PATfix HPLC analytical system is all it takes to accelerate your process development and have continuous at-line production monitoring and robust quality control of nucleic acid drug substances. Designing a correct hardware setup for reproducible analytical separation of large biomolecules is not trivial. Complex IVT mixtures are composed of target molecule (mRNA), process-related impurities (nucleotides, capping reagent, DNA template) and product-related impurities (abortive fragments, dsRNA), all with similar biophysical characteristics. These challenges make the PATfix mRNA platform a preferred analytical solution
Global demand for pDNA production is at an all time high, due to increased need from Gene Therapy ramp-up. pDNA, as an enabling product, is critical in production of mRNA, AAV and other therapeutic vectors. Increasing yield and purity in the production of pDNA is a vital step in meeting such demand. Supporting rapid process development and optimization, PATfix pDNA analytical platform is providing reliable in-process control for pDNA process development and production.