Breaking the Bottleneck: Solving Late-Stage AAV Challenges with Real World Commercial Experience
Adeno‑associated virus, or AAV, continues to be the dominant viral vector in gene therapy, and the global clinical trial landscape reflects that leadership. Today, we’re seeing investors increasingly focus on programs that are de‑risked—programs supported by strong clinical data, defined CMC strategies, and a credible path to commercial viability. But even with that momentum, moving from early development into late‑stage and commercial readiness remains one of the most challenging parts of the journey.
One of the biggest hurdles sponsors face is finding a CDMO with true commercial AAV experience—partners who haven’t just developed AAV processes but have successfully taken them through global regulatory approvals and into the commercial market.
What we’ve learned is that the most reliable way to avoid late‑stage delays is to address critical manufacturing considerations much earlier in development. And that is exactly where Catalent’s UpTempo® AAV platform adds value. UpTempo® was purpose‑built to streamline early and mid‑stage development, accelerate timelines, reduce regulatory burden, and create a much smoother, more predictable transition into late‑stage and commercial manufacturing.
What differentiates UpTempo® from other platform offerings is Catalent’s depth of real‑world commercial AAV experience. We’re not just optimizing processes—we’re translating them into commercially viable, globally approved products. In short, UpTempo® gives early‑stage developers something they don’t often get: speed without compromising quality, and a clear line of sight from early development to commercial success. And that’s exactly what investors—and most importantly, patients—are looking for.
Beyond the platform itself, our commercial gene therapy facility at BWI gives sponsors a meaningful advantage. The site has been inspected and approved by major regulatory agencies worldwide, which gives developers confidence that we can support them all the way through licensure. It also means they can rely on a single, integrated CDMO partner throughout their entire development journey—eliminating the complexity and risk of transitioning between multiple vendors.
That value is strengthened even further by Catalent’s fully integrated offerings, spanning plasmid development and manufacturing through commercial drug product. Whether a sponsor needs regulatory support for IND submission or help navigating supply chain challenges, we’re positioned to support them from end to end.
And finally, our professional case management services offer something truly unique. Sponsors gain 24/7 access to a dedicated case manager who oversees the orchestration of the entire supply chain—from proactive shipment monitoring to real‑time temperature data and GPS‑enabled tracking and documentation. It’s a level of visibility and reassurance that allows our partners to focus on what matters most: progressing their therapy to patients.
