The new 3.1 software version provides users with many enhanced features that build upon the usefulness of the existing platform. Next generation software includes an improved interface with a new startup screen and other features making the system more user friendly. Increased plate flexibility has also been integrated giving the user the ability to toggle between horizontal and vertical sample use orientations as well as additional exported analytical data to enable tracking and trending of quality control metrics. Finally, with data integrity needs on the rise, the entire system enables compliance with 21CFR Part 11 and Annex 11 guidance.
Overall the Cypher One™ system simplifies analysis of HA and HAI assays, provides enhanced data integrity and reduces risk by providing interpretation consistency and standardization to minimize human errors. The Cypher One™ is used by leaders in the field of human and veterinary flu vaccine manufacturing, contract research organizations, academic institutions, veterinary diagnostic labs, and government entities.
The launch of the next generation 3.1 software expands the benefits of the Cypher One™ instrument and provides an opportunity to continue standardization and data record creation of hemagglutination analysis in serology and virology testing,” says Dawn Bitz, Chief Commercial Officer at InDevR. “With this launch, we continue our dedication to improving influenza vaccine manufacturing by developing innovative, analytical tools that provide superior results.”
Hemagglutination assays are widely used in serology and virology, with applications ranging from blood typing to vaccine efficacy. Currently, hemagglutination assays rely on subjective, manual interpretation, which can lead to significant variations in the measurement between technicians and laboratories. There are a number of industrial and government groups calling for improved standardization in vaccine characterization, e.g., Global Health Network’s CONSISE (https://consise.tghn.org/). In response to these initiatives, InDevR developed an optical analyzer with proprietary software to automate and standardize results interpretation.
Development of the Cypher One system was funded in part by a National Institutes of Health 2-year Phase 1 Small Business Innovation Research grant sponsored by the National Institute of Allergy and Infectious Diseases (R43 AI106054).
For more information about the Cypher One system, click here.
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. For more information about the company and products, please visit www.indevr.com or call 303-402-9100.
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.