Traditional compendial sterility testing, with its 14-day turnaround, no longer meets the realities of modern pharmaceutical development. For many critical, life-saving products—particularly advanced cell and gene therapies—waiting two weeks for sterility confirmation is simply not viable. These therapies demand faster, highly sensitive methods that deliver confidence without compromise.
Alpha Laboratories is proud to introduce RiboNAT™, the new rapid sterility test from FUJIFILM Wako, developed specifically to meet this challenge. Using Nucleic Acid Amplification Technology (NAT), RiboNAT targets ribosomal RNA (rRNA) and applies RT-rPCR to deliver reliable sterility results in as little as seven hours.
By focusing on rRNA—present in far higher quantities than genomic DNA—RiboNAT achieves exceptional sensitivity, detecting microorganisms down to 9 CFU/mL while maintaining broad coverage across bacteria and fungi. The method also minimizes false positives by inactivating and degrading residual DNA and dead microorganisms using nucleic acid inactivators and DNase.
RiboNAT™ enables confident release of short-shelf-life therapies without added risk, while seamlessly integrating into existing quality control workflows through a simple, easy-to-learn process.
Discover a faster future for sterility testing at www.alphalabs.co.uk/rapid-sterility-testing or contact info@alphalabs.co.uk
