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[Press Release] New VaxArray Potency Test Kit for Pandemic Flu Vaccines

[Press Release] InDevR launches a new product that could shave weeks off the timeline to deliver flu vaccines in the event of a pandemic.

InDevR has announced that it has expanded its VaxArray® product portfolio with a new reagent kit to address the “need for speed” in combating flu viruses with pandemic potential. The VaxArray Influenza Pandemic Hemagglutinin potency test kit is now available for flu vaccines containing H5, H7, and H9 flu subtypes, which includes new H7 vaccines against the deadly avian H7N9 virus. This new potency assay enables rapid determination of immunogenic hemagglutinin in
low-dose and adjuvanted flu vaccines.

The panel of monoclonal antibodies that provide the test with virus subtype specificity were developed by scientists at the Center for Biologics Evaluation and Research (CBER) within the US Food and Drug Administration (FDA) and licensed by InDevR in 2017.

Avian influenza viruses, especially A/H5N1 and A/H7N9 viruses represent the latest threat for a lethal influenza pandemic. According to the December 2017 Risk Assessment Summary by the World Health Organization (WHO), “Since 2013, a total of 1565 laboratory-confirmed cases of human infection with avian influenza A(H7N9) viruses, including at least 612 deaths, have been reported to WHO.” In response to concerns over these deadly H7N9 flu viruses, in 2017 the US government issued a call for new vaccines to include in the Strategic National Stockpile for protection of the US population in the event of an outbreak.

To enable a rapid vaccine response during a severe outbreak or pandemic, there is a pressing need for a potency test that is rapid and has sufficient sensitivity to track potency in dosesparing and adjuvanted vaccines. The current gold standard method for flu vaccine potency determination, single radial immunodiffusion (SRID), falls short on all these counts. Most importantly, it can take months to develop the reference reagents needed to perform the SRID assay, which, as demonstrated in the 2009 H1N1 pandemic can delay the delivery of flu vaccine.

In contrast, the VaxArray® Pandemic Hemagglutinin Potency product is ready for use “off the shelf” and, subject to regulatory approval for lot release testing, could be implemented immediately for dose-sparing and/or adjuvanted vaccines if a new, responsive H5, H7, or H9 flu virus emerges as a threat.

The new test kit complements InDevR’s VaxArray® Seasonal Hemagglutinin potency assay and InDevR’s potency testing service, which includes a potency assay for neuraminidase. More product information is available at: https://indevr.com/products/vaxarray/.

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

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InDevR licenses Mount Sinai influenza antibodies

InDevR licenses Mount Sinai influenza antibodies for VaxArray neuraminidase potency assay

VaxArray technology advances toward tracking neuraminidase levels in flu vaccines through an exclusive, worldwide antibody license agreement with the Icahn School of Medicine at Mount Sinai.

InDevR, a Boulder-based progressive analytical technology and life science instrumentation company today announced that it has entered into an exclusive, world-wide license agreement for monoclonal antibodies developed by scientists at the Icahn School of Medicine at Mount Sinai. The license agreement with Mount Sinai will provide InDevR with a unique set of anti-neuraminidase monoclonal antibodies for rapid, subtype specific quantification of neuraminidase in the multiplexed VaxArray system.

As the maker of the VaxArray Vaccine Potency platform, InDevR is focused on providing vaccine manufacturers with streamlined and cost efficient tools to modernize vaccine production. The commercially available VaxArray Influenza Seasonal Hemagglutinin Kit for seasonal influenza vaccine potency is used for quantification of hemagglutinin within influenza vaccines. InDevR also has a strong product development pipeline that includes VaxArray reagent kits for pandemic hemagglutinin and flu neuraminidase.


According to Dr. Kathy Rowlen, InDevR’s CEO, “There is growing scientific evidence that neuraminidase plays an important role in the immune response to flu vaccines. However, the levels of neuraminidase in flu vaccines are not currently regulated, in part because there are no commercially available reagent kits for quantification. Our goal is to create a reliable ready-to-use assay that will ultimately enable the flu vaccine industry as a whole to better understand how neuraminidase levels impact flu vaccine efficacy. This license for the superb antibodies developed at Mount Sinai will help us achieve that goal.”


“We’re thrilled to enter into a partnership with InDevR to advance this Mount Sinai technology into the flu vaccine ecosystem. This invention reflects the efforts of talented scientists here at Mount Sinai who combine their expertise in life sciences with their drive for innovation and translation of commercially-relevant research,” said Erik Lium, PhD, Senior Vice President of Mount Sinai Innovation Partners.

About InDevR

InDevR has a demonstrated commitment to innovative solutions for the life science industry. With focus on enhancing 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. In addition to the VaxArray® Vaccine Potency system, InDevR also developed and markets Cypher One™ Automated Hemagglutination Analyzer for use in hemagglutination and hemagglutination inhibition assays. For more information about the company and products, please visit https://www.indevr.com or call 303-402-9100.

About Mount Sinai Innovation Partner (MSIP)

MSIP is responsible for driving the real-world application and commercialization of Mount Sinai discoveries and inventions, and the development of research partnerships with industry. Our aim is to translate discoveries and inventions into healthcare products and services that benefit patients and society. MSIP is accountable for the full spectrum of commercialization activities required to bring Mount Sinai inventions to life. These activities include evaluating, patenting, marketing and licensing new technologies building research, collaborations and partnerships with commercial and non-profit entities, material transfer and confidentiality, coaching innovators to advance commercially-relevant translational discoveries, and actively fostering an ecosystem of entrepreneurship within the Mount Sinai research and health system communities. For more information, visit http://www.ip.mountsinai.org.

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InDevR Receives NIH Support for VaxArray® Pandemic

InDevR Receives NIH Support for VaxArray® Pandemic Influenza Vaccine Potency Test

New VaxArray® potency reagent kit for potential pandemic H7N9 vaccines

InDevR, Inc., an innovative life science company dedicated to improving biopharmaceutical and vaccine manufacturing, announced support from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), for verification and validation studies on a new potency test for influenza viruses with pandemic potential. The resulting VaxArray® Pandemic Hemagglutinin Potency test will complement InDevR’s VaxArray® Seasonal Hemagglutinin Potency test kit, which is commercially available. This project was supported as part of the inter-agency Influenza Vaccine Improvement Initiative through the Department of Health and Human Services.

The so-called 5th wave of avian influenza A/H7N9 viruses represents the latest threat of a lethal influenza pandemic. According to the World Health Organization, “As of 16 May 2017, a total of 1486 laboratory-confirmed cases of human infection with avian influenza A(H7N9) viruses, including at least 571 deaths, have been reported to WHO… The number of human infections with avian influenza A(H7N9) viruses and the geographical distribution of human cases in the fifth epidemic wave (i.e. onset since 1 October 2016) is greater than any earlier wave.”

There is an urgent unmet need for a potency test that is rapid, has sufficient sensitivity to track potency in dose-sparing vaccines, and is capable of working in the presence of adjuvants. The current gold standard method for flu vaccine potency determination, single radial immunodiffusion (SRID), is not sufficiently sensitive and not compatible with common adjuvants that are known to enhance vaccine performance. Most importantly, it can take months to develop the reference reagents needed to perform the test, which, as demonstrated in the 2009 H1N1 pandemic can delay the delivery of flu vaccine. In contrast, the VaxArray vaccine potency testing platform developed under NIH Small Business Innovation Research (SBIR) grant R44AI102318 meets all of these requirements and does not rely exclusively on traditional reference reagents.

“These supplemental funds from NIAID will enable InDevR to complete all verification and validation activities for our VaxArray pandemic influenza potency test, which has been demonstrated to work with recent H7 and H5 influenza viruses. We anticipate the new reagent kit being available to vaccine producers before the Northern Hemisphere flu season is in full swing this year and we encourage interested parties to contact us for early access,” said Kathy Rowlen, Chief Executive Officer of InDevR.

For more information email InDevR at info@indevr.com or visit the VaxArray® product page.

About InDevR:

InDevR is committed to developing 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. Click Here for more information about the company and products, or call +1 303-402-9100.

This project is supported by NIAID, NIH under Award Number R44AI102318. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

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InDevR Cypher One™ Collaborative Study With FDA Published

InDevR Cypher One™ Collaborative Study With FDA Published

InDevR, FDA Study, “Automated interpretation of influenza hemagglutination inhibition (HAI) assays” published in PLOS ONE

InDevR, Inc., an innovative life science company dedicated to improving biopharmaceutical and vaccine manufacturing, announced study results and a joint publication with the U.S. Food and Drug Administration (FDA) of “Automated interpretation of influenza hemagglutination inhibition (HAI) assays: is plate tilting necessary?” in the scientific journal PLOS ONE.

Serological screening is an important step in influenza monitoring and vaccine development. The hemagglutination inhibition assay (HAI) is widely used to evaluate vaccine-induced antibody responses as well as to antigenically characterize influenza viruses. HAI results are based on an endpoint titration where the titers are typically manually interpreted and recorded by a trained expert. For serological applications, the lack of a standardized endpoint interpretation and presence of interfering non-specific inhibitors can translate into a high degree of variability in the results. This variability along with the lack of a digital record limits is a recognized weakness of the assay.

In the study, a side-by-side comparison of titer calls for more than 2,200 serum samples was made by the Cypher One automated hemagglutination analyzer without tilting and by an expert human reader with tilting. The HAI analysis was performed by FDA as part of its biannual human serological testing of influenza viruses.

Despite prevalent non-specific inhibition, high overall agreement (95%) and good correlation were observed between the results from an expert human reader and the Cypher One system. Even in the presence of challenging samples where the endpoint was non-existent or not obvious, the Cypher One system did not require tilting for accurate interpretation.

The Cypher One Hemagglutination Analyzer is a commercially available instrument for rapid automated analysis, standardization and digital record creation for the interpretation of HA and HAI assays. The Cypher One analyzer reduces subjectivity and enhances data integrity.

“This study supports the impact that Cypher One can have on standardization and interpretation of HAI assays where historically plate tilting was needed to make an accurate titer call,” said Erica Dawson, Chief Technology Officer of InDevR. “At 95.6% agreement, Cypher One offers the scientist a tool to reduce manual call subjectivity and provides an auditable record to meet current data integrity needs of the industry.”

Development of the Cypher One product was supported in part by Phase 1 and 2 Small Business Innovation Research (SBIR) grants from the National Institutes of Health, National Institute of Allergy and Infectious Diseases (NIAID).

Cypher One Analyzer is commercially available. More information is available at: https://indevr.com/products/cypher-one/

About the Study:

Wilson G, Ye Z, Xie H, Vahl S, Dawson E, et al. (2017) Automated interpretation of influenza hemagglutination inhibition (HAI) assays: Is plate tilting necessary?. PLOS ONE 12(6): e0179939. https://doi.org/10.1371/journal.pone.0179939

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 PLOS ONE:

PLOS ONE is the world’s first multidisciplinary open access journal, accepting scientifically rigorous original research across a variety of scientific and medical disciplines. PLOS ONE is published by the non-profit Public Library of Science, created to serve the interest of scientists and the public good.

As PLOS ONE is an open access journal, copies of the publication are freely available for viewing and download.

FDA 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 FDA.

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