UpTempo℠ Plasmid DNA Platform: Single-Use Innovation For The Future Of Therapeutic Manufacturing

By Vicky Argyropoulou, Julien Glibert, Sebastien Gillet, Chris Kistler, Huacheng Wu, Matthias Craig, Nuria Gomez Santos

Plasmid DNA (pDNA) serves as a vital starting material in the production of both viral and non-viral cell and gene therapies (CGT). As a cornerstone of these transformative treatments, the efficient and reliable manufacturing of pDNA is essential to ensure the success of CGT programs. Catalent has addressed the challenges inherent in pDNA manufacturing by developing innovative, robust processes and analytical platforms designed to deliver top-quality plasmid DNA while significantly reducing development time.

Catalent's approach is centered around a versatile and high-yielding, one-process-fits-all single-use (SU) manufacturing platform that adheres to the rigorous standards of current Good Manufacturing Practices (cGMP). This streamlined methodology enhances efficiency, minimizes contamination risks, and provides flexibility across various pDNA quality grades and therapeutic applications.

The integration of Catalent’s pDNA manufacturing platform with its viral vector services offers a seamless and efficient end-to-end service to CGT developers. This comprehensive solution supports customers at every stage of their program, from early-stage lead identification and development to clinical trials and eventual commercial-scale production. By combining technical expertise, regulatory compliance, and cutting-edge technology, Catalent ensures that clients have the resources needed to successfully advance their CGT programs from concept to patients.