Clinical validation of the FluChip-8G Influenza A+B Assay for influenza type and subtype identification

published in Journal of Clinical Virology

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Analytical Evaluation of the Microarray-Based FluChip-8G Influenza A+B Assay

published in Journal of Virological Methods

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[Press Release] New VaxArray Neuraminidase Potency Test for N9

InDevR launches first-in-class reagent kit for rapid quantification of N9 in

 “pandemic” influenza vaccines.

 

BOULDER COLORADO (3/26/19) — InDevR Inc. announced commercial availability of a VaxArray reagent kit for neuraminidase (NA) from influenza viruses containing the N9 subtype.  Together with InDevR’s VaxArray reagent kit for “pandemic” hemagglutinin (H5, H7, H9), the new N9 reagent kit can provide unprecedented insight into the relationship between influenza vaccine antigen content and clinical efficacy for vaccines to be included in the nation’s emergency stockpile.

The level of neuraminidase in flu vaccines is not currently regulated but its “presence and type must be confirmed by suitable enzymatic or immunological methods” during vaccine manufacturing.  The portfolio of VaxArray NA reagents kits, which include the only commercially available potency tests for N9, N1, N2, and B-NA, can be used to efficiently address both identity and presence of NA in flu vaccines manufactured by egg, cell, or recombinant technology.  The VaxArray assays are subtype specific, quantitative, correlated with enzymatic activity, stability indicating, and can serve as a proxy for immunogenicity.

The VaxArray neuraminidase assays are expected to reduce the time and cost associated influenza vaccine production as well as facilitating improvement of influenza vaccines.

“Improving our understanding the role of neuraminidase is an important component of this effort of improving influenza vaccines. Together with studying the immune response elicited by influenza vaccines against HA, we are interested in understanding the potential contribution of NA, as we believe this might lead to more effective seasonal and pandemic influenza vaccines.  Indeed, we are currently exploiting the VaxArray platform to characterize the NA content in a pre-pandemic whole virion H5N1 vaccine candidate.”

said Dr. Kutub Mahmood, Scientific Director at PATH.    

InDevR also offers VaxArray potency assays for influenza seasonal hemagglutinin and nucleoprotein. Find more information about the entire VaxArray product line at: https://indevr.com/products/vaxarray/

Development of the VaxArray platform was sponsored as part of the Department of Health and Human Services’ inter-agency Influenza Vaccine Improvement Initiative through a Small Business Innovation Research grant R44AI102318 from the National Institute of Allergy and Infectious Diseases, which is part of the National Institutes of Health (NIH).  The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

 

About InDevR

InDevR is a global leader in progressive new analytical technologies that enable accelerated development and manufacturing of vaccines and other biotherapeutics.  For more information about the company and products, please visit www.indevr.com or call 303-402-9100.

About PATH

PATH is a non-profit organization working toward sustainable production of high-quality, affordable seasonal and pandemic influenza vaccines in developing countries – including innovative broadly protective influenza vaccines.

 

MEDIA CONTACT

Shannon Rodriguez

InDevR

+1-303-402-9100

rodriguez@indevr.com

 

 

New npj Vaccines Paper on Influenza Neuraminidase Potency

Open Full Publication Byrne-Nash_et_al-2019-npj_Vaccines-SM.pdf (140 downloads)