UpTempo(SM) Plasmid Platform Seamless Transitions from Bench to CGT Applications
Summary: Plasmid DNA is a vital component in the production of viral and nonviral cell and gene therapies (CGT). Catalent’s innovative UpTempo℠ Plasmid Platform Process has revolutionized plasmid DNA manufacturing by addressing key challenges and significantly reducing development time. This streamlined process accelerates the transition from pre-IND phases to clinical trials, bringing life-changing therapies to patients faster. Designed to handle a diverse array of plasmid sequences, the UpTempo℠ Platform boasts impressive yields, producing up to 0.5 grams of purified plasmid DNA per liter of fermentation culture. The fully disposable manufacturing process not only speeds up turnaround times but also minimizes the risk of cross-contamination. Catalent’s rigorous analytical platform and specifications ensure plasmid purity profiles meet program requirements and adhere to cGMP regulatory standards.