the development of cell based therapeutics that prevent, treat or cure disease by repairing and replacing damaged or aged tissue, cells and organs and restoring their normal function. The business includes the development of novel proprietary cell therapy products as well as a revenue-generating contract development and manufacturing service business. This combination has created an organization with unique capabilities for cost effective in-house product development and immediate revenue and cash flow generation. www.neostem.com
About AABB
Established in 1947, AABB (formerly known as the American Association of Blood Banks) is an international, not-for-profit association dedicated to the advancement of science and the practice of transfusion medicine and related biological therapies. The association is committed to improving health by developing and delivering standards, accreditation and educational programs and services to optimize patient and donor care and safety. For more information, visit www.aabb.org.
Forward-Looking Statements
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 successful execution of the Company’s business strategy, the Company’s ability to develop and grow its business, the successful development of cellular therapies with respect to the Company’s research and development and clinical evaluation efforts in connection with the Company’s Targeted Immunotherapy Program, Ischemic Repair Program (including NBS10 for AMI), Immune Modulation Program and other cell therapies, the future of the regenerative medicine industry and the role of stem cells and cellular therapy in that industry, and the performance and planned expansion of the Company’s contract development and manufacturing business. 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 the 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 (“SEC”) on March 13, 2014, the Company’s Current Report on Form 8-K filed with the SEC on May 8, 2014 and in the Company’s other periodic filings with the SEC. The Company’s further development is highly dependent on future medical and research developments and market acceptance, which is outside of its control.
CONTACT: Investor Contact: LifeSci Advisors, LLC Hans Vitzthum Managing Director Phone: +1-212-915-2568 Email: hans@lifesciadvisors.com Media Contact: NeoStem, Inc. Eric Powers Manager of Communications and Marketing Phone: +1-212-584-4173 Email: epowers@neostem.com
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