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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.

Residual DNA tests

Residual DNA tests Residual DNA tests

Much like typical chemical compounds, nucleic acid gene therapy agens, such as plasmids/vectors, viral particles and other, need quality control as well. Mostly it is a detection of unwanted contaminants what is needed. These contaminants originate from production systems where DNA was prepared, either from a cultivation media or as natural contaminants or from the changed original molecule.

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