Leukopak PBMC sample processing for preparing quality control material to support proficiency testing programs.

Journal Article (Journal Article)

External proficiency testing programs designed to evaluate the performance of end-point laboratories involved in vaccine and therapeutic clinical trials form an important part of clinical trial quality assurance. Good clinical laboratory practice (GCLP) guidelines recommend both assay validation and proficiency testing for assays being used in clinical trials, and such testing is facilitated by the availability of large numbers of well-characterized test samples. These samples can be distributed to laboratories participating in these programs and allow monitoring of laboratory performance over time and among participating sites when results are obtained with samples derived from a large master set. The leukapheresis procedure provides an ideal way to collect samples from participants that can meet the required number of cells to support these activities. The collection and processing of leukapheresis samples require tight coordination between the clinical and laboratory teams to collect, process, and cryopreserve large number of samples within the established ideal time of ≤8 hours. Here, we describe our experience with a leukapheresis cryopreseration program that has been able to preserve the functionality of cellular subsets and that provides the sample numbers necessary to run an external proficiency testing program.

Full Text

Duke Authors

Cited Authors

  • Garcia, A; Keinonen, S; Sanchez, AM; Ferrari, G; Denny, TN; Moody, MA

Published Date

  • July 2014

Published In

Volume / Issue

  • 409 /

Start / End Page

  • 99 - 106

PubMed ID

  • 24928650

Pubmed Central ID

  • PMC4138237

Electronic International Standard Serial Number (EISSN)

  • 1872-7905

Digital Object Identifier (DOI)

  • 10.1016/j.jim.2014.05.019


  • eng

Conference Location

  • Netherlands