Date: 2016-11-22
Type of information: Validation of a production plant
Compound:
Company: PCT, a Caladrius Company (USA - CA)
Therapeutic area: Technology - Services
Type agreement: validation of a production plant
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Disease:
Details: * On November 22, 2016, Caladrius Biosciences 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.
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