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

Ambrosia Garcia1, Sarah Keinonen1, Ana M Sanchez1

  • 1Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.

Journal of Immunological Methods
|June 15, 2014
PubMed
Summary
This summary is machine-generated.

External proficiency testing programs for clinical trials require large, well-characterized samples. Leukapheresis cryopreservation effectively provides these essential cellular materials, ensuring quality assurance for vaccine and therapeutic studies.

Keywords:
LeukapheresisLeukocytesPBMCProficiency testing

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Area of Science:

  • Clinical Laboratory Science
  • Biotechnology
  • Immunology

Background:

  • External proficiency testing is crucial for clinical trial quality assurance.
  • Good Clinical Laboratory Practice (GCLP) guidelines mandate assay validation and proficiency testing.
  • Well-characterized test samples are essential for effective proficiency testing programs.

Purpose of the Study:

  • To describe a leukapheresis cryopreservation program.
  • To evaluate its ability to provide sufficient, functional cellular samples for external proficiency testing.
  • To support quality assurance in vaccine and therapeutic clinical trials.

Main Methods:

  • Implementing a coordinated leukapheresis collection, processing, and cryopreservation protocol.
  • Ensuring sample processing within an 8-hour timeframe.
  • Utilizing samples from a large master set for distribution to participating laboratories.

Main Results:

  • The leukapheresis program successfully preserved the functionality of cellular subsets.
  • The program generated the necessary sample quantities for an external proficiency testing program.
  • This approach enables monitoring of laboratory performance over time and across sites.

Conclusions:

  • Leukapheresis is an effective method for generating large numbers of high-quality cellular samples.
  • Cryopreservation maintains cellular functionality, supporting robust external proficiency testing.
  • This program enhances the reliability and quality of clinical trial laboratory performance.