A Case For Paying Allogeneic Cell Therapy Product Donors

By Jennifer Chain, Ph.D., CABP, cellular starting material expert, and Stephen McClung, MBA, plasma center operations expert

For over 80 years, the world has quietly built two parallel blood supply ecosystems. The first, rooted in the non-compensated donor model, relies on altruistic volunteers to furnish blood components for direct patient transfusion. The second — a rapidly growing biologics collections network — relies on compensated donors who supply plasma for manufacturing lifesaving medicines and, more recently, cellular starting material for advanced allogeneic therapies. Understanding the history, real-world impacts, and future demands of donor compensation is essential as the cell therapy manufacturing network expands. The ethical, operational, and regulatory lines between the compensated and non-compensated ecosystems are often blurred in public discourse. This article seeks to clarify those lines and argues that fair compensation is not only compatible with donor dignity but necessary due to the risks associated with collection and indispensable for scaling the next generation of allogeneic cell therapies.

Volunteer Vs. Paid Donations

Volunteer blood donation campaigns first began in the U.S. in the 1940s,¹ and paid plasma donations began in the 1960s.² Despite the long history of these practices, paying blood donors is mistakenly viewed as an illegal or unethical practice. In reality, U.S. federal laws allow compensating donors while requiring that any blood component collected for direct transfusion from a compensated donor is labeled with the phrase "paid donor."³ Both volunteer blood donation and paid plasma donation are crucial for saving patients’ lives and improving health. Patients needing direct transfusions of RBCs, plasma, and platelets depend on the kindness of volunteer donors in their communities and nationwide. Patients in need of plasma-derived medicinal products (PDMPs), such as coagulation factors and immunoglobulin, rely on compensated donors across the U.S. and only four other countries worldwide.^2,4 While compensating donors provides significant benefits that enhance the effectiveness and sustainability of the plasma donation system,^5,6,7 the World Health Organization and other health agencies consider voluntary, unpaid blood donation to be the gold standard.^8,9

Below, we explore the main principles employed by the volunteer blood and paid plasma industries — safety, availability, altruism, and ethics — to justify either not paying or paying their donors. Then, based on these same principles, we advocate for the importance of compensating donors generously for cell therapy products to ensure the success of allogeneic cell therapies.

Table 1 is provided as a reference for context on the similarities and differences between factors such as the collection, risks, and motivators of the relevant volunteer and paid blood products.

Table 1: Important Aspects of Different Blood Product Donation Types

* not enough platelets in a whole blood unit for single patient transfusion; RBC = Red Blood Cells; PDMPs = Plasma-derived medicinal products; CFR = Code of Federal Regulations; AABB = Association for the Advancement of Blood and Biotherapies; G-CSF = granulocyte colony stimulating factor

Safety

The blood industry cites safety as a primary reason to collect blood products from volunteer donors only. Financial incentives might encourage individuals with high-risk behaviors, such as IV drug use and prostitution, to donate blood solely for money. This could compromise the blood supply's safety by increasing the risk of transmitting blood-borne infections like HIV, hepatitis, and syphilis. Volunteer models are said to minimize this risk by discouraging donations motivated purely by money.⁹

However, the plasma industry reports that compensating donors leads to a more stable and committed donor base.^7,21,22 Regular compensated donors are more likely to follow guidelines, maintain their health, and avoid high-risk behaviors, resulting in higher quality and safer plasma donations. This consistency is crucial for producing safe and reliable plasma-derived therapies.

The reality is that both unpaid blood donors and paid plasma donors are screened in the same manner, following the same FDA requirements for assessing health and risk behaviors immediately before donation.^10,11 Following donation, the blood or plasma is tested for infections using FDA-mandated tests. In addition, both industries immediately destroy all blood products collected from donors who test positive for infectious disease markers.

Cell therapy product collection centers screen donors differently, often days, weeks, or months ahead in order to qualify a specific donor for a collection. Donors are retested on the day of donation if screening took place more than seven days before.¹⁵ These donors undergo the same FDA-mandated testing as blood and plasma donors¹³ but are required to answer a more thorough screening questionnaire from the Association for the Advancement of Blood and Biotherapies¹⁴ and are often asked to meet additional testing and health requirements from developers.

Overall, manufactured cell therapies have strict requirements for donors and are tested more thoroughly and more often,^15,23,24 making these products the safest on the market for allogeneic use. Due to all the safeguards in place, paying cell therapy donors does not appear to increase the risk of transmitting infections to patients receiving treatments manufactured from their donations. Paying donors can also offset some of the additional costs incurred by donors due to the additional screening steps required.

Availability

Relying on unpaid donors can help maintain a stable and sustainable blood supply. Volunteer donors are said to donate more regularly, ensuring a consistent supply of blood for those in need.⁸ While developed countries have generally kept up their blood supply to meet their transfusion needs, this has recently become more difficult to do across the world.^25,26

The global demand for plasma and plasma-derived products is continually increasing.^4,26 The five countries with paid plasma donation models exceed their plasma needs⁷ and in turn supply 90% of the world's plasma for PDMP manufacturing.^5,6,7 Therefore, all countries depend on paid plasma donors for their PDMP supply, whether or not they have paid or volunteer donor programs in their countries.^7,27

Numerous allogeneic cell therapy products are currently in development, but none have received FDA approval for commercial use. As approvals are gained, developers globally will require a consistent and dependable source of cellular starting material from healthy donors, collected in accordance with good manufacturing practices, to support clinical trials and commercial manufacturing needs. Developers will often qualify specific donors, underscoring the necessity of maintaining a stable, reliable, and sustainable donor population.

Since the paid plasma model is able to meet global demand despite its use in only a small number of countries, it suggests that the best way meet the current and future global demand for cell therapy products is to create a similar model where the donors are motivated to keep themselves healthy and available to frequently donate their cellular material for a fair compensation for their time and risk.

Altruism

Unpaid blood donation fosters a sense of community and altruism. Donors who give blood without expecting anything in return are often driven by a genuine desire to help others. This spirit of volunteerism can inspire others and create a culture of giving within the community.²⁸ This is especially evident during natural disasters, when donors line up outside blood centers to help those in need.

Additionally, adhering to the principle that the human body should not be a source of financial gain, the blood collection community insists that blood donation must be a free and voluntary gesture.²⁹

While some plasma donors are mainly motivated by compensation, many also feel altruistic and satisfied with helping others.³⁰ They understand the crucial role plasma plays in treating people locally and globally and report a sense of satisfaction and community connection. Helping others gives plasma donors a sense of purpose and meaning, alongside the compensation for their time and risk.

The Nuffield Council on Bioethics expresses concern that paying donors for their biological resources could discourage altruistic donations;^29,31 however, more than two decades’ worth of evidence demonstrates that volunteer and paid collection models coexist in the same countries and regions and do not undermine each other.⁷

The Nuffield Council also emphasizes that altruistic motives are key to ethical considerations of biological material donation.^29,31 However, when donors are required to invest substantial time or face significant risks during the donation process, compensation can support their altruistic decisions.

Donating blood, plasma, or cell therapy products requires donors to give three things:

1. A part of themselves: Donors provide a part of themselves, offering life or improved quality of life to others. This gift is invaluable and cannot be compensated for, making altruism always the primary motivator. Those who don't appreciate the value of this gift are unlikely to become regular donors, whether paid or unpaid.
2. Their time: Donors give their time to complete the screening and donation process, sacrificing time they could spend at work, with family, or on hobbies. Compensating donors is a way for collection centers to offset this opportunity cost, potentially enabling more socioeconomic groups to participate.
3. Their trust: Donors trust that collectors will be honest about how their donation will be used, will explain the risks, and will protect them and their personal information. Every blood product donation involves risk, and appropriate compensation can help defray these risks. Ultimately, it's up to the donor to decide if the compensation offered is sufficient for their perception of the risks.

The leukopak collection process is challenging and time-consuming, often taking four or more hours. During this period, donors remain immobile with limited use of their arms and require assistance for basic needs like using the bathroom. Exposure to anticoagulants causes discomfort, ranging from mild unease to severe issues such as cramping and impaired heart or kidney function.¹⁸ Donors of mobilized leukopaks face additional risks from granulocyte colony stimulating factor (G-CSF) exposure, which causes bone pain and enlarges the spleen.¹⁹ Bone marrow donors undergo anesthesia, which carries its own risks.²⁰

Given the significant time commitment and potential risks, cell therapy product donors must be driven by some level of altruism to participate in the donation process. They are right to expect compensation to acknowledge their time and willingness to take these risks. Furthermore, relying solely on altruism in the presence of risk can itself be exploitative.⁶

Even volunteer donations involve some non-altruistic motivations. Being a volunteer blood donor can be a status symbol in local communities. Some individuals donate because of pressure from friends, family, or employers. Others donate for regular health checkups and infectious disease testing. Receiving payment does not negate altruism, and not receiving payment does not confirm it.

Ethics

Ethical debates about paying blood and plasma donors often focus on whether this practice is exploitative.²⁷ Since paying donors could create a market for blood, it has the potential to exploit vulnerable populations and lead to unethical collection and consenting practices.²⁴ Because red cell transfusion is an immediate direct patient intervention, many societies uphold an ethical ideal that the gift must remain untainted by commerce.⁸

In developed countries, most plasma donors are of lower socioeconomic status and therefore potentially more susceptible to financial incentives. This observation alone does not demonstrate wrongdoing; exploitation would require plasma centers to use compensation as a tool to unfairly coerce donors to donate.

As per the FDA, plasma donors must receive full, informed consent prior to each donation. As well, they are informed that their donation will be sold and used to make medicines for profit. While 20% of plasma donors donate only once, 30% donate up to 10 times in six months, and the rest donate more frequently (up to twice per week).⁵ If donors are being coerced into donating, it is unlikely they would keep returning at these rates.

Furthermore, when plasma centers open in new neighborhoods, predatory payday lenders decline and leave the area while local businesses see increased sales.³² Therefore, rather than relying on exploitative high-interest loans, these individuals exercise their agency to choose plasma donation to augment their personal financial situation.

From an industry standpoint, paid plasma donation creates a sustainable, reliable, and ethical supply chain that millions of patients worldwide depend upon. Similarly, the cell therapy industry requires a sustainable and dependable source of starting material to meet its growing needs.

Consent Is Key To Ethical Practices

The Nuffield Council points out that focusing solely on altruistic factors can sometimes mask coercion or exploitation.^25,27 This underscores the importance of a comprehensive consenting process. Donors should be fully informed about the collection process, associated risks, and the intended use of their donated materials, regardless of whether they receive compensation.

It is crucial that the informed consent process includes general information about the destination and potential uses of their entire donation, as well as the benefits received by the collection center. Volunteer blood donors typically understand that their donations will be used for direct patient transfusions, but they also must be told that parts of their donation are sold for use in research and further manufacturing.

Plasma donors are aware that their plasma is collected to be sold for drug manufacturing and of the potential risks and side effects of donating. Similarly, cell therapy donors should be informed during the consenting process of the potential risks and side effects, that their cells will be used for research or drug manufacturing, and that the collector and drug manufacturer will profit from their donation.

Providing comprehensive information ensures an ethical informed consent process. Omitting key details that donors need to make an informed decision about a volunteer or compensated donation constitutes exploitation.

Conclusion

Decades of plasma collection experience have already proved that compensated donation  —  anchored in rigorous screening, longitudinal health monitoring, and transparent consent  —  is not a moral compromise but a public‑health triumph. As first‑in‑class allogeneic cell and gene therapies race toward commercial scale, a reliable supply of healthy donor material will decide whether these cures reach patients or remain scientific curiosities.

The choice before regulators, manufacturers, and advocacy groups is therefore not between altruism and payment; it is between scarcity and access. A donor‑centric compensation model that fairly rewards time and risk, preserves autonomy through robust informed consent, and upholds the strictest safety standards is the only practical path to equitable global availability of tomorrow’s lifesaving medicines.

By aligning policy with real‑world data and donor perspectives, we can build an ethical, resilient supply chain that honors both the generosity of donors and the urgent needs of patients. The future of advanced medicine depends on it  —  and the decisions we make today will determine how many lives we save tomorrow.

References:

1. History Of Blood Transfusions 1628 To Now | Red Cross Blood Services
2. Hemophilia: From Plasma to Recombinant Factors - Hematology.org
3. eCFR : 21 CFR 606.121 -- Container label.
4. Plasma-derived medicinal products: demand and clinical use - PMC
5. Plasma donations: A financial lifesaver and an ethical dilemma | CU Boulder Today | University of Colorado Boulder
6. Consequences of unpaid blood plasma donations | CEPR
7. The case for commercial compensated plasma collections - Niskanen Center
8. Voluntary blood donation: foundation of a safe and sufficient blood supply - Towards 100% Voluntary Blood Donation - NCBI Bookshelf
9. Why Blood Donation Is Unpaid: A Global Perspective — Stanford Blood Center
10. eCFR : 21 CFR 630.10 -- General donor eligibility requirements.
11. Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements; Guidance for Industry
12. Compliance_Program_Guidance_Manual_7342.002
13. eCFR :: 21 CFR Part 1271 -- Human Cells, Tissues, and Cellular and Tissue-Based Products
14. Hematopoietic Progenitor Cell, Apheresis and Marrow Donor History Questionnaire
15. Circular of Information for the Use of Cellular Therapy Products - June 2024
16. Peripheral Blood Stem Cell ​(PBSC) ​Donation Process Overview | NMDP
17. Risk factors for complications in donors at first and repeat whole blood donation: a cohort study with assessment of the impact on donor return - PMC
18. Haemonetics ACD-A SDS
19. G-CSF (Granulocyte-Colony Stimulating Factor) Treatment
20. Bone Marrow Transplant Donor Risks | Moffitt
21. A Deep Dive into US Plasma Donation Statistics
22. Should blood donors be paid? | The Week
23. Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products | FDA
24. Chemistry, Manufacturing, and Control Information for Human Gene Therapy Investigational New Drug Applications; Guidance for Industry
25. Assessing the global burden of hemorrhage: The global blood supply, deficits, and potential solutions - PMC
26. Paying Plasma Centers Proliferate as Volunteer Blood Donors Dwindle
27. Media-Brief-and-Q-and-A.pdf
28. Paying all blood donors might not be worth it
29. Production of plasma-derived medicinal products: ethical implications for blood donation and donors - PMC
30. Debunking common myths about plasma donation: what you need to know - KEDPLASMA WORLD
31. Nuffield Council on Bioethics.
32. Blood Money: The Financial Implications of Plasma Sales for Individuals and Non-Bank Lenders

About The Authors:

Jennifer Chain, Ph.D., CABP, is a cellular therapy expert with 27 years of experience in T-cell immunology, product development, blood banking, and consulting. She holds a Ph.D. in immunology and a Certified Advanced Biotherapies Professional credential from the Association for the Advancement of Blood and Biotherapies (AABB). She currently works as a consultant in the cellular starting material space, helping collection centers and cell therapy companies develop CSM collection and procurement programs and donor screening strategies. Reach her on LinkedIn or CSM Consulting’s website, www.cellsmatter.com.

Stephen McClung, MBA, is an operations and donor‑supply strategist who has overseen more than 540,000 donor collections across plasma, clinical research, and multi‑site biotech operations. A people-centric executive, he couples FDA, GMP, and GCP compliance expertise with hands‑on experience launching and licensing new plasma centers and scaling donor networks. Stephen provides insight on starting and scaling mission-focused businesses and building high-performance teams. Connect with him on LinkedIn.