Categories

Plasmid tests

Plasmid tests

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)
  • endotoxin
  • mycoplasma by qPCR
Useful links
Recommended products
Kit for isolation of DNA from tissues

Kit for isolation of DNA from tissues Kit for isolation of DNA from tissues

The DNA extraction kit includes DNA purification step and enables achieving highly pure genomic DNA from various types of human or animal tissues and cultured cells, buccal swabs or paraffin-embedded tissue. Moreover, microbial, fungal or yeast DNA can be efficiently isolated as well. High DNA yields, reproducible results and fast working method are guaranteed.

More
Recommended articles
CRO case studies

Yeast Production Strain Cell Line Authentication by RFLP analysis

Yeast Production Strain Cell Line Authentication by RFLP analysis

Background Probiotics are defined as live microorganisms which, when administered in adequate amounts, confer a health benefit on the host. For instance, probiotics can be used in the treatment and prevention of infections and chronic inflammatory disorders of the gastrointestinal tract. Due to their health attributes, probiotics generate considerable interest in the area of functional

More