Categories

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.

Assay development, validation and transfer Assay development, validation and transfer
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Organism identification Organism identification Organism identification
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Endotoxin detection Endotoxin detection Endotoxin detection
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Adenovirus detection Adenovirus detection Adenovirus detection
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DNA/RNA integrity DNA/RNA integrity DNA/RNA integrity
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Mycobacterium tuberculosis Mycobacterium tuberculosis Mycobacterium tuberculosis
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