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First influenza-specific neuraminidase test kit for flu vaccines

作者:InDevR, Inc.

时间 :2018/6/12 0:00:00

BOULDER COLORADO (6/12/18) -- InDevR Inc. announced product release of the first ever commercial reagent kit designed explicitly for assessment of neuraminidase (NA) in influenza vaccines. The new VaxArray kit is poised to help improve influenza vaccines by empowering manufacturers with a standardized method to meet current regulatory requirements and to prepare for future trends. The VaxArray NA kit is also expected to serve as an important new tool in the push for a more broadly protective or "universal" flu vaccine.

The level of neuraminidase (NA) in flu vaccines is not currently regulated but its "presence and type must be confirmed by suitable enzymatic or immunological methods" during vaccine manufacturing. Since no standardized method exits, vaccine producers each implement their own approach and many use non-influenza specific enzymatic activity assays. The VaxArray Influenza Seasonal NA kit is based on N1, N2, and B-NA subtype-specific monoclonal antibodies arrayed for use in a simple, multiplexed immunoassay. The assay is quantitative, highly correlated with enzymatic activity, stability indicating, and has been demonstrated to serve as a proxy for immunogenicity (see Vaccine 36 (2018) 2937-2945).

The VaxArray system has been evaluated by academic leaders who are working toward the ultimate goal of a universal flu vaccine. For example, Prof. Florian Krammer from the Department of Microbiology at the Icahn School of Medicine at Mount Sinai commented: "The VaxArray system is fast and easy to use. Since it is based on an immunoassay, the results are similar to ELISA in terms of specificity and sensitivity. However, the multiplexed microarray format provides substantially more information and higher throughput than ELISA-based assays. We believe that this system will be a valuable asset in helping us investigate the impact of NA in flu vaccines, including new universal flu vaccines."

This view was echoed by Dr. Francesco Berlanda Scorza, PATH, Director of Vaccine Development: "PATH is working toward sustainable production of high-quality, affordable seasonal and pandemic influenza vaccines in developing countries with a focus on new low cost vaccines for children, including innovative broadly protective influenza vaccines. Improving our understanding the role of neuraminidase is an important component of this effort and we welcome advances to specifically measure neuraminidase content in new vaccine candidates. The new VaxArray NA reagent kit has the potential to greatly accelerate this effort."

Vaccine industry leaders also see a need for better ways to assess the NA content in more traditional flu vaccines. According to Dr. Manon Cox, CEO of Next Wave Bio who led the development of the first recombinant influenza vaccine (Flublok®):

"As articulated by the focus group NAction! in a well-crafted position paper there many outstanding questions about the role neuraminidase in flu vaccines. For example, the level and quality of NA in vaccines can vary dramatically. Thus, one critical sticking point has been the lack of understanding the levels and stability of NA in flu vaccines as no standardized methods for the detection of NA exist. InDevR's VaxArray assay for NA represents a major breakthrough that will enable unprecedented characterization of NA in both monovalent and multivalent vaccines."

The VaxArray platform is expected to impact animal influenza vaccines as well. As described by Dr. Ben Hause, Vice President for Research and Development at Cambridge Technologies: "Advancements in flu vaccines for animals can happen quickly and we understand that neuraminidase could play an important role in enhancing flu vaccine effectiveness. This new potency assay for NA comes at just the right time and provides a much needed standardized method."

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Development of the VaxArray vaccine potency testing platform was supported in part by the Department of Health and Human Services' (HHS) Influenza Vaccine Improvement Initiative through a Small Business Innovation Research grant R44AI102318 from the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health. HHS also sponsored a now-published study that demonstrated a predictive relationship between VaxArray-determined NA levels and vaccine-induced immunogenicity in mice through the Vaccine Manufacturing and Characterization Preclinical Services contract (HHSN272201200005I).

The first VaxArray Influenza Seasonal NA reagent kits are slated to ship on July 1st, 2018 and InDevR is now accepting advance purchase orders. InDevR also offers vaccine potency testing services. Find more information about the entire VaxArray product line at: https://indevr.com/products/vaxarray/

About InDevR

InDevR has a demonstrated commitment to innovative solutions for the life science industry. With focus on enhancing diagnostics, 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 http://www.indevr.com or call 303-402-9100. The content of this announcement is solely the responsibility of the authors and does not necessarily represent the official views of HHS or its institutions.

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技术支持:北京华宇星航国际教育科技有限公司 豫ICP备17016808号

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