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.
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 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.
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.
While the CGTG-102 oncolytic adenovirus has shown efficacy as a single agent against several soft tissue sarcomas, it would also be appealing to use in combination with other regimes, as oncolytic viruses have demonstrated very little overlap in side effects with traditional therapies such as chemotherapy and radiation.
Mycobacterium tuberculosis is an obligate aerobic acid resistant rod-shaped bacterium which causes most of the cases of tuberculosis. The term Mycobacterium tuberculosis complex includes closely related bacteria causing the same clinical symptoms – M. tuberculosis, M. bovis, M. africanum, M. microti and M. canetti.
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