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.
NorthX Biologics is a CDMO and Innovation Hub in Advanced Biologics, with +30 years of GMP production experience. The team provides process development and GMP manufacturing services with expertise in plasmid DNA, mRNA, proteins, cells and other advanced biologics. Headquartered in the heart of Sweden, the team serves customers worldwide and in 2021 was recognized as a national innovation hub for advanced therapeutics and vaccines. NorthX Biologics has the ambition to become a leading cell and gene therapy manufacturer and partner of choice for innovative drug development companies.
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