Plasma Collection Industry: Lessons Learned from a Paid Donor System

Plasma Collection Industry: Lessons Learned from a Paid Donor System

Blood plasma fractionation is a biopharmaceutical manufacturing process in which plasma components are isolated and processed into therapeutic products for clinical use. These therapeutics are used for the prevention and treatment of rare and often chronic conditions including infectious & autoimmune diseases, shock, trauma, hemophilia, and other life-threatening situations. This post discusses how the plasma industry efficiently meets burgeoning demand for plasma components through the responsible use of a paid donor blood collection strategy.

Plasma Fractionation Explained

Blood is composed of four basic components: red blood cells, white blood cells, platelets, and plasma. During the plasma fractionation process, the cellular elements are removed from the blood while specific protein constituents are retained.  The outputs of this manufacturing process are so-called “plasma derived products.” Unlike blood donors in the not-for-profit system, plasma donors are compensated for their time. These compensated plasma donors undergo similar health and history screenings and infectious disease testing as non-profit system donors. 

The Plasma Industry Sources its key Raw Material from Compensated Donors

Plasma derived products such as Factor VIII, Factor IX, albumin, and immunoglobulins are commonly used in patient care at major hospital institutions. Manufacturing these products requires millions of liters of plasma to be collected annually to meet the world-wide demand for plasma derived products. Data from the Plasma Protein Therapeutics Association (PPTA) has revealed a steady increase in plasma collections from 10 million liters in 2005 to almost 40 million in 2016, while the number of plasma collection centers increased from 300 in 2005 to 700 in 2018. Through the use of a safe and efficient paid donor system, plasma collection centers can continuously recruit sufficient donors and scale operations to meet the rapidly increasing global demand for plasma derived products. 

Compensated Plasma Donors are Younger Than Typical Blood Donors

In a previous post, we highlighted that the blood supply is fundamentally challenged due to the aging of the largest cohort of volunteer donors (peak age of 41-45 in 2001 to peak age of 56-60 in 2017). In the compensated donor model for plasma, however, the PPTA published 2012 data showing that the majority of plasma collections came from donors <35 years old (Fig 1). This data indicates that a remunerated model effectively mobilizes an otherwise non-participatory group of blood donors.  

 Figure 1. Generational gap of volunteer versus paid blood donors

The Bottom Line: Blood Donors can be Compensated for Their Time Without Sacrificing Safety

In a recent blog post, we discussed the history of compensated and non-compensated blood donation in the United States, with a particular emphasis on the impact of key technological breakthroughs (the 2002 and 2014 FDA approval of nucleic acid testing and pathogen reduction for transfusable components, respectively). We also discussed the advent of the source plasma industry donor “pedigreeing” process whereby no plasma components from a particular donor are released unless an individual clears two separate infectious disease screening tests. With advances in testing technology, the finely tuned donor selection process for the source plasma industry, and the 100% use of pathogen reduction, the use of compensated donation has the potential to create new standards in safety and component availability.  

Secure Transfusion Services (STS) is a specialty blood collection organization focused on supplying hospitals with hard to source transfusable components using the source plasma industry model of responsibly recruiting donors compensated for their time. The initial screening for STS donors differs from that of the current volunteer model.  First-time donors have no transfusable product collected. Instead, donors at their first visit to an STS facility undergo health, history, and infectious disease screening in accordance with AABB standards. Components are collected from donors on a second appointment, where the collected units are used only if both the initial and subsequent infectious disease screening tests are negative. Further, STS employs 100% use of pathogen reduction allowing its customers to be fully compliant with the FDA’s Bacterial Risk Control Strategies for Blood Collection.

References

TRANSFUSION Volume 58, Issue S2: Abstract Presentations from the AABB Annual Meeting, Boston MA, October 13-16, 2018. 

Schreiber GB, Kimber MC. Source plasma donors: a snapshot. Transfusion 2017; 57 (S3): 110A.

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Federal mandates may constrain platelet availability even more4,9

The safety of platelet transfusions is critical, and recent US Food and Drug Administration (FDA) mandates on bacterial risk mitigation require platelet collections to undergo proactive safety protocols, such as large volume delayed sampling or pathogen reduction. Platelet volume loss due to methods such as these may further erode the platelet supply.4,9