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.

Nucleic acid DNA/RNA – Biodistribution studies Nucleic acid DNA/RNA – Biodistribution studies Nucleic acid DNA/RNA – Biodistribution studies
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Authentication of cell lines Authentication of cell lines Authentication of cell lines
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Plasmid tests Plasmid tests Plasmid tests
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Nucleic acid (DNA) sequence control Nucleic acid (DNA) sequence control Nucleic acid (DNA) sequence control
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DNA genotyping DNA genotyping DNA genotyping
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Cell proliferation test / cytotoxicity test Cell proliferation test / cytotoxicity test Cell proliferation test / cytotoxicity test
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Gene quantification (qPCR) Gene quantification (qPCR) Gene quantification (qPCR)
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Residual DNA tests Residual DNA tests Residual DNA tests
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Mycoplasma detection Mycoplasma detection Mycoplasma detection
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Viral shedding Viral shedding
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Southern blot analysis/ restriction endonuclease mapping (RFLP) Southern blot analysis/ restriction endonuclease mapping (RFLP)
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Nucleic Acid (DNA/RNA) Extraction Nucleic Acid (DNA/RNA) Extraction
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