Letter from Colorado Governor-elect Jared Polis
InDevR’s VaxArray Platform to Tackle Measles-Rubella Vaccines
VaxArray to improve potency testing for MR vaccines with support from Bill & Melinda Gates Foundation
BOULDER (11/8/18) — InDevR announced today that it will pursue proof of concept development for new VaxArray potency assays for measles (M) and rubella vaccines sponsored by the Bill & Melinda Gates Foundation. The long-term objective is to create in vitro measles and rubella potency assays in order to deliver high quality MR vaccines to market faster and with lower production costs. The project will leverage the multiplexed VaxArray platform, which was first developed and validated for more efficient potency testing of influenza vaccines.
Accurate measurement of vaccine “potency” is critical because it allows vaccine producers to package just the right amount of the active ingredient. Under-filling can result in a sub-potent vaccine that does not protect the patient and over-filling can cause a safety issue – both cases result in unacceptable product.
Measles and rubella (“German Measles”) are highly contagious diseases that have significant health impact around the world. According to the Measles and Rubella Initiative (https://measlesrubellainitiative.org/learn/the-problem/), before the year 2000 over a half million children died each year from measles and associated complications. This disease can be prevented by well-proven vaccines. In order to deliver the vaccine to all those in need around the globe, it would be beneficial to streamline the vaccine manufacturing process.
Dr. Klaus Stohr, former Head Global Public Policy at Novartis Vaccines, commented “There is no doubt that measles and rubella vaccines will remain cornerstones of pediatric immunization programs in both developed and developing countries. VaxArray has the potential to reduce production cost and could become an important addition to increasing the availability of these life-saving vaccines worldwide.”
Currently, time-consuming biological tests such as tissue culture infectious dose (TCID50), which takes 1-2 weeks to complete, are used to measure potency for MR vaccines. The VaxArray platform offers 2-hour assays for tracking potency throughout the vaccine manufacturing process, which could reduce production time by weeks and possibly shave months off of the time required to deliver vaccine to market. For example, measles and rubella TCID50 specifications for vaccine release are currently 3000 and 1000 infectious particles/dose, respectively. A more accurate potency assay for each of these live attenuated virus antigens would minimize risks and reduce expensive lot rejections.
InDevR’s CEO, Kathy Rowlen, Ph.D., said “We are thrilled to partner with the Bill & Melinda Gates Foundation. Their sponsorship of this project is further validation of the potential of our VaxArray platform for enhancing vaccine potency testing.”
Find more information about the complete VaxArray product line at: https://indevr.com/products/vaxarray/
Initial product development of the VaxArray platform was sponsored as part of the Department of Health and Human Services’ inter-agency Influenza Vaccine Improvement Initiative. Specifically, product development for influenza vaccines 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).
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 100th 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 “5th 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.
First Influenza-Specific Neuraminidase Test Kit
InDevR’s game-changing VaxArray® vaccine potency testing platform now includes a reagent kit for rapid assessment of neuraminidase in influenza vaccines
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 exists, 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.”
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/
InDevR publishes high impact article in Vaccine: VaxArray for hemagglutinin and neuraminidase potency testing of inﬂuenza vaccines