Building Flexibility into Biopharma Manufacturing

As biopharma pipelines become more complex and market conditions continue to evolve, manufacturers are rethinking how they scale capacity, deploy capital, and build supply chains. The industry’s focus is increasingly shifting toward developing the flexibility, resilience, and specialized capabilities needed to support rapidly evolving therapeutic modalities. At the same time, regionalization efforts, supply chain pressures, and changing sponsor expectations are prompting both CDMOs and drug developers to reassess long-term manufacturing strategies. In this episode of Off Script, we spoke with Sebastián Arana, executive vice president and global head of process solutions at MilliporeSigma, about the forces reshaping the biopharma CDMO landscape. The conversation explores the industry’s shift from a capacity-driven market to a capability-driven one, how sponsors’ expectations around speed and flexibility are changing manufacturing partnerships, and why process characterization, tech transfer, and supply chain coordination remain persistent scaling challenges. Arana also discusses the growing trend toward retrofitting existing facilities for multi-modality production, the rise of region-for-region manufacturing strategies, and more.