Understanding the plasma ecosystem from donor to patient

12/05/2023

One reason people do not consider donating plasma is that they do not understand the process. Some questions folks have include how their plasma is collected and what happens to it after it is collected. Additional mysteries to a potential donor include who exactly their donation will benefit, and for what purpose. Here’s what donating plasma looks like and how donations are turned into medications, as well as who receives these medications. 

Donating plasma

One way to collect plasma is from whole-blood donations through centrifugation. This is routinely done by organizations such as the Red Cross. This process is called “recovered plasma,” as the goal of the collection initially is to obtain red blood cells and platelets, making plasma a by-product as it gets separated out. However, the process does not yield nearly enough to supply the need for plasma nationally or globally. 

Source plasma from dedicated plasma collection centers is where the main supply of plasma comes from in the United States. When a donor arrives at a plasma center, they go through an individual health assessment to ensure it is safe for them to donate and that their plasma is safe to be used by patients. The plasma is collected through a process called plasmapheresis, where whole blood is extracted from the vein in one of the donor’s arms and returned to the other arm with all components remaining other than the plasma. This process takes about one hour. A donor's body regenerates the lost plasma over the next 48 hours. Regulations on this procedure have been standardized across the United States by the Food and Drug Administration (FDA) with support from the Red Cross, allowing donors to be sure it is done safely.

Manufacturing plasma-derived medicinal products (PDMPS) 

Once the plasma is collected, it undergoes a series of tests for contamination prevention, and techniques are used for virus inactivation to ensure it is safe for use. One of those universal tests is a nucleic acid amplification test (NAT), which is conducted in a laboratory to identify any HIV or hepatitis C virus (HVC)-infected donations, which are then removed from the process. Above and beyond testing, pathogen inactivation and/or removal is required post fractionation during the manufacturing stage to ensure prevention of transmission of infection agents This process can take 7-12 months for a donation between donation and final product release.

Many of the companies that collect plasma at their plasma centers are the same companies that manufacture PDMPs through a process that begins with fractionation. Fractionation is where individual proteins are separated out to be used for the specific needs of patients who require them. As the demand for each protein is met throughout the year, such as cryoprecipitate, a protein that contains coagulation factors, companies begin to pair down the level to which they fractionate their supply of plasma. Typically, IgG and Albumin are left as the “last liter” products that they manufacture from every single donation of plasma. 

How a patient receives these therapies

For many plasma-derived products, the annual cost for a patient can be upwards of $200,000. That is because it can take upward of 1,200 donations to treat one patient with hemophilia for one year, for example. It is roughly estimated that 50% of the cost of these therapies comes from collection of the raw material alone, for example, through compensating donors and operating plasma centers. Over 125,000 people in the United States rely on PDMPs for various lifelong conditions, and the number is much higher for those who require plasma for short-term needs, such as trauma and burns. 

When an individual and their healthcare provider make a decision about beginning plasma-derived treatments, there are many options in front of them. Human albumin solution (albumin), polyvalent immunoglobulin for intravenous administration (IVIG), factor VIII concentrates (FVIII), factor IX concentrates (FIX), prothrombin complex concentrates (PCCs) and antithrombin (AT), to name a few. Some are administered at a facility-type setting, often on a monthly basis, and some are able to be administered at home. The latter can be done on a patient's own schedule but typically must be administered more frequently. The increase in frequency also aids in keeping a steady supply of the product in their system rather than the peak and pits of a monthly regiment. 

The need for therapeutic plasma proteins is anticipated to continue to grow in the years to come. To avoid the dangers of an undersupply of these critical medical substances, consider joining the thousands of heroes who donate today.

News & Updates

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