[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 (74 downloads)  

 

[Press Release] VaxArray Potency Kit for “Pandemic” Vaccines Fills Gap in Pandemic Preparedness

InDevR’s game-changing VaxArray potency test for influenza H5, H7, and H9 vaccines published in npj Vaccines

BOULDER (10/8/18) — The development of vaccines against potentially pandemic influenza strains is a critical component of the global response to an influenza pandemic. However, the tests needed to determine the potency of pandemic vaccines often represent a bottleneck delivering those vaccines when they can be most effective. Immediate access to a potency assay for monitoring of immunogenic HA concentrations would streamline the development, production, release, and ongoing stability monitoring of pandemic vaccines.  InDevR’s recent publication describes the development and performance of the VaxArray Influenza Pandemic HA potency assay for vaccines containing H5, H7, and H9 subtypes:  Byrne-Nash, R. T. et al. VaxArray potency assay for rapid assessment of “pandemic” influenza vaccines. npj Vaccines https://doi.org/10.1038/s41541-018-0080-6 (2018).

“With the 100^th year anniversary since the 1918 influenza pandemic, there has been much discussion at every level of government and within the global vaccine industry about the gaps that remain in our ability to rapidly respond to deadly pandemic.  We have addressed a critical gap with this new potency test.  The VaxArray platform represents a breakthrough that could significantly streamline delivery of safe and efficacious influenza vaccines in the event of a pandemic,” said InDevR’s CEO Dr. Kathy Rowlen.

The assay demonstrated high sensitivity, accuracy, precision, and detection of a large panel of influenza viruses with pandemic potential spanning 16 years of antigenic drift, including the most recent pre-pandemic vaccine being developed against the “5^th wave” A/H7N9 virus. The assay was also shown to be compatible with low dose and adjuvanted vaccines as well as upstream crude in-process samples, which would allow manufacturers to use the test to optimize yield.  The VaxArray system outperformed the current labor- intensive assay for influenza vaccine potency, SRID, in terms of sample-to-result time (2 hours versus 2 days), limit of detection, sensitivity, and compatibility with crude and adjuvanted samples.

According to Dr. Nancy Cox, retired former director of the Influenza Division within the Centers for Disease Control and Prevention, “History has taught us that time is of the essence when it comes to making pandemic influenza vaccines available to the public. The VaxArray assay represents a breakthrough in reducing a key bottleneck that has slowed vaccine delivery during past influenza pandemics, including the 2009 H1N1 pandemic.  Reducing bottlenecks in pandemic vaccine production allows earlier vaccine administration which will result in fewer illnesses, hospitalizations, and deaths.”

Find more information about the complete VaxArray product line at: https://indevr.com/products/vaxarray/

This work was sponsored as part of the Department of Health and Human Services’ inter-agency Influenza Vaccine Improvement Initiative.  Specifically, product development was supported by a Small Business Innovation Research grant R44AI102318 through 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.

MEDIA CONTACT

Shannon Rodriguez

InDevR

+1-303-402-9100

rodriguez@indevr.com