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PATfix™ pDNA analytical platform for rapid monitoring and optimization of pDNA production process

BPI eBook: Commercialization of Cell & Gene Therapies

Nejc Pavlin, Blaž Bakalar, Špela Kralj, Janja Skok , Andreja Gramc Livk, Aleš Štrancar

Abstract:

Plasmid DNA (pDNA) has become a crucial component in the production of next generation therapeutics such as messenger RNA (mRNA) and viral vectors. As companies ramp up their production capabilities and move towards clinical applications, obtaining cGMP grade pDNA has become a production bottleneck, leading to lengthy production delays. There is a growing market demand for solutions that can streamline the production of cGMP pDNA and help optimize down-stream processes (DSP) for better yields & purity. The key step in this process is having quantifiably reliable analytics that give rapid results for process optimization and scale-up, as well as production runs. Establishing and expanding in-house pDNA production platform in a quick and efficient manner will be a key differentiator between more and less successful next generation therapeutics projects.

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