Caladrius Biosciences (CLBS) Unit Earns FACT re-Accreditation

November 22, 2016 7:35 AM EST
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Caladrius Biosciences, Inc. (Nasdaq: CLBS) announced that PCT, its cell therapy contract development and manufacturing subsidiary, has earned re-accreditation by the Foundation for the Accreditation of Cellular Therapy (“FACT”). This accreditation confirms that PCT operates in compliance with the FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing and Administration at both its Allendale, New Jersey and Mountain View, California sites.

FACT is an internationally recognized accrediting body for hospitals and medical institutions involved with stem cell transplant, and accreditation indicates that the reviewed institution has met the most rigorous standards in every aspect of hematopoietic stem cell therapy. This covers the entire spectrum of stem cell therapy, from clinical care to donor management, cell collection, processing, storage, transportation, administration, and cell release. FACT-JACIE Standards are defined by leading experts based on the latest knowledge of the field of cellular therapy transplantation.

With its initial accreditation in 2000, PCT was the first cell therapy manufacturing organization to ever receive FACT Accreditation and it has consistently earned re-accreditation upon periodic review in the intervening years.

“We are delighted to maintain our FACT accreditation as it is an independent affirmation of the high standard met by our Quality Systems. While serving as a point of differentiation for PCT from its competitors in cell therapy contract manufacturing services in the U.S., it most importantly acknowledges our focus on producing the highest quality products for the patients who receive them,” said Robert A. Preti, PhD, President of PCT and Senior Vice President, Manufacturing and Technical Operations and Chief Technology Officer of Caladrius. “By achieving FACT re-accreditation, we are informing patients, medical professionals, health insurance companies and the government that we adhere to the most rigorous standards in patient care and laboratory practices.”



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