When COVID-19 swept the globe in 2020, it exposed vulnerabilities in supply chains that many industries had quietly ignored for years. For most sectors, disruption meant delayed deliveries or empty shelves. For plasma-derived medicinal products (PDMPs), it meant something far more consequential: threatened access to therapies that keep patients with rare diseases, immune deficiencies, and coagulation disorders alive.

Five years after COVID-19 disrupted global healthcare systems, many industries have returned to normal. Plasma-derived medicinal products (PDMPs) have not had that luxury. Demand for immunoglobulins, albumin, and coagulation factors continues to grow, while the structural constraints of plasma collection and fractionation remain unchanged. The next pandemic may not resemble COVID-19, but it will test the same question: how resilient is the plasma supply chain?

A supply chain unlike any other

Plasma cannot be synthesized, stockpiled indefinitely, or sourced from an alternative supplier. It is drawn from human donors, pooled in the tens of thousands, and processed through a manufacturing cycle that typically runs between 7 and 12 months from donation to finished product.[1] A single batch may represent the contributions of up to 50,000 donors.[2]

This creates a supply chain with very limited capacity for reactive response. Disruptions to collection do not register in finished product supply for the better part of a year. By that point, the ability to intervene is already constrained.

The scale of the market reinforces why this matters. In 2022, an estimated 16.5 million people received a plasma-derived product globally, with demand for immunoglobulin (IgG) and albumin growing at a compound annual rate of 12 to 14 percent.[2] Global plasma for fractionation is forecast to reach 90 million liters by 2026, with immunoglobulin demand projected at 360 tonnes.[2] Four fractionators currently account for 75 percent of a $35 billion market.[2] That concentration represents a structural vulnerability.

What COVID-19 revealed

The pandemic did not introduce weaknesses into plasma supply chains; it made existing ones visible. Collection volumes fell sharply in early 2020 as donor centers closed and public movement was restricted. Source plasma, which depends heavily on paid donors in the United States, was particularly affected. Recovered plasma faced additional pressure as elective procedures were cancelled and healthcare systems absorbed the surge in demand.[5]

The interdependence of global manufacturing networks also became apparent. Plasma collected in one country is routinely shipped to fractionation facilities in another, then distributed as finished product across multiple markets. Restrictions at any point in that sequence can affect supply in ways that are slow to resolve.[4]

Industry discussions following the pandemic focused on geographic diversification, strategic buffer stocks, and reducing dependence on a small number of collection geographies. Progress has been made, but the structural issues that COVID-19 highlighted have not been fully resolved.

Today's supply chain threats extend beyond public health emergencies. Geopolitical tensions, trade restrictions, transportation disruptions, cyberattacks, energy security concerns, and climate-related events can all affect global manufacturing networks. For plasma-derived therapies, where collection, fractionation, purification, and distribution frequently occur across multiple countries, resilience increasingly depends on geographic diversity and operational flexibility.

Building resilience across the supply chain

Resilience in plasma supply depends on progress across three areas: geographic reach, manufacturing continuity, and downstream process reliability.

• Geographic diversification is advancing. New collection and fractionation capacity is being established in Croatia, Indonesia, Malaysia, Poland, Romania, Turkey, Ukraine, and Uzbekistan, among others.[2] Broadening the geographic base reduces exposure to localized disruption, whether from public health emergencies, regulatory changes, or logistical constraints.
• Manufacturing continuity requires sustained investment in facilities and the supplier networks that support them. A modern plasma fractionation facility is operationally complex, incorporating around 1,000 process devices, 35 kilometers of pipework, and 6,000 valves across a footprint of approximately 31,750 square meters.[2] Maintaining reliable operations across that infrastructure depends on reliable supply of critical consumables and process inputs.
• Downstream process reliability is the area where supply risks are often least visible. Chromatography resins and other purification materials are integrated into validated manufacturing processes that require significant regulatory work to modify. A failure in the supply of a critical resin does not produce an immediate disruption, but its effects accumulate and can be difficult to reverse once they take hold.[6]

The role of technology partners

Supply chain resilience is often discussed in terms of plasma collection networks, fractionation capacity, and finished product inventories. Yet resilience depends on every layer of the manufacturing ecosystem, including the technologies and materials embedded within licensed production processes.

The COVID-19 pandemic highlighted that resilience depends not only on access to plasma, but also on the ability to sustain validated manufacturing operations. For plasma fractionators, changing a critical process material can require significant regulatory and technical effort, making supplier reliability an important component of business continuity planning.

As a result, manufacturers increasingly evaluate technology partners based on capacity, manufacturing footprint, inventory strategies, and long-term supply commitments as part of broader risk management frameworks.

At Astrea Bioseparations, supporting customers with reliable supply continuity is treated as a core operational requirement. With more than three decades supporting plasma purification processes and manufacturing capacity expanded on the Isle of Man, our focus extends beyond product performance to long-term reliability, regulatory support, and lifecycle partnership.

One lesson from recent disruptions is that resilience cannot be added at the end of a supply chain. It must be designed into every component of the manufacturing ecosystem. The strongest supply chains are built not only on capacity, but on trusted partnerships that support reliability over the long term.

From supplier to strategic partner

For plasma manufacturers, supplier selection is about more than product performance. It requires confidence that a partner can support validated processes over the long term, maintain regulatory expectations, and provide continuity through periods of disruption. Experience within plasma-derived therapeutics is particularly important, given the complexity of process changes and the long lifecycle of licensed manufacturing operations.

Astrea Bioseparations has worked alongside plasma fractionators for more than three decades, supporting purification technologies that have been incorporated into licensed plasma manufacturing processes worldwide. This experience spans process development, validation, commercial manufacturing, and lifecycle support, providing insight into the operational and regulatory realities that shape plasma production. As demand for plasma-derived therapies continues to grow, the ability to combine technical expertise with long-term supply assurance becomes an increasingly important element of industry resilience.

Preparedness requires coordination

No single company, facility, or technology can make a supply chain pandemic-proof. It is a system-level property that depends on action across fractionators, collection organizations, national health systems, and technology suppliers.

Fractionators need multi-site capability and geographic diversification. National health systems need to maintain strategic stocks of critical PDMPs. Collection organizations need to expand donor bases and build redundancy into logistics. Technology suppliers, working alongside manufacturers and healthcare stakeholders, need to treat security of supply as a primary consideration in manufacturing planning. The industry has a precedent for this kind of coordinated response. The viral contamination crisis of the 1980s prompted the development of inactivation and removal technologies that now achieve total viral clearance factors exceeding 14 log₁₀.[3] That response required investment across multiple organizations and disciplines. Building supply chain resilience presents a comparable challenge.

As John Curling and colleagues noted in their 2025 review of the past, present, and future of blood plasma fractionation, the field is moving toward bioprocessing 4.0: digitally integrated facilities, real-time traceability, and automated manufacturing.[2,7] These developments support resilience by enabling faster responses to disruption and more consistent performance across manufacturing sites.

Resilience is an ongoing challenge

Are we ready for another pandemic?

The honest answer is, we’re more ready than we were in 2020, but not yet as ready as we need to be. The vulnerabilities that COVID-19 exposed have not been fully addressed.

Geographic diversification is progressing, manufacturing investment is continuing, and awareness of supply chain risk is higher. At the same time, the fundamental constraints of plasma manufacturing have not changed. Lead times remain long, validated processes remain difficult to modify, and concentration in the fractionation market remains a risk factor.

At Astrea Bioseparations, we work with plasma fractionators as long-term partners, supporting process development, validation, and supply continuity across manufacturing lifecycles. Our focus is on providing technologies that perform reliably at scale and can be sustained over time, including through periods of external pressure.

Plasma-derived therapies are essential medicines. The patients who depend on them need a supply chain designed to withstand disruption, not just perform efficiently under normal conditions. Preparing for the next disruption is an ongoing requirement, and one that the industry needs to continue addressing.

References

1. Plasma Protein Therapeutics Association (PPTA). Plasma collection and manufacturing. Available at: https://www.pptaglobal.org/resources/plasma-collection-and-manufacturing 
2. J, Farrugia A, von Bonsdorff L. The past, present and future of blood plasma fractionation. Biologicals. 2025 Jun 28;91:101849. doi: 10.1016/j.biologicals.2025.101849. Epub ahead of print. PMID: 40582323. [Presented at IPFA/EBA Plasma Collection and Supply, Leuven, Belgium, 11–12 February 2026]
3. Farrugia A. The Evolution of the Safety of Plasma Products from Pathogen Transmission — A Continuing Narrative. Pathogens. 2023 Feb 15;12(2):318. doi: 10.3390/pathogens12020318. PMID: 36839590; PMCID: PMC9967166.
4. von Bonsdorff L, Farrugia A, Candura F, O'Leary P, Vesga MA, De Angelis V. Securing commitment and control for the supply of plasma derivatives for public health systems. I: A short review of the global landscape. Vox Sang. 2025 Feb;120(2):114–123. doi: 10.1111/vox.13758. PMID: 39477346; PMCID: PMC11839246.
5. Turecek PL, Hibbett D, Kreil TR. Plasma procurement and plasma product safety in light of the COVID‐19 pandemic from the perspective of the plasma industry. Vox Sang. 2022 Jun;117(6):780.
6. CRB Group. Trends in the Plasma Manufacturing Industry. Available at: https://www.crbgroup.com/insights/pharmaceuticals/trends-plasma-manufacturing-industry
7. Farid SS, Dikicioglu D, Goldrick S, Lye GJ. Delivering the digital skills needs of the bioprocessing sector: realizing the vision of Industry 4.0 for your organization. BioProcess International. 2023;21(1-2):20–25.