UpTempo℠ Plasmid DNA Platform
SINGLE-USE INNOVATION FOR THE FUTURE OF THERAPEUTIC MANUFACTURING
Summary: Plasmid DNA is a critical starting material used to manufacture viral and nonviral cell and gene therapies (CGT). Catalent has successfully addressed the challenges associated with plasmid DNA manufacturing by developing robust process and analytical platforms. Catalent’s approach involves a one-process-fits-all single-use (SU) manufacturing process in compliance with current good manufacturing practices (cGMP) standards. Moreover, Catalent provides a comprehensive end-to-end plasmid service that supports programs from the lead identification and development stages, through clinical and up to commercial manufacturing.
Key Learnings:
- Catalent has developed a single-use plasmid DNA platform process that can deliver from hundreds of milligrams up to double-digits grams in a single GMP batch.
- Catalent’s UpTempo℠ plasmid DNA platform is designed to address challenges encountered in critical stages of plasmid DNA manufacturing including fermentation, lysis, and purification.
- Catalent’s off-the-shelf plasmids are a crucial component of its UpTempo℠ plasmid and viral vector platforms, significantly improving and simplifying the development stage of CGT programs.