Beyond the giant factory: Why the future of biomanufacturing is agile, distributed and resilient

Biologics manufacturing is entering a new phase where agility and proximity are as important as scale. For decades, the industry has operated under the “bigger is better” philosophy, building large-scale, centralized facilities to reduce unit costs. However, the ground beneath our feet is changing.

The ever-expanding portfolio of biopharmaceuticals determines this shift. The number of proteins entering Phase 1 clinical trials has doubled in the past 15 years, and 50% of new biologics are rare or orphan drugs, highlighting the need for flexible manufacturing. We are moving from a world of only large tracts to a world defined by fragmentation and precision. At the same time, biomanufacturing infrastructure is becoming increasingly limited.

To meet the growing demand for biological products, biotech innovators require high-quality, cost-effective production and innovative methods to enable low-volume manufacturing capabilities. While traditional centralized facilities will continue to play an important role, early market and regulatory signals indicate an increasing shift toward smaller, regional facilities that can respond more quickly to demand, supply disruptions and emerging treatment needs.

Growing demand for personalized and rare disease treatments requires a transition to a regulatory framework that supports distributed biomanufacturing through technological innovation. Current geopolitical instability highlights the critical importance of distributed production to maintaining health resilience and ensuring patient access in every country.

Centralized production is showing its limitations

The “giant factory” model was built for a stable world, but stability is currently in short supply. Ongoing supply chain disruptions and parts shortages continue to expose the vulnerabilities of single-site, globally dependent operations.

The impact on patients is measurable and shocking. Chronic and persistent shortages account for more than 90% of all drug shortages in the United States, with the current average duration of shortages exceeding four years.

When we rely heavily on centralization, clinical and commercial projects become slower and slower because necessary materials, equipment, or outsourced processes become bottlenecks. For example, delays in raw material delivery can delay shipments of critical biologics for months, impacting patient access.

Large facilities remain critical for high-volume indications, but their size and complexity make rapid adaptation difficult, forcing organizations to choose between throughput and flexibility. Building a traditional biomanufacturing facility typically takes three to five years and more than $200 million. These types of facilities are often built for a single product type and cannot quickly adapt to changes in product demand.

These pressures are forcing companies to reconsider whether centralization can meet the pace and diversity of the modern biologics pipeline. As market demands for precision medicine, rare disease treatments and low-volume biologics become more prevalent, centralized facilities alone may not be enough to meet diverse, pressing patient needs.

The rise of flexible biofabrication

The solution to this rigidity lies in the use of reinforcement and continuous processing. Advances in modular, enclosed and automated systems allow smaller facilities to operate consistently and reduce staffing requirements.

Compared with traditional batch processes, continuous manufacturing has significant advantages, including up to 70% reduction in equipment footprint, 3 to 5 times increase in volumetric productivity, improved product quality consistency, and 30-50% reduction in equipment costs. These indicators make distributed production economically feasible and operationally beneficial.

Importantly, global regulatory agencies are increasingly accepting modular, single-use and continuous production systems for clinical and commercial supply, reducing barriers to regional deployment. We're seeing innovative manufacturers around the world proving that this approach can deliver high-quality treatments and be good business.

For example, in the third quarter of 2025, WuXi Biologics announced that its Irish facility received approval from the European Medicines Agency (EMA) as a commercial manufacturing site for biologics for global customers, one of the largest cell culture processes in the world using single-use technology. The facility deployed the WuXiUp platform for pilot-scale automated continuous drug substance (DS) manufacturing, demonstrating that single-use continuous technology can meet stringent regulatory standards.

Another example is Enzene Biosciences' EnzeneX technology, the first fully connected continuous manufacturing (FCCM) approach validated for commercial biologics supply. Enzene recently (September 2025) opened a new facility in Hopewell, New Jersey, which will deploy the EnzeneX platform. Standardization between sites allows them to move processes from their R&D center in Pune, India, to a location in New Jersey with minimal friction, embodying the “exact copy” model required for distributed networks.

Finally, BiosanaPharma deployed their “3C” process – Continuous, Contained and Compact – to achieve a huge milestone by producing the first monoclonal antibody (a biosimilar to omalizumab) manufactured using a fully continuous process to enter Australian clinical trials. They are now working to help third parties, including bioinnovators and CDMOs, deploy 3C platforms to improve the efficiency of existing facilities.

Conclusion: A turning point in biofabrication

Personalized and highly targeted treatments are becoming more common, making local or regional production increasingly valuable for getting patients faster. This highlights how hybrid networks combining large centralized factories with flexible regional sites will define the next era of resilient biomanufacturing.

Biomanufacturing will not become decentralized immediately, but the trend is clear. Emerging technologies, regulatory developments, and changing treatment needs are driving the industry toward a more distributed approach. It is critical that regulators and manufacturers collaborate to define quality risk management standards for distributed manufacturing—a critical step in ensuring patient access to biologics around the world.

Companies that start preparing now by modernizing their platforms, exploring modular facility designs, and identifying areas where regional capabilities can increase resiliency will be better able to meet future demands. The next phase of biologics manufacturing will be defined by flexibility, proximity, and the ability to get treatments to patients faster.

Photo: nevarpp, Getty Images

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