Nucleic Acid-Based Sterility Testing

Sterility Testing

Nucleic acid-based sterility testing (NAT-based testing) is a novel technology based on realtime PCR (QPCR) used for the investigation of time, sensitivity and quantity-critical applications (sterility testing using nucleic acid technology). The technology belongs to the so-called rapid microbiological methods and can be used especially where the culture-based sterility test according to EP 2.6.1 or 2.6.27 are too slow or cannot be used due to certain product properties.

The kits Microsart® ATMP Bacteria and Fungi (Sartorius Biotech GmbH) kits utilized in our laboratory are a new development that, in combination with particle-based DNA extraction, make NAT-based sterility testing possible (internal service name: SteriEP). With the help of this QPCR-based service, we can perform sterility tests on suitable matrices within 24-48 hours (or in the express mode in about 8 hours).

In our laboratory, we already have several years of experience with the 1st generation systems like the conventional bacterial rapid test Onar® Bacteria (Minerva Biolabs GmbH). Furthermore, we regularly carry out tests for mycoplasmas and viruses in compliance with EP 2.6.21 (guideline for NAT-testing) on various biopharmaceutical materials (cell culture supernatants, cell cultures, sera, biologics).

We are currently carrying out the first customer-specific matrix validations using the manufacturer-validated systems. You are welcome to contact us if you are interested in our introductory offers and would like to use and make this technology a joint success.