New Test for Rapid and Low-cost Quality Control for Polio Vaccines

Batavia Biosciences has developed a qPCR method that can specifically detect mutations that can accumulate in poliovirus strains during vaccine production. The test demonstrates a sensitivity level highly comparable to current best practices. The novel test has been accepted for publication in the international, peer-reviewed prestigious Vaccine journal.
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Leiden, March 2024 – Batavia Biosciences, a contract development manufacturing organization, introduces a new low-cost, and fast tool, suitable for quality control of polio vaccines. This transformative advancement, described in the peer-review journal Vaccine, will provide substantial benefits in the final phases of the global poliovirus eradication efforts.    

To ensure the quality of the poliovirus vaccines and mitigate the risk of producing low immunogenicity batches owing to mutation accumulation in the poliovirus strain during production under laboratory conditions, rigorous monitoring is essential. Currently, this analysis is performed by next-generation sequencing (NGS). However, due to the high cost and time-consuming process, there is a need for a more suitable alternative for analyzing the genetic make-up of virus strains in polio vaccines.  

Lizet Opmeer, vaccine development scientist at Batavia Biosciences and author of the study: “Our mission is to drive innovations that improve vaccine production and ensure that vaccines are globally accessible. By introducing this groundbreaking and cost-saving tool, we aim to significantly contribute to the global effort of eradicating polio.”  

Batavia Biosciences developed a rapid alternative test that is low-cost, highly sensitive and can accurately detect mutations in poliovirus vaccines. Specifically, the new tool is a variant (allele)-specific locked nucleic acid-based reverse transcription quantitative real-time PCR (AS LNA qPCR) technology. This new tool offers comparable results to NGS but with a fraction of the cost and time, improving the quality control process of polio vaccines and potentially reducing production expenses.  

The analytic tool can be applied to measure and control the product quality during process development, scale-up, and release of the vaccine. Also, it is likely applicable to other vaccine strains, serotypes, and mutations. 

This advancing research, conducted in collaboration with Genomescan and with the financial support of the Bill & Melinda Gates Foundation, underscores Batavia Biosciences’ commitment to advancing healthcare technology. Through ongoing projects and initiatives, the organization strives to create lasting positive impacts on global health outcomes, ensuring the availability of safe and affordable biopharmaceuticals for all.

More about AS LNA qPCR test  

AS LNA qPCR, which stands for variant-specific locked nucleic acid-based reverse transcription quantitative real-time PCR technology, is a powerful method that can be used to identify different versions of genes, DNA sequences, or single nucleotide polymorphisms (SNPs). This technique involves converting RNA into DNA and subsequently amplifying and quantifying the DNA in real-time using Quantitative Real-Time Polymerase Chain Reaction (qPCR). The detection of SNP variants is achieved by utilizing fluorescent dye-labeled probes containing Locked Nucleic Acid (LNA), a stable form of modified nucleic acids, which specifically targets and detects specific SNPs.  

It’s like a super-accurate genetic detective tool that can help to find different gene versions. In this case this test specifically detects mutations that can accumulate in poliovirus strains during vaccine production. 

About the study 

“High throughput AS LNA qPCR method for the detection of a specific mutation in poliovirus vaccine strains” by Lizet Opmeer, et al. https://doi.org/10.1016/j.vaccine.2024.01.103, as published in Vaccine, by Elsevier

 DOI: 10.1016/j.vaccine.2024.01.103 
 

About Vaccine 

Vaccine is the pre-eminent journal in the field of vaccinology. It is the official journal of The Japanese Society for Vaccinology and is published by Elsevier. 

https://www.sciencedirect.com/journal/vaccine

Copies of this paper are available to credentialed journalists upon request, please contact the Elsevier Newsroom at newsroom@elsevier.com. 

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