BOULDER, Colo., May 10, 2022for rapid and accurate assessment of pneumococcal vaccines at all stages of manufacturing, including multivalent drug product. This launch is accompanied by the availability of a new and improved VaxArray software package that offers greater flexibility in experimental setup and data analysis.
InDevR's powerful new pneumococcal assay, capable of simultaneous quantification of 23 high-priority serotypes in a single test, was developed with funding from the Bill & Melinda Gates Foundation using InDevR's established VaxArray Platform. Included in the kit are numerous monoclonal capture antibodies specifically developed by PATH and partners to improve standardization for future vaccine development and subsequently made available to the industry through a repository housed at the Medicines and Healthcare products Regulatory Agency site in South Mimms, UK, where NIBSC standards and research are developed. With this assay's time to result of less than 30 minutes, the test offers substantial time, throughput, and labor savings over the singleplex technologies currently utilized in pneumococcal vaccine characterization. "We are thrilled to see these high-quality antibodies enable the development of critical technologies supporting characterization and manufacture of more effective and affordable pneumococcal vaccines," states David Boyle, Laboratory Director, PATH Diagnostics program.
At the heart of the VaxArray Pneumococcal Assay is a microarray consisting of 23 monoclonal antibodies specific for high-priority serotypes in both on-market and in-development pneumococcal vaccines. The assay can be utilized to characterize both pneumococcal conjugate and pneumococcal polysaccharide samples from throughout development and manufacturing, including analysis of highly multivalent Drug Products. In addition, a number of detection labeling strategies are available - an optimized 23-valent polysaccharide labeling mixture for use with both monovalent and multivalent samples offers convenience, and individual detection labels can also be combined into a variety of custom mixtures as needed.
The VaxArray Pneumococcal Assay represents an exciting new tool for pneumococcal vaccine characterization, enabling global vaccine manufacturers to multiplex the quantification of numerous vaccine-relevant serotypes in a single test. Unlike many commonly utilized singleplex assays, the inherent multiplexing capabilities of the VaxArray Platform mean the Pneumococcal Assay can be utilized consistently to analyze polysaccharide content throughout manufacturing, release, and stability testing, and eliminate the requirement to bridge different analytics between drug substance and drug product.
Erica Dawson, CTO of InDevR, noted, "Our VaxArray Pneumococcal Kit represents a considerable leap forward in the ability to consistently and accurately identify, quantify, and assess stability for up to 23 high-priority serotypes in a single assay using an off-the-shelf kit. We are grateful to our PATH colleagues, as the assay is strengthened by inclusion of a variety of their high-performing, serotype-specific antibodies. Given the importance of pneumococcal conjugate vaccines in childhood vaccination schedules worldwide, we hope this assay can streamline analytical characterization of these critical vaccines for manufacturers around the globe, particularly to empower manufacturers in lower- and middle-income countries where significant efforts are underway to introduce new pneumococcal vaccines to the market."
As InDevR's first product offering for the bacterial vaccines market, the VaxArray Pneumococcal kit and updated software are high-impact additions to a growing portfolio of existing VaxArray products and services, consisting of a suite of off-the-shelf and custom antigen and serological kits for influenza, coronavirus, measles & rubella, and polio, as well as testing services.
Media Contact:
Terry Salyer, CCO
Phone: 650-520-8251
Email: salyer@indevr.com
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