GMP & GLP TESTING

We are a GLP and GMP certified EU-located company providing testing specialized in molecular genetic based methods (NAT – nucleic acid tests). Our typical partners are general CROs outsourcing their DNA/RNA-based tests elsewhere. For (pre)clinical trials, we offer tailored analytical methods according to CROs´ demands. We also provide QC for batch release for pharma products as well (GMP testing).

Regarding biological drugs such as gene therapy compounds, biomolecules, vaccines, etc., GENERI BIOTECH covers all stages of development of a new drug – beginning with drug discovery via GLP preclinical testing phase up to later clinical tests.

When the development is successfully concluded, we provide DNA/RNA-based testing for the manufactured pharmaceutical cGMP.

Organism identification

Organism identification Organism identification

If organism identification is needed the analysis of DNA fingerprints is method of choice. For identification so called DNA barcoding method can be used. This method uses a DNA analysis of specific sequences to identify an unknown sample in terms and classify it to particular species.

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Endotoxin detection

Endotoxin detection Endotoxin detection

This test reveals contamination by bacterial endotoxins (lipolysaccharide), which is a membrane component of gram-negative bacteria. This reaction is the basis of LAL test, used for detection and quantification of bacterial endotoxins.

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Adenovirus detection

Adenovirus detection Adenovirus detection

Adenoviral vectors serve as oncolytic viruses in many applications and our laboratory has experiences with detection method development, validation and sample analysis. Good example for adenoviral vectors is CGTG-102 (or ONCOS-102), which is in clinical phase now.

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DNA/RNA integrity

DNA/RNA integrity DNA/RNA integrity

Integrity of DNA/RNA is very important test needed according to the Europe pharmacopeia chapter 5.14. Mostly the test can be done as agarose gel electrophoresis or using advanced techniques such as PCR or fragment analysis.

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Mycobacterium tuberculosis

Mycobacterium tuberculosis Mycobacterium tuberculosis

Mycobacterium tuberculosis is an obligate aerobic acid resistant rod-shaped bacterium which causes most of the cases of tuberculosis. The term Mycobacterium tuberculosis complex includes closely related bacteria causing the same clinical symptoms – M. tuberculosis, M. bovis, M. africanum, M. microti and M. canetti.

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