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Bioanalysis. 2016 Dec;8(24):2523-2535.

A semi-universal assay platform to quantitate vaccines with potential applications for biotherapeutics.

Author information

1
Merck & Co., Inc., 770 Sumneytown Pike, PO Box 4, West Point, PA 19486, USA.

Abstract

AIM:

Biologics development often requires multiple immunoassays to evaluate both assay reagents and potential drug candidates resulting in extensive analytical development.

METHODOLOGY:

We developed a semi-universal, 5-layer platform assay on Gyrolab using secondary antispecies or anti-isotype-specific capture and detection antibodies. We applied the assay to several multivalent vaccines.

RESULTS:

Method performance exhibited a median accuracy of 110%, reproducibility of 9% CV and intermediate precision of 11% CV. System suitability criteria were met for 92.5% of the samples and only one out of 31 replicate samples exhibited a %CV greater than 20%.

CONCLUSION:

The semi-universal Gyrolab assay allowed assay development without reagent labeling. The format could also be translated into a plate-based assay.

KEYWORDS:

ELISA; Gyrolab; parallel line analysis; polysaccharides

PMID:
27884078
DOI:
10.4155/bio-2016-0148
[Indexed for MEDLINE]

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