Why Border Disruptions Threaten Blood-Derived Raw Materials—and What Biomanufacturers Can Do About It

Published on 24 June 2025

Reading time: 4 minutes

What happens when your biologics pipeline depends on the reliability of an international border?

For many manufacturers still using plasma-derived components like albumin or transferrin, that’s not a hypothetical. It’s baked into their supply chain.

Across the U.S.–Mexico border, more than 50 plasma centers depend on daily crossings from Mexican nationals to maintain a steady supply of plasma, a critical ingredient in biologics manufacturing. These dynamics play a major role in today’s blood plasma shortages and the instability of the global albumin supply chain. When the border tightens, the supply falters. During COVID-19, donations dropped dramatically. Prices soared. Production timelines slipped. Sound familiar?

This article breaks down the risks of relying on plasma from border-region donors and why it might be time to rethink your raw materials.

Real-World Supply Risk: Border Dependency Creates a Bottleneck

Let’s start with the numbers:

• Over 50 plasma centers are located within 50 miles of the U.S.–Mexico border.
• Many are strategically placed by companies like Grifols and CSL Plasma to target cross-border donors.

Why? Because U.S. law allows non-citizens with Border Crossing Cards to sell plasma, even though it’s illegal in Mexico.

Here’s the issue:

• These centers rely on daily donor crossings.
• A policy shift, legal challenge, or public health crisis can shut that down overnight.
• We’ve seen it happen. COVID-era restrictions caused caused a steep drop in plasma supply, intensifying the ongoing blood plasma shortage and creating procurement challenges for plasma-derived protein.

“This isn’t just a logistics issue. It’s a vulnerability embedded in your raw materials.” — Caroline Chen, Investigative Reporter, ProPublica

Regulatory and Ethical Exposure: Legal Loophole, Ethical Minefield

The system operates in a regulatory gray zone:

U.S. law prohibits non-citizens from selling whole blood—but plasma is treated differently. Under current rules, non-residents with Border Crossing Cards can donate plasma up to twice a week, so long as they meet minimum health and identification criteria. This loophole has enabled the growth of a border-dependent donor economy.

Here’s how it works:

• Many Mexican nationals living in low-income communities cross into U.S. border towns multiple times per week to sell plasma.
• Compensation typically ranges from $30 to $50 per donation—an amount that can significantly impact someone earning below the poverty line in Mexico.
• Companies like Grifols and CSL Plasma have built dozens of centers near the border to capitalize on this labor pool.

The consequences?

• Ethical concerns about coercion and informed consent: While legal, this practice raises difficult questions about whether individuals are donating voluntarily or out of economic desperation.
• Exploitation risks: Targeting financially vulnerable populations to extract biological materials—repeatedly, and for profit—blurs the line between compensation and commodification.
• Systemic fragility: When border policies change or donor eligibility tightens, supply drops overnight—as seen in 2021 when U.S. Customs began restricting donor entry.
• Legal volatility: Ongoing lawsuits from Grifols and CSL against the U.S. government underscore just how fragile and contested this sourcing strategy really is.

These weak points stack onto the existing risks of blood-derived raw materials—variability, regulatory exposure, and limited scalability.

“You’re essentially building your global biologics strategy on the backs of vulnerable populations.” — Dr. Lisa Eckenwiler, Bioethicist, George Mason University

Implications for Biomanufacturing: From Variability to Vulnerability

Still using blood-derived albumin?

In an industry increasingly moving toward animal-origin-free (and human-origin-free) biomanufacturing, relying on donor-based materials is an outdated liability.

Here’s what that exposes you to:

• Supply chain volatility tied to immigration, customs, and cross-border policy.
• Donor inconsistency that impacts performance, purification, and regulatory filing.
• Traceability concerns as regulators increase scrutiny on human-derived raw material.

These aren’t theoretical risks. They’re showing up in:

• Batch failure investigations
• Delayed IND submissions
• Quality audits asking tough questions about material sourcing

Historical Perspective: Plasma Supply is More Fragile Than It Looks

Disruptions in plasma availability aren’t new—and they’re not always caused by pandemics. The table below shows how regulatory decisions, production failures, demand spikes, and international dependencies have repeatedly strained global plasma supply:

Historical Disruptions in Plasma Supply (1975–2025)

🛑 Regulatory Issues Policy decisions that restrict donors or products	1975: WHO urges end to paid donations → fewer donors in key regions 1998: UK bans domestic plasma → becomes 100% import-dependent Late 1990s: FDA deferrals (e.g. vCJD) shrink U.S. donor pool 1997–1998: IVIG recalls and plant shutdowns cause supply gaps
🚧 Supply Chain Failures Breakdowns in collection, production, or distribution	1990s: Contaminated batches and plant issues trigger IVIG shortage 2020: COVID-19 causes an 18% drop in U.S. plasma collections Blood drives canceled during outbreaks and disasters Minimal stockpiles amplify even short-term disruptions
📈 Medical Demand Surges Clinical use increases faster than supply	Late 1990s: New uses for IVIG → demand exceeds supply by 30% 2010s: Immunoglobulin demand grows ~8% annually Aging populations + new therapies (neurology, immunology) strain output
🌍 International Dependency Reliance on plasma from a few major suppliers	1970s–80s: U.S. plasma exported worldwide → spread of HIV via tainted lots 2010s: Europe imports ~30% of plasma from U.S. → vulnerable to U.S. disruptions Low-income countries reliant on imports face frequent shortfalls Export restrictions and trade conflicts could worsen future access
📉 Donor Demographic Shifts Decline in long-term donor participation	2000s-2020s: Younger generations donate less frequently than older generations did at the same age 2010s: Cultural shifts and distrust of pharma have reduced participation in paid donation programs Long-term donor fatigue among repeat participants is accelerating in high-demand regions

Why Recombinant Alternatives Matter: Build Resilience into Your Process

This is where recombinant, animal-origin-free raw-materials change the game.

All InVitria’s recombinant human albumin and cell culture supplements are:

• Manufactured under cGMP
• Lot-to-lot consistent
• Free of donor dependencies
• Exempt from blood safety regulations
• Scalable from grams to metric TONS
• Ethically sourced and sustainable

That means:

• No exposure to border policy shifts
• No reliance on human donor networks
• No hidden ethical or regulatory risks

“Beyond quality, InVitrias recombinant solutions eliminate major sourcing liabilities.” — Scott Deeter, CEO, InVitria.

So what’s the takeaway?

If you’re still sourcing plasma-derived raw materials, you’re inheriting all the risk that comes with them: regulatory scrutiny, supply instability, and ethical uncertainty. Whether you’re facing a plasma-derived albumin shortage or broader concerns with the albumin supply chain, shifting to recombinant albumin isn’t just safer—it’s smarter.

Recombinant materials give you control. They future-proof your process. And they eliminate dependence on a supply chain built on fragile infrastructure and vulnerable donors.

It’s time to rethink your raw materials.

Talk with us about moving to recombinant.

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