Biomanufacturing's Next Decade Will Be Won by Adaptability, Not Capacity

As biopharmaceutical pipelines grow more complex and clinical timelines compress, the biomanufacturers that come out ahead over the next decade may not be the ones with the most capacity. They'll be the ones built to adapt.

That's the central argument from part 1 of a two-part interview with Sebastián Arana, global head of Process Solutions at MilliporeSigma, the life science business of Merck KGaA. Arana spoke with our sister publication BioPharm International ahead of the 2026 BIO International Convention (BIO 2026), held June 22–25 in San Diego, laying out where he sees the biggest manufacturing pressure points building as the industry moves toward increasingly targeted, increasingly varied therapies.

"I feel the winners over the next decade or so will be companies that build that adaptability in their manufacturing ecosystem, not [just] manufacturing capacity," he says. For Arana, that adaptability has a specific shape: "modular manufacturing, digital-enabled, and fundamentally platform-based."

Platform flexibility, in his view, has become the single most important operational capability a biomanufacturer can have. Shrinking clinical timelines and increasingly diverse pipelines mean a single production ecosystem now has to flex across modalities and volume requirements, not simply scale up one product at a time. That shift moves automation, digital tools, and real-time monitoring from nice-to-have into must-have territory.

Equipment upgrades alone won't get manufacturers there, though. Arana cautions that facilities designed for an earlier generation of manufacturing tend to hit a wall once new modalities are introduced: facility-flow bottlenecks, tougher segregation and contamination-control demands, and data systems that don't talk to each other. The more processes get layered onto a site, he notes, the more that data flow becomes a make-or-break factor.

People are part of the equation too. Arana treats workforce retraining as a strategic priority rather than an afterthought, since new modalities frequently demand new ways of working on the floor. He's also skeptical that any single company can master every emerging modality at once—in his view, choosing a few areas to specialize in is quickly becoming a competitive necessity rather than an option.