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qPCR (nucleic acid) based sterility testing – The release test for sterility in medical applications is prescribed in chapters EP 2.6.1 (Sterility) and 2.6.27 (Cell based preparations). Especially with short-lived products such as ATMPs growth-based methods are clearly too slow. In addition, non-cultivable microorganisms can easily be overlooked. We are currently implementing an alternative nucleic acid amplification-based method for fast and safe testing of your samples.

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Test for Virus Contamination

The use of human or animal primary materials carries the risk of virus contamination. We offer you the opportunity to test your samples for various viruses, such as Hepatitis, HIV or SMRV, as part of in-process controls or batch release of biopharmaceutical materials or products. Extend your quality control and access a variety of interlaboratory performance qualified qualitative real-time PCR virus test systems. We have experience in the study of cell cultures, cell culture supernatants, antibody formulations and many other matrices.

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Test for Bacterial Endotoxins

Bacterial endotoxins – most importantly lipopolysaccharides – are high-molecular weigth complexes that cause a pyrogenic reaction on release and contact with the immune system. High endotoxin levels can lead to a whole series of physiological effects such as fever, septic shock and hyperimmune reactions. Particularly sensitive application are e.g. intravenous administration of (bio-)pharmaceuticals in the clinics. To increase safety for patients endotoxin release test are prescribed by pharmacopoeia. We are happy to examine your samples for endotoxins.

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Mycoplasma Contamination Testing

Mycoplasma is able to pass commercial sterilization filters and resistant to certain common antibiotics. They are small, self-replicating and lack many metabolic pathways. Cell cultures of any kind represent an ideal environment for multiplication of these notorious cell culture contaminants. Once introduced via raw materials or through human contact, they often multiply unnoticed, eventually alter e.g. expression patterns of ATMPs or reduce fermenter yields. We do your Mycoplasma contamination testing and eliminate these notorious bacteria in urgent cases.

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Featured News Post

2017, the year of Minerva Analytix GmbH reorganization: New management, expansion of our service portfolio to include endotoxins and, soon, sterility testing. Our team renews itself and experienced laboratory staff was joining us. You are currently watching our new website and we are happy that you are taking the time to familiarize yourself with the changes. In spite of all the changes, renewal for the sake of renewal does not make sense. The well-known and successful will be maintained and …

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