VaxArray Flu Vaccine Potency Study Published in Vaccine

InDevR’s Study, “VaxArray Assessment of Influenza Split Vaccine Potency and Stability” published in Vaccine

BOULDER, Colo.–(BUSINESS WIRE)–InDevR, Inc., an innovative life science company dedicated to improving biopharmaceutical and vaccine manufacturing, announced study results and publication of “VaxArray Assessment of Influenza Split Vaccine Potency and Stability” in the pre-eminent journal Vaccine.

In the study, the VaxArray Seasonal HA potency assay exhibited good overall accuracy, precision, and stability indication properties when compared to single radial immunodiffusion assay (SRID/SRD) for both monobulk intermediates and multivalent split-virus flu vaccines from the 2015-2016 flu season. Relative to SRD, VaxArray exhibited a number of advantages, including speed (time to result 2 hrs vs. 48 hrs), off-the-shelf availability, greater sensitivity, wider linear dynamic range, and application to in-process samples. This work establishes VaxArray as a promising alternative to SRD in vaccine potency determination.

The VaxArray assay is the first commercially available kit for rapid quantification of flu vaccine potency. The current gold standard method (SRD) is tedious and time-consuming, requiring hours of skilled hands on time for analysis. To conduct SRD, each laboratory must obtain all of the materials to create immunodiffusion gels, thus analysis can be inconsistent between laboratories. In contrast, VaxArray reagent kits are produced under ISO 13485:2003 quality management systems and are available for immediate use. Because VaxArray is off-the-shelf, the assay can be used at all stages of flu vaccine development, from the “seed lab” where virus growth is optimized, throughout all purification, concentration, and formulation steps.

“This study represents the first published results for VaxArray applied to a commercially available split-virus flu vaccine. An exciting message of the VaxArray story is that it can help manufacturers improve their development and characterization of vaccines, even in the upstream processes that involve challenging conditions,” said Kathy Rowlen, Chief Executive Officer of InDevR.

Development of the VaxArray Influenza product was supported in part by SBIR Phase I and II grants from the National Institute of Allergy and Infectious Diseases (NIAID). In addition to VaxArray for seasonal flu vaccines, InDevR is developing advanced versions of the assay for use with potential pandemic strains of influenza, for high throughput applications and even neuraminidase quantification. The VaxArray platform can also be adapted for other vaccines. According to Rowlen, “With appropriate changes to the reagents, the VaxArray platform could be used to determine potency for any vaccine. For example, in response to recent outbreaks, we are now exploring application of VaxArray to Ebola, Zika and other vaccines.”

VaxArray Influenza potency assay is available as a testing service or a product kit. More information is available at: VaxArray™ Influenza.

About the Study:

“VaxArray Assessment of Influenza Split Vaccine Potency and Stability,” by Laura R. Kuck, Ph.D.; Stephen Saye; Sam Loob; Sylke Roth-Eichhorn, Ph.D.; Rose Byrne-Nash, Ph.D.; Kathy L. Rowlen, Ph.D.: http://www.sciencedirect.com/science/article/pii/S0264410X17302220 published by Elsevier JVAC-D-16-01994R1 (now JVAC 18403) doi: 10.1016/j.vaccine.2017.02.028

About InDevR:

InDevR has a demonstrated commitment to innovative solutions for the life science industry. With focus on enhancing bioprocessing for vaccines and other biotherapeutics, InDevR has emerged as a leader in progressive new analytical technologies that enable accelerated development and manufacturing of these life-saving products. For more information about the company and products, please visit www.indevr.com or call 303-402-9100.

About Vaccine:

Vaccine is the pre-eminent journal for those interested in vaccines and vaccination. It is the official journal of The Edward Jenner Society and The Japanese Society for Vaccinology and is published by Elsevier www.elsevier.com/locate/vaccine

Copies of this paper are available to credentialed journalists upon request; please contact Elsevier’s Newsroom at newsroom@elsevier.com or +31 20 485 2492

HHS is not responsible for the contents of this release. The statements contained in this release do not constitute endorsement or recommendation by the U.S. Government or HHS.