A New Era of Fragility and Complexity
Global instability has become the new norm. From geopolitical tensions and pandemics to supply chain shocks, the traditional centralised, cost-optimised biotech manufacturing model has proven obsolete. Biotechnology is uniquely vulnerable – depending on specialised materials, sterile environments, and just-in-time coordination – making supply chain disruptions especially dangerous.
Yet having a global footprint doesn’t automatically translate into resilience. True robustness requires strategic design, not just geographic spread.
Lessons from Recent Disruptions
The past five years have delivered brutal lessons in supply chain vulnerability. COVID-19 created massive disruptions in raw materials, equipment, and labour, with specialised manufacturing sectors facing acute shortages of critical components. Post-pandemic recovery brought unexpected challenges: lead times doubled or tripled across industries as capacity constraints met surging demand.
The most surprising vulnerability proved to be global logistics itself. While companies routinely plan for supplier failures and capacity issues, the breakdown of intercontinental shipping – from port congestion to transport delays – caught many off guard. What had always been treated as reliable infrastructure suddenly became the weakest link.
The worst thing in our world is uncertainty. This uncertainty makes it impossible to make smart cash decisions or reliable customer promises. Companies found themselves investing heavily in safety stock, essentially throwing cash at inventory to buffer against unpredictable supply chains.
Cell and gene therapy manufacturing faced particular bottlenecks, with viral vector shortages and limited Good Manufacturing Practice (GMP) vector production capacity. Meanwhile, sterile injectable shortages – caused by FDA shutdowns over contamination – created widespread delays in monoclonal antibody launches and higher CMO pricing.
The Strategic Imperative: Multi-Regional Resilience
Smart manufacturers are now embracing multi-regional strategies that go beyond simple geographic diversification. The most effective approaches include:
Building Supplier Ecosystem Partnerships
Establishing secondary or tertiary suppliers across different political blocs while using digital platforms to monitor vendor health and capacity. Resilience has become the new efficiency. The companies that recognise this shift and invest accordingly will define the trajectory of manufacturing for the decade ahead.
The Compliance Complexity Challenge
An often-overlooked driver of supply chain transformation is the escalating burden of regulatory compliance. Companies now face significant investment requirements in product compliance infrastructure across multiple jurisdictions. From EU waste directives to regional chemical disclosure requirements, the regulatory landscape demands more than transactional supplier relationships.
This shift is forcing procurement strategies toward what industry professionals describe as “stickier and more trustful relations” with suppliers. The days of simply chasing the lowest cost are giving way to partnerships where suppliers can help certify regulatory compliance across evolving standards. Companies need suppliers committed to evolving alongside changing regulatory expectations, not just delivering components at the best price.
Strategic Nearshoring and Local Sourcing
The lesson from recent disruptions is clear: sites with regional supply chains proved more resilient than those requiring intercontinental movements. Companies are now increasing use of local suppliers for critical materials while co-locating key suppliers near manufacturing hubs to reduce transit risk and lead times.
Dynamic Inventory Management
Moving from “just-in-time” to “just-in-case” inventory strategies. Companies now maintain strategic stockpiles of high-risk components like filters, lipids, and sterile bags, rotating stock regularly to avoid obsolescence.
Regulatory Harmonisation
Designing facilities to meet the strictest overlapping standards (Food and Drug Administration and the European Medicines Agency) while maintaining validated tech transfer protocols between regions and proactively engaging regulators to streamline cross-border approvals during emergencies.
New Decision-Making Criteria
Traditional site selection focused primarily on cost optimisation. Today’s criteria have evolved dramatically. When considering new facilities, cost to operate remains a key component, but equally important is the potential location’s pool of skilled, willing, and able workforce – including competent talent for blue collar roles who will be depended on to physically make the product and professionals who will run all aspects of facility operations.
The secondary criteria focus on infrastructure maturity: ease of inbound/outbound transportation, stability and scale of local utilities, weather resiliency, and proximity to other established businesses that have complementary products or services.
This shift reflects hard-won lessons about the true cost of disruption. Companies are now willing to accept higher unit costs for lower supply risk, especially when total-cost models demonstrate the value of resilience over pure efficiency.
Technology as an Enabler
Digital transformation is enabling more sophisticated resilience strategies. Smart components with IoT interfaces, real-time supply chain visibility, and predictive analytics are becoming standard tools for managing distributed operations.
Key developments include automated bioreactor control systems, smart pumps with remote monitoring capabilities, and AI-driven process optimisation ensuring consistency across global sites. However, cybersecurity has emerged as a critical vulnerability, with digital systems becoming prime targets for attacks that can halt production.
Future-Proofing Against the Regulatory-Industrial Gap
Looking ahead, one of the most significant risks facing procurement professionals may be the growing disconnect between regulatory timelines and industrial innovation capacity. Well-intentioned regulations around environmental and health safety are increasingly outpacing industry’s ability to develop viable alternatives.
Consider this scenario: critical materials that enable specialised manufacturing processes face potential bans before replacement materials exist. Industries requiring chemical-resistant components, for example, depend on materials that are increasingly scrutinised by regulators. The first organisation to solve these material science challenges will gain substantial competitive advantage, but the transition period poses significant supply chain risks.
This regulatory-industrial synchronisation gap extends beyond any single sector. From automotive to electronics, industries face the challenge of maintaining functionality while adapting to evolving material restrictions. Procurement professionals must now factor in not just current compliance, but the trajectory of regulatory development and their suppliers’ innovation capacity.
The Competitive Advantage of Resilience
Supply chain robustness is no longer a back-office function – it’s core to product availability, pricing stability, and public trust. In a world of accelerating disruption, biotech companies investing in resilient, diversified, and digitally integrated global operations will not only survive but lead.
Advice for every CPO in 2026: take proactive actions to regularly validate your current reality with the ever-evolving view of the future. This will help you see when the right time exists to take a bold step in a different direction and will help your leadership team have clarity on where the biggest vulnerabilities exist.
Resilience has become the new efficiency. The companies that recognise this shift and invest accordingly will define the trajectory of biotech manufacturing for the decade ahead.