New rapid sterility test brings lightning-fast results for testing short shelf-life drugs

Effective sterility testing is a crucial component in the manufacturing of life-saving drugs and therapies, ensuring that patients are not exposed to harmful pathogens during treatment. Despite this, current compendial sterility testing methods have a lengthy turnaround time of 14 days, making them drastically insufficient for many drugs with short shelf-lives, especially the increasing number of novel cell therapies that are fully incompatible with membrane filtration methods.

With this strong demand for faster sterility testing solutions, Alpha Laboratories is excited to introduce the new RiboNAT™ Rapid Sterility Test by FUJIFILM Wako Lab Chemicals. RiboNAT cuts sterility test time down to just 7 hours, delivering sensitive and accurate results without the long wait typical of standard testing methods.

RiboNAT uses the Nucleic Acid Amplification (NAT) method to target ribosomal RNA (rRNA) and amplify using RT-rPCR. The use of ribosomal RNA instead of genomic DNA offers substantial benefits over traditional NAT testing – rRNA is present in higher relative quantities within microorganisms, maximising sensitivity and detecting a wide range of bacteria and fungi.

rtPCR following DNA isolation with a typical DNA extraction kit is highly prone to false positives, which can significantly impact the manufacturing process by excessively flagging residual DNA and DNA from dead microorganisms. RiboNAT largely avoids this problem by using nucleic acid inactivator and DNase to degrade residual DNA, ensuring only real contaminants are detected.

This new rapid sterility test will allow short shelf-life cell therapies to be safely and rapidly delivered to the market, where many treatments are currently administered to patients at risk as compendial sterility testing cannot be conducted in a reasonable timespan. RiboNAT has a simple and easy-to-learn testing process, seamlessly adding a crucial control point for sterility quality control into your workflow. Unlock rapid sterility testing and improve patient safety with RiboNAT today!

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