Testing of plasmids (non-viral vectors) for gene therapy
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. The same holds true if the drug substance contains a genetically modified cell, for example chimeric antigen receptor (CAR) T cells.
In Generi Biotech, we offer testing of the plasmids for residual host cell DNA, which is considered an unacceptable impurity in an intermediate or final gene therapy product.
We can also test your artificial vectors and viral vaccines for the presence of wild type virus, which is also a contaminant and can pose a serious safety threat.
Our typical GMP package also includes:
- DNA concentration by absorbance spectroscopy (DNA purity by OD 260/280)
- identity test by restriction digest
- total plasmid purity check by agarose gel electrophoresis
- plasmid sequence GMP grade ( four- fold coverage)
- mycoplasma by qPCR