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.
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.
Food and feed testing services Although food and feed testing does not fall into pharma testing, some QC tests are based on similar techniques and methods as those used in Good Manufacturing Practice.
Oncolytic viruses, which include both naturally occurring wild-type viruses/attenuated viruses and genetically modified viruses, have recently been developed for use in innovative cancer therapies. Genetically modified oncolytic viruses possess the unique ability to replicate conditionally as a unique gene therapy product.
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...
Nucleic acid extraction can be tedious and time-consuming. It is the most crucial method used in molecular biology and is the starting point for many downstream processes and product development including diagnostic kits. DNA and RNA can be isolated from any biological material such as living or conserved tissues, cells, virus particles, or other samples for analytical or preparative purposes.
Analytical methods are fundamental to all aspects of drug development and manufacturing. Accordingly, they require development, validation, and controls just as all other product and process development activities.
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