UpTempo℠ Plasmid Platform: Seamless Transitions From Bench To Cell And Gene Therapy Applications

Plasmid DNA plays a critical role in the production of both viral and nonviral cell and gene therapies (CGT). Catalent’s UpTempo℠ Plasmid Platform Process offers a groundbreaking solution to the traditional challenges of plasmid DNA manufacturing by significantly reducing development timelines and accelerating the path from pre-IND stages to clinical trials.

Engineered for flexibility, the platform accommodates a wide variety of plasmid sequences and delivers high yields — up to 0.5 grams of purified plasmid DNA per liter of fermentation culture. Utilizing a fully disposable manufacturing process, UpTempo℠ enhances turnaround times while minimizing cross-contamination risks. Complemented by a robust analytical platform, the process ensures plasmid purity and compliance with cGMP regulatory standards.

This streamlined, end-to-end approach provides a one-stop solution for plasmid DNA development and manufacturing, offering clear advantages such as overcoming common production challenges, reducing lead times for AAV and LVV production, and simplifying supply chain logistics through the use of off-the-shelf plasmids.