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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.

Plasmid tests

Plasmid tests Plasmid tests

Plasmid DNA is currently gaining increasing importance for clinical research applications in gene therapy and genetic vaccination. For direct gene transfer into humans, good manufacturing practice (GMP)-grade plasmid DNA is mandatory.

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Nucleic acid (DNA) sequence control

Nucleic acid (DNA) sequence control Nucleic acid (DNA) sequence control

Correct sequence control - check if the sequence is free of mutant variant (insertion, deletion, changes), checking the sequence of interest is a good idea. Sanger sequencing method is a gold standard.

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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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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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