InDevR plans to launch a Research Use Only version of their FluChip-8G technology to aid in pandemic preparedness. Click Here to learn more.
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
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.
BOULDER, Colo.–InDevR, Inc., an innovative life science company dedicated to improving biopharmaceutical and vaccine manufacturing, is pleased to announce an exclusive sales, marketing and customer support relationship with I&L Biosystems GmbH and its subsidiaries. The distribution agreement includes sales and support for the Cypher One™ and soon to launch VaxArray™ product lines throughout Western Europe.
InDevR manufactures and sells Cypher One™, an automated hemagglutination analyzer used by biopharmaceutical vaccine manufacturers and veterinary diagnostic labs. The Cypher One™ system automates and standardizes HA and HAI analysis and provides a digital, traceable record to enhance data quality and reliability. InDevR is also developing a comprehensive vaccine potency platform called VaxArray™. When fully launched, the VaxArray™ platform will measure both hemagglutinin and neuraminidase content of both seasonal and pandemic influenza. VaxArray™ will enable biopharmaceutical manufacturers the ability to generate consistent potency data throughout upstream and downstream testing and enhance process recovery applications. InDevR’s products support vaccine developers and manufactures by providing faster turnaround times and improved results at an affordable price. More information can be found at: https://indevr.com/products
I&L Biosystems, a European sales and marketing leader, was founded in 1991 and has been growing ever since. With a focus on sales and distribution of high-quality laboratory equipment to customers and researchers in the field of microbiology, cell biology, biotechnology and process control, I&L Biosystems have established themselves as a proven leader. I&L Biosystems is located in Germany and expands its coverage of western European countries through subsidiaries located in the Netherlands, France and UK. I&L Biosystems’ mission complements InDevR’s unique product lines as both are focused on modernizing the field of life science with respect to vaccine development and production.
“I&L Biosystems brings unparalleled knowledge and expertise to our current and future customers. They offer in-country support with a team of native language speakers that really understand the challenges, successes and trends our European customers experience on a day to day basis,” said Dawn Bitz, Chief Commercial Officer of InDevR. “We are excited to reestablish this relationship with a trusted partner.”
“Our long-lasting relationship with InDevR is based on trust, scientific exchange and a fundamental connection. The combination of InDevR’s knowledge and I&L Biosystems’ experience in the European market is grounded in past successes. Now we are proud to introduce InDevR’s newest technologies into Europe with the confidence that InDevR instruments will be an incredible benefit to our customers,” said Dr. Sandra Balkow, Scientific Sales Director of I&L Biosystems GmbH.
InDevR has a demonstrated commitment to innovative solutions for the life science industry. With a focus on enhancing vaccines and other biotherapeutics, InDevR has emerged as a leader in progressive analytical technologies which has enable accelerated development and manufacturing of their life-saving products. For more information about the company and products, please visit www.indevr.com or call 303-402-9100.
About I&L Biosystems
I&L Biosystems GmbH and its subsidiaries offer high-tech Life Science products throughout all of Europe. They not only build long lasting partnerships with established suppliers around the world but also continuously integrate new technologies into their portfolio. They offer both evidence based scientific consulting as well as professional technical services, which allows them to provide their customers with the best possible support from initial contact throughout installation and beyond. For further information please visit http://www.il-group.eu
The Bioprocessing Summit
August 22 – 25, 2011, Boston, MA
InDevR’s CEO Kathy Rowlen was a guest speaker on the Biotech Panel of the Boulder Economic Summit, May 18th, 2011.