Building Robust Biomanufacturing Networks for the Next Wave of Therapies

The past few years have been a stress test for biomanufacturing and the biopharmaceutical industry as a whole. Global supply chain pressures, policy volatility, and the surge in advanced therapies have revealed just how fragile some parts of the manufacturing networks are. However, these factors have also shown where the next wave of opportunity lies. The current growing pains are a preview of the demands that will define the future of the industry.

Since the COVID-19 pandemic era, industry participants have seen how overreliance on foreign supply chains leaves biomanufacturers exposed. With the ongoing tariff threats and shifting trade policy, this vulnerability remains true today and has only created greater risk for companies heavily dependent on imports. While broader macroeconomic conditions have influenced manufacturer performance, recent reporting shows uneven results across divisions and modalities alongside cascading delays driven by bottlenecks in critical supplies like plasmid DNA (1). Vector-based gene therapies and messenger RNA (mRNA) vaccines rely on these materials, and variability, supply constraints, and cost escalation have slowed development timelines and delayed programs at pivotal moments when speed matters most.

Overreliance on single manufacturing increases operational risk during demand surges (2,3). Many facilities designed for large-scale blockbusters have struggled to adapt to the needs of small-batch manufacturing for gene therapies, orphan drugs, and complex biologics (2).

However, disruption has a way of accelerating innovation. The industry is now seeing multi-site networks built across geographies and modalities, creating the redundancy needed to withstand policy shocks or regional disruptions (2,3). As the demand for personalized medicines continue to rise, facilities for small-batch work are proving that agility and sterility can coexist (3).

The surge in investment activity and billion-dollar valuations (4) across the contract development and manufacturing organization (CDMO) space demonstrate that resilience and flexibility are core assets in the current market. While vulnerabilities remain, the industry is actively addressing them by embedding redundancy, digitizing operations, and localizing critical supply (3) With these obstacles, the industry has renewed focus on building a more reliable, agile foundation for future therapies.

How is the industry building resilient and redundant networks?

The next wave of advanced treatments, like gene therapies and personalized biologics, will require resilient and redundant networks capable of rapid but sustainable scale.

Multi-site frameworks

By spreading operations across multiple geographies and modalities, organizations can ensure continuity even if one region or capability faces disruption. Investors have emphasized the value of CDMOs with global footprints and site redundancy as a key resilience asset. Dual region options both within the United States and abroad, strategic capacity reservation, and hybrid risk-sharing contracts can blunt tariff impacts or funding shocks. When selecting partners, it is important to value networks that combine global redundancy with localized responsiveness.

Localized sourcing and CDMO alignment

To scale without interruption, the industry needs facilities dedicated to materials production and increased domestic capacity to prevent global disruption. Resilient networks depend on localized and secure supply sourcing for critical inputs like plasmid DNA or fill/finish services. Tariff pressures are driving investment back into domestic capacity, but the rationale goes beyond politics. Localized capacity and supply of critical materials address bottlenecks and improve consistency while keeping timelines intact. Misalignment between drug sponsors and CDMOs can also delay programs, so it is important that both sides choose for fit as well as footprint. Treating CDMOs as co-developers and prioritizing scientific depth, regulatory credibility, and intellectual property trust are qualities that are equally critical to technical capability. These qualities can be the difference between smooth tech transfer and program delays.

Agile facility design

As the industry plans for the increasingly personalized nature of future therapies, it must start by building small-batch flexibility to avoid delays. Major blockbuster facilities that weren’t designed for low-loss filling and multiple container formats have struggled with bottlenecks and waste, particularly as the industry shifts toward small-batch, high value biologics and other patient specific therapies (5). Designing for precision and manufacturability earlier in the candidate stage can help prevent these pitfalls. Resilient networks need modular, digitally integrated facilities that can switch between products, scales, and formats quickly. For advanced biologics and gene therapies, specialists point to the need for filling lines that minimize product loss and adapt across formats, supported by isolator technology and robust contamination controls. This enables facilities to pivot quickly between products and adapt without sacrificing compliance (2).

These key strategies form the backbone of a manufacturing network that can adapt, withstand macroeconomic shocks, and continue improving access for patients. Resilience, however, also depends on anticipating risks before they disrupt operations. Digital innovation is rapidly becoming a cornerstone of proactive and agile processes.

How do digital tools mitigate risk?

Through the rise of artificial intelligence (AI), industry participants are seeing a digital evolution and transformation in manufacturing. Risk mitigation is moving beyond reactive systems toward digital-first strategies(3,6). AI-enabled tools like digital twins are being developed for fault detection and predictive maintenance, and can be extended to quality monitoring, production scheduling, and resource planning (3,6,7). These tools help de-risk scale-up, validate changes, and reduce deviations through scenario simulations.

By creating virtual replicas of manufacturing plants, these tools detect anomalies before they escalate or disrupt operations. Broader digital twins go even further by simulating business processes, monitoring compliance, and testing what-if scenarios across entire operations (3,6,7).

Efficiency gains can be substantial, with digitization and advanced analytics reducing manual documentation, accelerating quality testing workflows, and lowering the overall operational burden of quality control (7). Experts are speculating that AI-driven and even quantum digital twins may eventually enable lights-out factories with self-correcting systems (7).

Real-time data is the lifeblood of these systems. By mirroring the state of equipment and processes, teams can respond almost instantly. That capability is transforming maintenance from scheduled to predictive, catching wear or contamination before it disrupts production. Predictive analytics allow teams to strengthen risk assessments under good manufacturing practice frameworks while providing leadership visibility into operational and compliance risks.

These technologies shift risk management from reactive to proactive, transforming how biomanufacturers monitor and optimize production. As the landscape becomes increasingly more digital and domestic capacity grows, it’s critical that guidance keeps pace with technology. Harmonization between regulators and industry ultimately lowers cost and speeds access.

Recent years of global supply chain challenges have tested industry resilience, but they’ve also accelerated critical innovation that will support the therapies of tomorrow. The next wave of advanced therapies will require enhanced precision and agility from developers beyond what has been seen in the past. The robust advanced therapy pipeline demonstrates the industry’s strength in innovation, but the true test is delivering those breakthroughs reliably every time. Bolstering the physical and digital infrastructure that make up today’s manufacturing networks will ensure that patients can count on timely, reliable access to these innovative therapies.

References

1 Ohlson, J. Plasmid Manufacture Is the Bottleneck of the Genetic Medicine Revolution. Drug Discovery Today 2020, 25 (11), 1891–1893. DOI: 10.1016/j.drudis.2020.09.040
2. ICH, Q9 Quality Risk Management, Step 5 version (2023).
3 FDA. Distributed Manufacturing and Point-of-Care Manufacturing of Drugs. FDA.gov (accessed Dec. 16, 2025).
4. Barnes, O.; Gara, A. Permira Seeks $4bn for Sale of Contract Drugmaker Cambrex. Financial Times online, Sept. 6, 2025.
5. Sarkis, M.; Bernardi, A.; Shah, N.; Papathanasiou, M. M. Emerging Challenges and Opportunities in Pharmaceutical Manufacturing and Distribution. Processes 2021, 9 (3), 457. DOI: 10.3390/pr9030457
6. Chen, Y.; Yang, O.; Sampat, C.; et al. Digital Twins in Pharmaceutical and Biopharmaceutical Manufacturing: A Literature Review. Processes 2020, 8 (9), 1088. DOI: 10.3390/pr8091088
7. Han, Y.; Makarova, E.; Ringel, M.; Telpis, V. Digitization, Automation, and Online Testing: The Future of Pharma Quality Control. mckinsey.com, Jan. 4, 2019.

About the author

Anshul Mangal is CEO of Project Farma and president of PerkinElmer OneSource.