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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.

Nucleic acid DNA/RNA – Biodistribution studies

Nucleic acid DNA/RNA – Biodistribution studies Nucleic acid DNA/RNA – Biodistribution studies

Cell and gene therapy are new branches of pharmaceutical research, which use new types of drugs and strategies. New types of analytical methods are obviously needed. These methods are mostly based on DNA or RNA analysis, which is not surprising, as nucleic acid such as viral vectors, naked DNA (like plasmid, oligonucleotide) or RNA, as active agens is typically used for methods of gene therapy.

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Authentication of cell lines

Authentication of cell lines Authentication of cell lines

Authentication of human cell lines is based on DNA finger print analysis, which compares so-called "short tandem repeats" (STR), segments of genomic DNA of the tested cell line, with identical segments of a cell line with a confirmed identity. STR profiles for many of cell lines are published in reviewed databases.

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