Real-time process/quality control for HPC processing

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. Data...

Full description

Saved in:
Bibliographic Details
Published in:Cytotherapy (Oxford, England) England), 2004-10, Vol.6 (5), p.505-513
Main Authors: Arpagaus, M, Leibundgut, E Oppliger, Zbaren, K, Brunold, C, Ischi, E, Tobler, A, Zwicky, C
Format: Article
Language:English
Subjects:
Antigens, CD34 - analysis
cell processing
cell release
Cryopreservation
FACT
Hematopoietic Stem Cell Transplantation - standards
Humans
JACIE
Quality Control
Time Factors
Transplantation, Autologous
validation
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary: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. 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 =5O), (2) washing cells (n =87), (3) cell-density separation (n =12) and (4) positive CD34 selection (n =45). 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. 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.
ISSN:1465-3249
1477-2566
DOI:10.1080/14653240410005032