Validation of an automated system for aliquoting of HIV-1 Env-pseudotyped virus stocks.

Published online

Journal Article

The standardized assessments of HIV-specific immune responses are of main interest in the preclinical and clinical stage of HIV-1 vaccine development. In this regard, HIV-1 Env-pseudotyped viruses play a central role for the evaluation of neutralizing antibody profiles and are produced according to Good Clinical Laboratory Practice- (GCLP-) compliant manual and automated procedures. To further improve and complete the automated production cycle an automated system for aliquoting HIV-1 pseudovirus stocks has been implemented. The automation platform consists of a modified Tecan-based system including a robot platform for handling racks containing 48 cryovials, a Decapper, a tubing pump and a safety device consisting of ultrasound sensors for online liquid level detection of each individual cryovial. With the aim to aliquot the HIV-1 pseudoviruses in an automated manner under GCLP-compliant conditions a validation plan was developed where the acceptance criteria-accuracy, precision as well as the specificity and robustness-were defined and summarized. By passing the validation experiments described in this article the automated system for aliquoting has been successfully validated. This allows the standardized and operator independent distribution of small-scale and bulk amounts of HIV-1 pseudovirus stocks with a precise and reproducible outcome to support upcoming clinical vaccine trials.

Full Text

Duke Authors

Cited Authors

  • Schultz, A; Germann, A; Fuss, M; Sarzotti-Kelsoe, M; Ozaki, DA; Montefiori, DC; Zimmermann, H; von Briesen, H

Published Date

  • 2018

Published In

Volume / Issue

  • 13 / 1

Start / End Page

  • e0190669 -

PubMed ID

  • 29300769

Pubmed Central ID

  • 29300769

Electronic International Standard Serial Number (EISSN)

  • 1932-6203

Digital Object Identifier (DOI)

  • 10.1371/journal.pone.0190669

Language

  • eng

Conference Location

  • United States