MilliporeSigma's Arana Maps the Gaps Holding Back CGT Manufacturing

Cell and gene therapy manufacturing is roughly where monoclonal antibody production stood a quarter-century ago, according to Sebastián Arana, global head of Process Solutions at MilliporeSigma, the life science business of Merck KGaA, and that comparison says a lot about how much ground is left to cover.

In the second installment of his conversation with our sister publication BioPharm International, Arana, turns to the unresolved manufacturing problems in CGT, the biggest themes coming out of the 2026 BIO International Convention (BIO 2026, June 22–25 in San Diego), and why collaboration across the supply chain is becoming non-negotiable.

Check out Part 1 of the interview, in which Arana discusses why modular, digital, platform-based manufacturing, not raw capacity, will define biomanufacturing's next decade.

CGT manufacturing, Arana says, still leans heavily on manual, customized processes. Getting to reproducible, scalable production will take real advances in automation, process optimization, advanced analytics, and real-time monitoring, but the field isn't there yet.

Asked where the biggest unresolved problems sit in CGT scale-up, Arana points to three:

1. Process characterization gaps remain one of the most consistent issues developers run into.
2. Technology transfer has grown more delicate as biological systems get involved, especially when a therapy made at one site has to be reliably reproduced at another.
3. Analytical readiness keeps lagging behind manufacturing ambitions, a gap Arana argues companies need to close proactively, before scale becomes the immediate problem rather than the long-term goal.

"If you cannot manufacture it, produce it, and scale it up at the end, it's just a good idea," he says.

Supply chain resilience is the other thread running through Arana's comments. Lessons from the pandemic, he says, have made interdependency and coordination across CGT manufacturing networks more important than ever. Zooming out to BIO 2026 more broadly, Arana describes the conference as confirming rather than revealing a familiar tension: the science keeps outpacing the manufacturing infrastructure built to support it. Flexible manufacturing, digital tools, and collaboration spanning large pharma, biotech, suppliers, and CDMOs came up again and again as the priorities the industry keeps circling back to.