UpTempo℠ AAV Platform Process

As the pipeline of viral vector-based therapies continues to reach later stage studies, a standardized manufacturing process is necessary for chemistry, manufacturing, & control (CMC) requirements from regulatory agencies & to meet the accelerated timelines for first-in-human studies of advanced therapeutics.

Several of the challenges to standardize viral vector manufacturing include bottlenecks in the supply chain, lack of scalability in processes, and variability associated with customer-driven SOPs, analytical testing, and raw materials. Catalent’s UpTempo℠ AAV platform was developed to address these challenges.

The UpTempo℠ AAV platform process is a scalable, cGMP-ready process for viral vector manufacturing that can reduce the current 18-20-month development timeline for drug product in half.