Minerva Analytix – GMP Service Lab

Mycoplasma Testing Prime

Minerva Analytix GmbH provides a modern GMP-certified lab in the immediate vicinity of the capital Berlin (find here “How to get to Minerva Analytix GmbH“). In addition to the development and validation of analytical processes in the area of rapid microbiological testing, we also carry out routine routine testing for microbial contaminations. Our goal is to offer innovative, fast and above all safe methods. One of our main focus areas is DNA / RNA analysis and the search for contaminants in biopharmaceutical products (i.e. biologics), raw materials or excipients, respectively. In addition to mycoplasma testing according to EP 2.6.1 (using QPCR), our service portfolio includes the NAT-based sterility testing (alternative method according to EP 2.6.1), as well as analysis for various human-pathogenic viruses.

In addition to our main topic – the search for contaminating microorganisms – microbial “remains” such as bacterial endotoxins become more and more important (see also our blog article “Importance of endotoxins”). As there is a constantly increasing demand  in the pharmaceutical and biotechnology sector, we have been offering endotoxin analysis using the chromogenic, kinetic method since 2017 and recombinant factor C (rFC) since 2018, respectively. The rFC approach according to EP 2.6.32 is a particularly good match in our innovative portfolio: On the one hand, the method protects the endangered population of horseshoe crabs, on the other hand, rFC provides significantly lower batch to batch variance.

Attention: with regard to the current situation, we have introduced company corona (SARS-CoV-2) screening since March (see also our blog article “Corona virus (SARS-CoV) testing”). This analysis (no clinical samples) is aimed at e.g. authorities, hospitals, old people’s homes or companies with a lot of social interactions (here you can find more information on CoV-2 screening).

In order to continue our highly innovative strategy in the microbiological field and at the same time maintain our capacities at high levels we have expanded our robotics further. However, it is important to us that in addition to high-throughput customers, we can also engage with small companies, clinics and start-ups. Our robots can work with small sample numbers efficiently, in this way we will prevent long sample holding times and shorten your waiting times whether you provide small or large sample amounts. Our lead times are around 24-72 hours and for very urgent samples <8 hours (express testing). Our young, committed team will be happy to help you if you have any questions about our capacities or would like to start working with us right away (contact us here).