InDevR, Inc., a life science tools company providing powerful analytical technologies to support the development and production of vaccines and biotherapeutics, announced commercial availability of its VaxArray® Polio D-antigen quantification kit for rapid and accurate assessment of polio vaccines at all stages of manufacturing, including multivalent drug product.

InDevR's new multiplexed polio test kit was developed with funding from the Bill & Melinda Gates Foundation using InDevR's established VaxArray® Platform in combination with anti-D-antigen human monoclonal antibodies licensed from the Lankenau Institute for Medical Research (LIMR).

The VaxArray Polio Assay provides a 10x-20x faster time to result than the traditional D-antigen ELISA and, unlike "in-house" ELISA, is available as a standardized off-the-shelf kit. Importantly, the kit can be used to quantify all three inactivated or attenuated strains of poliovirus present in polio vaccines, offering a savings in both time and labor relative to the singleplex plate-based ELISA approach. The kit also works effectively with crude samples and for various formulations. This new kit expands the existing portfolio of the VaxArray products, consisting of influenza, coronavirus, measles & rubella kits, as well as custom kits.

The critical reagents in the VaxArray Polio Assay are human monoclonal antibodies against type-specific D-antigen that were isolated and characterized at Lankenau Institute for Medical Research (LIMR) in Wynnewood, Pennsylvania, with efforts led by Dr. Scott Dessain. The development of these antibodies was funded by PATH under a cooperative research and development agreement with LIMR. The PATH/LIMR antibodies are being evaluated for potential use as 'universal reagents' for inactivated Sabin polio vaccines, and once established, these antibodies will be available for distribution by the National Institute for Biological Standards and Control (NIBSC) in the U.K. While developed specifically for inactivated polio vaccines, with the appropriate WHO international standards used as calibrants, the PATH/LIMR antibodies are expected to work with live attenuated polio vaccines as well.

Erica Dawson, CTO of InDevR, noted, "The launch of the VaxArray Polio Assay represents a significant improvement in the ability to standardize D-antigen testing for polio vaccines. We hope the kit's availability will enable expedited and multiplexed testing of critical, safer poliovirus vaccines that are being increasingly applied as the world gets nearer to complete polio eradication. We are confident that this new tool can reduce both bioprocess and release testing costs and ultimately drive down cost per dose, particularly for manufacturers in lower and middle-income countries."

Dr. Kutub Mahmood, Scientific Director at PATH recently noted, "InDevR's VaxArray Polio Assay is an excellent off-the-shelf kit for measuring D-antigen content, allowing global polio vaccine manufacturers to save time by multiplexing and obtaining same-day results during bioprocess R&D and quality control, with high accuracy and sensitivity for bulk substance and final vaccine product. This VaxArray Polio D-antigen test represents an excellent alternative to the traditional plate-based ELISA technology."