Biologics manufacturing is entering a new phase where agility and proximity matter as much as scale. For decades, the industry relied on the philosophy that “bigger is better,” constructing massive, centralized facilities to drive down unit costs. However, the ground is shifting beneath our feet.
The expanding portfolio of biologic drugs dictates this shift. Over the past 15 years, the number of proteins entering Phase 1 clinical trials has doubled, and 50 percent of new biologics are rare or orphan drugs, highlighting the need for flexible production. We are moving away from a blockbuster-only world toward one defined by fragmentation and precision. Meanwhile, biomanufacturing infrastructure has become increasingly limited.
To meet this accelerating demand for bioproducts, biotech innovators need high-quality, cost-effective approaches to production and innovations that enable small-volume manufacturing capacity. While traditional centralized facilities will continue to play a major role, early market and regulatory signals point to a growing shift toward smaller, regional sites that can respond faster to demand, supply disruption, and emerging therapeutic needs.
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The rising demand for personalized and rare-disease therapies necessitates a transition toward regulatory frameworks that support distributed biomanufacturing through technological innovation. Current geopolitical instability underscores that distributed production is critical for maintaining every nation’s health resilience and guaranteeing patient access.
Centralized production is showing its limits
The “mega-factory” model was built for a stable world, but stability is currently in short supply. Ongoing supply chain disruptions and component shortages continue to expose weaknesses in single-site, globally dependent operations.
The impact on patients is measurable and alarming. Long-standing, persistent shortages account for more than 90% of all drug shortages in the United States, with the average duration of current shortages now over four years.
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When we rely heavily on centralization, clinical and commercial programs are increasingly slowed because essential materials, equipment, or outsourced processes become bottlenecks. For instance, delays in raw material delivery can push critical biologics shipments back by months, impacting patient access.
Large facilities remain essential for high-volume indications, but their size and complexity make rapid adaptation difficult, forcing organizations to choose between throughput and flexibility. It typically takes three to five years and over $200 million to build conventional biomanufacturing facilities. These types of facilities are often built for a single product type and cannot rapidly adapt to changes in product demand.
These pressures are forcing companies to reconsider whether centralization can meet the pace and diversity of modern biologics pipelines. As the market demand for precision medicine, rare disease therapeutics, and small-batch biologics become more prevalent, centralized facilities alone may not suffice to meet diverse, urgent patient needs.
The rise of flexible biomanufacturing
The solution to this rigidity lies in the adoption of intensified and continuous processing. Advances in modular, closed, and automated systems allow smaller facilities to operate with consistency and lower staffing requirements.
Continuous manufacturing offers substantial benefits, including a reduced equipment footprint of up to 70%, a 3- to 5-fold increase in volumetric productivity, enhanced product quality consistency, and facility cost reductions of 30–50% compared to traditional batch processes. These metrics make distributed production economically feasible and operationally advantageous.
Importantly, global regulators are increasingly accepting modular, single-use, and continuous production systems for clinical and commercial supply, reducing barriers for regional deployment. We are seeing innovative manufacturers worldwide prove that this approach delivers high-quality therapeutics and is good business.
For example, in Q3 2025, WuXi Biologics announced that its Ireland facility was approved by European Medicines Agency (EMA) as a commercial manufacturing site for a global client’s biologic–one of the largest cell culture processes using single-use technology worldwide. This site deploys the WuXiUp platform for automated continuous drug substance (DS) manufacturing at pilot-scale, demonstrating that single-use continuous tech can meet rigorous regulatory standards.
Another example is Enzene Biosciences’ EnzeneX technology, which was the first fully-connected continuous manufacturing (FCCM) approach validated for commercial biologics supply. Enzene recently (September 2025) inaugurated a new facility in Hopewell, New Jersey that will deploy the EnzeneX platform. This standardization between sites allows them to transfer a process from their R&D center in Pune, India, to their New Jersey location with minimal friction, epitomizing the “copy-exact” model necessary for a distributed network.
Finally, BiosanaPharma has deployed their “3C” process — Continuous, Closed, and Compact — to achieve a massive milestone by producing the first monoclonal antibody (a biosimilar of omalizumab) manufactured with a fully continuous process to enter clinical trials in Australia. They are now working to help third parties, including biologic innovators and CDMOs, deploy the 3C platform to get improved efficiency from existing facilities.
Conclusion: A turning point for biomanufacturing
Personalized and highly-targeted therapeutics are becoming more common, making local or regional production increasingly valuable for faster patient access. This underscores how a hybrid network combining large, centralized plants coupled with flexible regional sites will define the next era of resilient biomanufacturing.
Biomanufacturing will not become decentralized immediately, but the trends are clear. Emerging technologies, regulatory developments, and shifts in therapeutic demand are driving the industry toward a more distributed approach. Crucially, regulators and manufacturers must partner to define quality risk management standards for distributed manufacturing — a vital step in securing global patient access to biologics.
Companies that begin preparing now by modernizing platforms, exploring modular facility designs, and pinpointing where regional capacity could strengthen resilience will be better positioned to meet future needs. The next phase of biologics production will be defined by flexibility, proximity, and the ability to deliver therapies to patients more quickly.
Photo: nevarpp, Getty Images
Dr. Kerry Love is the co-founder and CEO of Sunflower Therapeutics, a women-owned and led biotechnology company delivering next-generation protein manufacturing solutions that anyone can use to create innovative new medicines, vaccines, foods, and other bio-produced materials. Kerry is an organic chemist by training, performing her doctoral studies at MIT, and a biotech entrepreneur at heart, having founded two companies and contributed to the starting of many more over the past twenty years.
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