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 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.
Nucleic acid (NA) 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.
Gene quantification (qPCR) 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.
Organism identification If organism identification is needed the analysis of DNA fingerprints is method of choice. For identification so called DNA barcoding method can be used. This method uses a DNA analysis of specific sequences to identify an unknown sample in terms and classify it to particular species.
Southern blot analysis is one of the oldest methods that is used to analyze DNA. In this method, DNA is first extracted from the sample and quantified by UV spectrometry. Then...
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