New FACT Accreditation Goals to Increase Quality and Advance Research

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Facilities May Pursue Accreditation for Cellular Therapy Product Processing with
+ D; F4 B# i! U8 c7 K7 yMinimal Manipulation, More than Minimal Manipulation, or Both
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8 D4 _! s5 Q$ p, ^- q: L1 y7 YFACT is pleased to announce two new accreditation goals for processing of hematopoietic-derived cells intended for administration to patients. Facilities will be able to seek FACT accreditation for cellular therapy product processing with minimal manipulation, more than minimal manipulation, or both. FACT accreditation for more than minimal manipulation will provide facilities a mechanism to increase the quality of cellular therapy research for many types and uses of hematopoietic-derived cells.
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  Y3 F- i: O7 \( k5 ]- e0 U) tDr. Phyllis Warkentin, FACT's Chief Medical Officer, comments, "FACT is enthusiastic about this effort to advance research in cellular therapy by providing facilities an avenue for external validation and public recognition of their processing of IND or licensed products."& |! b- [6 w7 g& u$ Q; q% U

+ z: {! d7 a  v1 X( s2 aFacilities seeking accreditation for more than minimal manipulation will be inspected for compliance with the FACT-JACIE Part D Processing Facility Standards. Knowledgeable FACT inspectors who have experience with IND products will serve as inspectors for these types of inspections. Their motivation, like FACT’s, is to advance the quality of the research.7 ?& j: H$ D& |; |( T

" f2 i) A0 G& b& n$ L* X& IAccreditation for cellular therapy product processing with minimal manipulation will apply to 361 products, including standard-of-care uses of HPCs., D4 a1 V# j- X1 E' D
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Additional details regarding accreditation of processes for research in cellular therapy and regenerative medicine will be published in the next Just the FACTs newsletter. Please contact the FACT office with any questions regarding this new accreditation. The organization is eager to help facilities achieve this important level of quality to advance promising research.
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