Hackensack, NJ/Mountain View, CA (PRWEB) January 7, 2008
Progenitor Cell Therapy, LLC (PCT) announced today that it has obtained a renewal of FACT accreditation for its Hackensack, New Jersey facility, in addition to gaining first-time accreditation of its facility in Mountain View, California. FACT accreditation is granted for a three-year term upon satisfactorily passing a facility and systems audit by a certified FACT inspector.
"Over the last year," states Marie DeVito, MS, PCT's Senior Director of Quality Assurance and Quality Control, "PCT's facilities and systems were the subject of many client audits, including several inspections by Qualified Persons and against EU GMPs, other staff-conducted internal audits, and several externally-conducted internal audits, in addition to the FACT inspections. FACT accreditation is one part of our overall commitment to meet the highest quality and regulatory compliance in the cell therapy industry."
In addition to FACT accreditation, PCT's Mountain View facility maintains a drug manufacturing license, which it has held since 2002 with the Food & Drug Branch of the state of California. PCT's Hackensack facility maintains a Clinical Laboratory License and a license for hematopoietic progenitor cell processing with the New York State Board of Health and with the State of Maryland, a Blood Bank License with the New Jersey Department of Health and Senior Services, and a CLIA license with the Clinical Laboratory Improvement Amendments of the Centers for Medicare & Medicaid Services (CMS).
Both PCT facilities also maintain a biologics license with the state of California Department of Health and are registered with the FDA for the manufacture of Human Cells, Tissues, and Cellular and Tissue-Based Products. PCT's quality systems are compliant with FDA's cGMP and cGTP regulations in addition to client-specific SOPs, processes, methods and specifications as appropriate.
PCT has also recently applied for AABB certification of its Hackensack facility in conjunction with its active cord blood processing business. Making it one of the few cord blood processing facilities to do so, PCT processes and stores cord blood in compliance with cGMP standards. Clients include DomaniCell (http://www.domanicell.com) and the cord blood companies of Cord Blood America, Inc including CorCell (http://www.corcell.com).
The Foundation for the Accreditation of Cellular Therapy (FACT) promotes quality medical and laboratory practice of cellular therapy through its peer-developed standards and voluntary inspection and accreditation program.
About Progenitor Cell Therapy, LLC.
Progenitor Cell Therapy, LLC (PCT) is a client-based company providing cell therapy service solutions for the research, development, manufacturing and commercialization of cell-based therapies. With its cell therapy manufacturing facilities and team of experienced professionals, PCT provides current Good Manufacturing Practices (cGMP)-compliant services for pre-clinical and clinical development, manufacturing, and eventual commercialization of cellular therapies for clients throughout the world. For more information, please visit http://www.progenitorcelltherapy.com.
George S. Goldberger, Chief Business Officer
This press release does not constitute an offer to sell, or a solicitation of any offer to buy any securities of Progenitor Cell Therapy. In addition, certain of the statements in this press release are forward-looking statements relating to such matters as anticipated financial performance, business prospects, technological developments, new products, research and development activities and similar matters. These statements involve known and unknown risks, uncertainties, and other factors that may cause the company or its industry's actual results, levels of activity, performance, or achievements to be materially different from any future results, levels of activity, performance, or achievements expressed or implied by such forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "may," "intend," "will," "should," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential" or "continue" or the negative of such terms or other comparable terminology. Forward-looking statements are only predictions. Actual events or results may differ materially. Although the company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity, performance or achievements. Moreover, neither the company nor any other person assumes responsibility for the accuracy and completeness of such statements. The company is under no duty to update any of the forward-looking statements after the date of this press release to conform such statements to actual results.