Single-sourcing risks revealed by pharma's pandemic supply chain crisis

Single-Sourced And Exposed: The Procurement Lesson Buried In Pharma’s Pandemic Supply Chain Crisis

COVID-19 didn’t just disrupt clinical manufacturing – it exposed a sourcing-strategy failure that procurement and supplier relationship management teams outside biotech should recognize immediately.
By Lisa Cozza and Bill Connell, Tunnell Consulting

Every procurement organization eventually confro...

nts the same reckoning: sourcing decisions that looked efficient on a spreadsheet carry hidden risk the moment a single supplier can’t deliver. Clinical-stage biopharma hit that reckoning hard during COVID-19, and the lesson speaks to procurement and supplier relationship management teams as much as to clinical operations.

Single-use technologies – disposable bags, bioreactors, tubing assemblies, and filtration systems – are now the default manufacturing platform for clinical-stage biologics. They give CDMOs and sponsors flexibility and rapid changeovers without major capital investment. The advantages are real. The vulnerability sat elsewhere: in how many programs sourced those components from a single supplier. When global supply chains fractured, that dependence put investigational product supply, and by extension trial continuity, at serious risk. The U.S. government’s DX and DO priority designations made it worse: on-market lifesaving products received top-priority access while clinical trial programs, lacking commercial purchasing power and supplier relationships, were deprioritized precisely when they could least afford it.

What The Pandemic Revealed About Investigational Supply Risk

The 2020–2021 shortages were not primarily a logistics failure; they were a strategic failure years in the making. Sponsors and CDMOs had concentrated single-use sourcing around single suppliers, drawn by pricing leverage and the simplicity of fewer vendor relationships. Pricing incentives from leadership often overruled SME recommendations for diversification. When suppliers hit capacity limits, there were no qualified alternatives to pivot to. Enrolment schedules slipped; some programs were put on hold.

The regulatory dimension compounded it. In IND and early BLA submissions, many sponsors had described single-use components in granular detail – not just materials of construction and performance parameters, but specific manufacturers and catalogue configurations. That specificity, intended to demonstrate manufacturing control, became a constraint: substituting a functionally equivalent component required a regulatory amendment, and approval sometimes took longer than the trial could tolerate. One of us served on an industry materials task force during the pandemic and saw this first-hand – the inability to manoeuvre translated directly into manufacturing gaps that delayed dose preparation and threatened active trials. Clinical supply chains have less slack than commercial ones: narrow enrolment windows, finite shelf life, and a missed supply cycle that can trigger a protocol deviation or a trial hold.

Second-Sourcing Is Not Optional, Even In Clinical

The corrective is straightforward in principle: when clinical manufacturing depends on critical single-use components, you need a qualified second source or a viable alternative manufacturing approach. During the pandemic, sponsors whose INDs were drafted broadly enough to permit traditional stainless-steel equipment could often pivot; those locked into over specified submissions could not. Keeping IND language broad, supported by performance data rather than specific vendor designations, is the most effective supply chain insurance a clinical team can build at the filing stage. Treating second-sourcing as a commercial-stage concern is a serious planning error: a disruption in Phase 2 or Phase 3 – stalled enrolment, protocol violations, a forced trial hold – can cost as much as a post-approval shortage, and sometimes more. Resilience planning must begin when clinical manufacturing begins.

The qualification burden is real and should be scoped into timelines and budgets. Extractables and leachables testing is not a simple matter of swapping one plastic bag for another; polymer sourcing, manufacturing geography, and processing aids all affect a component’s extractable profile. Formal studies are not required until a final process is set at Phase 3, but early teams should run high-level extractables screening on drug-substance contact materials before a switch is forced under pressure. Global sourcing adds complexity: components that look standardized on paper vary across a supplier’s North American, European, and Asian facilities, and qualification must confirm genuine equivalence, not nominal membership in the same product family. Smaller innovators without material review boards often accept a supplier’s equivalence claim unverified – an oversight that can surface as a comparability problem in later-phase submissions.

Smarter IND Filing Strategies For Clinical Supply Flexibility

IND filing strategy must be designed with supply chain contingency in mind from the start. The appropriate level of description for a single-use component is its materials of construction, intended function, and general design characteristics – not the specific manufacturer, size, or catalogue number. Where a material is genuinely critical to product quality or patient safety, the filing should name two qualified sources, not one. Filing strategy and supply chain strategy must be developed in parallel; a filing team making component decisions without sourcing input should be a red flag in any program review. FDA reviewers do not want submissions locked into configurations that cannot adapt as a multiyear trial progresses – describing function and performance parameters preserves operational flexibility while giving regulators the assurance they need on quality and safety.

Technology Selection: Rethinking The Clinical Default

Single-use is not the right answer for every scenario, and its default status deserves scrutiny. Planners choose it early because it minimizes capital and simplifies changeover – both valid – but that choice is rarely revisited as programs advance. Roughly 90% of Phase 1 programs never reach commercial approval, so heavy investment in permanent single-use infrastructure at the outset is often premature; preserving the flexibility to switch platforms is itself a form of resilience. For late-stage trials at near-commercial volumes, continued single-use dependence warrants honest reassessment. Handling matters too: assemblies manageable at small volumes become unwieldy at scale, connections reliable at 200 liters grow difficult at 2,000, and fold-line failures on unpacking are physical realities, not process errors. Disposal and large-scale setup costs also weigh on COGS, an underappreciated offset to single-use’s perceived economic advantage.

What Industry Data Is Telling Clinical Supply Teams

The vulnerability is well documented. Cytiva’s 2025 Global Biopharma Index (1,250 executives across 22 countries) found more than 75% of leaders expect geopolitical volatility to reshape their sourcing strategies, and nearly half report difficulty finding high-quality CDMO and CRO partners. One in four said their organization would be slow to scale key modalities , cell and gene therapies, mRNA – that dominate clinical pipelines; overall resilience fell to 5.96 out of 10 in 2025 from 6.60 in 2021. A February 2025 Biotechnology Innovation Organization survey found 90% of U.S. Biotechs rely on imported components for most FDA-approved products, with 94% forecasting higher costs from potential EU tariffs alone. The Pharma and Biopharma Outsourcing Association notes a surge scenario like 2020–2021 would hit clinical capacity before commercial, because clinical programs have less purchasing power. ISPE’s Drug Shortages Prevention Plan names second-sourcing of critical materials as a foundational element of resilient supply – a baseline for clinical development, not an advanced capability reserved for commercial operations.

Building Clinical Supply Chains That Can Withstand Disruption

More disruptions will come – geopolitical events, natural disasters, pandemics, or the routine realities of supplier consolidation and capacity constraints. For clinical programs, scrambling carries a direct cost: a delayed trial is a delayed development timeline, with compounding consequences for regulatory milestones, competitive position, and patients waiting for access. Preparedness means treating resilience as a design requirement from the outset – second-sourcing critical components before you need them, structuring IND submissions to preserve flexibility, and building supplier relationships deep enough that clinical programs are prioritized, not deprioritized, when capacity is scarce. It also means being honest with development leadership about cost and timeline: qualifying a second supplier in Phase 2 takes budget and analytical resources, but those investments compare well against a trial put on hold, a protocol amendment, or a slipped readout milestone.

The pandemic was an extreme case, but the vulnerability it exposed is not confined to pharma. Any procurement function that has let unit cost and vendor simplicity drive sourcing, without a qualified second source and the contractual flexibility to activate it under pressure, carries the same exposure. Biologics manufacturing simply happened to be where the bill came due first. For sponsors, CDMOs, and the supplier relationship management functions that support them, investigational product supply is not simply a manufacturing problem. It is a trial continuity problem, and, more broadly, a sourcing strategy problem. The decisions that determine whether a supply chain can withstand disruption are made in development and procurement planning, not in a crisis.

About The Authors:

Lisa Cozza and Bill Connell are principals at Tunnell Consulting, specializing in outsourced manufacturing strategy, supply chain risk management, and CDMO relationship optimization for biopharmaceutical companies.