title: Real-time process/quality control for HPC processing.
abstract: BACKGROUND
  JACIE Standards (FACT Standards in the USA) have been implemented in Europe since 1999. An on-site accreditation inspection took place at our center in January 2004. The purpose of this work was to develop a real-time process/quality control system meeting the JACIE Standards for HPC release.
  
  
  METHODS
  Data from 194 HPC processing procedures for autologous transplantation performed over a 5-year period were analyzed. The results of different processing methods applied at our facility were compared: (1) cryopreservation without washing cells (n=50), (2) washing cells (n=87), (3) cell-density separation (n=12) and (4) positive CD34 selection (n=45).
  
  
  RESULTS
  Four critical control points were set for the validation of HPC processing: (a) number of lost CD34(+) cells during processing, (b) contamination, (c) viability of the cells after thawing and (d) ability to reconstitute hematopoiesis after transplantation. On the basis of statistical analysis, ranges of acceptable values were defined for each critical control point and for each processing method. Those acceptable values were used for cell release and real-time quality control.
  
  
  CONCLUSIONS
  This study describes a model for the validation of HPC processing and for a real-time process/quality control system for HPC release. Optimization of processing techniques, standardization of methods and comparison between facilities will open the way towards external quality controls and quality improvement.
authors.affiliation: Hematology Department, University Hospital Inselspital, Berne, Switzerland.
authors.forename: M
authors.initials: M
authors.lastname: Arpagaus
authors.forename: E Oppliger
authors.initials: EO
authors.lastname: Leibundgut
authors.forename: K
authors.initials: K
authors.lastname: Zbären
authors.forename: C
authors.initials: C
authors.lastname: Brunold
authors.forename: E
authors.initials: E
authors.lastname: Ischi
authors.forename: A
authors.initials: A
authors.lastname: Tobler
authors.forename: C
authors.initials: C
authors.lastname: Zwicky
mesh_terms: D018952:Antigens, CD34 / Q000032:analysis; D015925:Cryopreservation; D018380:Hematopoietic Stem Cell Transplantation / Q000592:standards*; D006801:Humans; D011786:Quality Control; D013997:Time Factors; D014182:Transplantation, Autologous
chemical_list: D018952:Antigens, CD34