Plasmid DNA – The right quality for each application

With the tremendous advances in cell and gene therapies, and the unprecedented success of vaccines based on nucleic acid seen during the Covid pandemic, the need for high quality plasmid DNA have increased dramatically. For cell and gene therapy irrespective if the therapy is an ex-vivo gene therapy like CAR-T cells, or an in-vivo direct gene therapy mediated by viral vectors, the plasmids are transfected into cells to generate the protein that possess the immunogenic or therapeutic effect.

Depending on the application, the plasmid DNA is considered a critical starting material or a drug substance with the accompanied differences in regulatory and quality expectations. Considering the importance of the plasmid DNA in providing the blueprint for the therapeutic protein, the need for a well-designed, phase appropriate control and testing
strategy cannot be underestimated.