AABB Accreditation is of particular importance to our cord blood banking clients and the parents who choose to bank their child's cord blood stem cells with them
Hackensack, NJ (PRWEB) September 10, 2008
Progenitor Cell Therapy, LLC (PCT) announced today that it has obtained AABB accreditation in the category of 'Cord Blood Activities - Processing, Storage, Distribution'.
The AABB accreditation was granted retroactive to 1 April 2008 after satisfactorily passing an intensive on-site assessment by a certified AABB assessor establishing that the level of medical, technical and administrative performance within the facility meets the standards set by AABB. By successfully meeting those requirements, PCT joins approximately 1,800 accredited facilities around the world.
"PCT sought AABB Accreditation because the program sets a standard for facilities around the world to achieve and maintain excellence by promoting a level of professional and medical expertise that contributes to quality performance," stated Marie DeVito, MS, PCT's Senior Director of Quality Assurance and Quality Control.
PCT's facilities and systems are regularly the subject of client audits, including inspections by external quality and regulatory specialist consultants, in addition to audits conducted by accreditation agencies such as the Foundation for Accreditation of Cellular Therapy (FACT).
"AABB Accreditation is of particular importance to our cord blood banking clients and the parents who choose to bank their child's cord blood stem cells with them," states PCT President & Chief Scientific Officer, Dr. Robert A. Preti. "While such accreditation is an important baseline, we believe our program already exceeds most industry standards. PCT is one of the few cord blood processing facilities in the world to process and store cord blood in compliance with the FDA's cGMP (Current Good Manufacturing Practices) standards. We believe this provides a significant advantage to future usability of these cord blood stem cells."
In addition to AABB accreditation, PCT's New Jersey 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). PCT's California facility maintains a drug manufacturing license, which it has held since 2002 with the Food & Drug Branch of the state of California.
Both PCT facilities also maintain FACT Accreditation, 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.
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.
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