Plasma faqs

What is plasma?
Plasma is a clear, yellowish liquid component of human blood that is generally 50-60 percent of the volume. Cells and a variety of substances vital to the human body are carried throughout the body in plasma. It contains water, salts, enzymes, antibodies, and other proteins. The substances carried in plasma are critical to fighting diseases, and therefore,essential for maintaining health.

What are plasma proteins?
Plasma contains numerous proteins which are required for the body to function properly. Important plasma proteins include:
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• Albumin which maintains fluid balance by keeping fluid in blood vessels and transports substances like hormones, vitamins, fatty acids, and drugs throughout the body)
• Alpha-1 Proteinase Inhibitor​ (protects the lungs)
• C1 Esterase Inhibitor​ (helps regulate inflammation)
• Clotting or Coagulation Factors​ (control bleeding)
• Fibrinogen (controls bleeding and helps wounds heal)
• Immunoglobulins or "Antibodies"​ (control the immune system and prevent illness)
• And many more! The body has thousands of plasma proteins, many of which are being researched for additional treatment purposes.
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What are plasma-derived medicines?
Plasma-derived medicines (also often referred to as plasma protein therapies or plasma-derived medicinal products [PDMPs]) are medicines made from donated plasma. These therapies are used to treat people with rare, chronic, and life-threatening conditions. Examples are treatment of shock and burns, inability to fight infection, inability to form a clot to stop bleeding. Manufacturing plasma-derived medicines is a lengthy, complex, and highly regulated process which can take up to one year.

What conditions do plasma–derived medicines treat?
These unique therapies treat a variety of chronic and life-threatening medical conditions, many times caused by insufficient levels of any one plasma protein. Medicines created from donated plasma are sometimes used as a sole treatment or in combination with other treatments to support a variety of medical needs. Some conditions include:
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• Alpha-1 Antitrypsin Deficiency – a genetic condition that can cause damage to the liver and lungs.
• Hereditary Angioedema – can lead to severe swelling and be fatal if airway is obstructed.
• Bleeding Disorders – patients cannot regulate bleeding; can be fatal if bleeding occurs in brain or vital organs.
• Immunodeficiency Diseases – causes patients to become chronically ill from severe, persistent, recurrent infections.
• Chronic Inflammatory Demyelinating Polyneuropathy – symptoms include progressive weakness, loss of limb function, and disability.      
• Hemolytic Disease of the Newborn (HDN) – when a mother is Rh-negative and the baby is Rh-positive, the mother’s immune system becomes sensitized and makes antibodies against the baby’s red blood cells. However, when the mother receives anti-D immunoglobulin, it protects the baby from life-threatening blood destruction caused by Rh incompatibility.
• Everyday Medicines – plasma-derived medicines are used to treat shock, severe burns, and massive blood loss and can help stabilize patients in intensive care units. Plasma-derived medicines are used in hospitals every day to control bleeding and manage infections in transplant patients.
  

Why are plasma-derived medicines so critical?
Plasma-derived medicines are critical because they replace or supplement essential human proteins that the body cannot make on its own — or cannot make in sufficient amounts — when people are sick, injured, or genetically unable to do so. For many patients, there is no alternative therapy.

How are plasma-derived medicines made?
The production of plasma protein therapies begins with donated plasma from healthy individuals. Plasma donations are pooled, and then individual proteins are extracted through a complex and highly-regulated process called fractionation.

How is plasma collected?
Unlike simple blood donation, plasma is collected through a process called plasmapheresis. A needle is placed into a vein in the arm and connected to a plasmapheresis machine which removes whole blood, separates the plasma from the other blood components, and then returns those components to the donor.

What is source plasma?
Source plasma is plasma collected from healthy donors and used exclusively to make plasma protein therapies. The U.S. FDA defines source plasma as the fluid portion of human blood collected by plasmapheresis and intended as source material for further manufacturing use. The definition  distinguishes source plasma from transfused components like red blood cells. (Source)

What is recovered plasma?
Recovered plasma is plasma that is taken from a whole blood donation, rather than collected from a plasma donor through plasmapheresis. Recovered plasma, when not needed for transfusion or other purposes, is sometimes used to make plasma-derived medicines.

Are plasma donors paid/compensated?
People are compensated for their commitment and effort as donating plasma can be a lengthy process, and one that typically involves frequent donation. Plasma donation is not a one-time solution. Patients rely on consistent access to therapies year-round, meaning the need for plasma is constant. Because plasma-derived medicines take between 7 to 12 months to produce from donation to availability for patients and require multiple donations to create a single treatment, maintaining a stable plasma supply with the commitment of healthy, regular donors are critical to meeting patient need. For example, it takes approximately 1,200 plasma donations to treat one person living with hemophilia for one year.

Donating plasma saves and supports millions of patients' lives around the world and is   critical for therapy for many patients. Much like the gift cards and other tokens that blood donors receive, plasma donors are provided with a modest stipend to recognize the substantial commitment of personal time and travel required to be a plasma donor. Each plasma collection facility sets its own compensation rates. Contact your local plasma collection center to discuss their specific compensation policies.

What is PPTA?
PPTA is the advocacy and standards setting organization for the plasma protein therapeutics industry. PPTA works to ensure reliable, sustainable access to plasma-derived medicines and advocates for strong regulatory frameworks; develops and promotes quality standards; and fosters continuous innovation – always centered on the wellbeing of patients and donors.

Does PPTA work with patient groups?
Yes, PPTA partners with patient groups as part of its advocacy and stakeholder engagement efforts as collaboration with patient advocacy groups is one of PPTA's core activities. These collaborations are part of PPTA's mission to improve access to plasma-derived medicines and to support patients who depend on these medicines for rare or common serious conditions. PPTA  advocates for access to therapies for patients, often aligning with patient groups on public policy, regulatory issues, and access challenges affecting patients who rely on plasma-derived protein therapies. PPTA supports patient organizations and raises global awareness of rare diseases treated with plasma-derived medicines, as well as educates the public about plasma donation and the importance of patient access around the world.
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Is donating plasma safe?
Donating plasma is a very safe process that is highly regulated. To ensure the plasma donor safety and ensure uniform, high-quality standards for collection practices, PPTA developed the International Quality Plasma Program (IQPP), which is a global quality and safety standards program. The IQPP requirements often go beyond national regulations and ensures plasma collected around the world meets the same high standards.
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Plasma collection centers follow strict donor eligibility, monitoring, and safety standards, including trained staff, medical oversight, and post-donation care. Plasma donation is similar to blood donation in several important ways, especially when it comes to donor safety, screening, and the types of experiences donors may have. Plasma donation adverse events are generally similar to those seen in whole blood donation, and most are mild, temporary, and manageable.
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What is the purpose of IQPP?
The International Quality Plasma Program (IQPP) protects donors and patients by focusing on donor health while ensuring plasma quality for patients who rely on plasma-derived medicines. IQPP is a rigorous, voluntary program that goes beyond regulatory requirements to help ensure donor safety and further improve the quality of source plasma used for fractionation.
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How often can you donate?
While Plasma regenerates quickly in the body and red blood cells are returned to the donor during donation, donation frequency is set to protect the long-term health of the donor. The frequency of plasma donations is regulated by national health authorities. Before each donation, donors must meet eligibility requirements, pass health screenings, and have adequate protein levels.

Can I donate at multiple centers?
Yes, as long as you do not donate more frequently than allowed by regulators and reside within the Donor Recruitment Area (DRA) of all centers. PPTA’s Donor Safety Standard only allows donors who permanently reside within the defined DRA of the plasma center to donate at that center. The standard helps to maintain a steady and reliable donor population and supply of quality plasma.  
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How are donor registries used?
Two systems developed by PPTA, the Cross-Donation Management System (CDCS) and National Donor Deferral Registry (NDDR), are key industry-developed measures to further protect donor and patient health. Because donors may visit different collection centers, these systems enable uniform, industry-wide safety checks. Each donor is checked against the CDCS at every donation, ensuring that donors do not donate more frequently than allowed. The CDCS only holds data for 7 days and is used only for safety and eligibility purposes, not marketing or compensation decisions. The NDDR, which also operates under strict privacy and data-protection requirements, contains limited information about donors who have received reactive test results for HIV, HCV or HBV, permanently deferring them from donation, no matter where they donate.
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Can anyone donate plasma?
Plasma donation requirements are designed to protect donor health and ensure patient safety. While details can vary slightly by country and collection center, the core requirements are similar worldwide. Donors are considered eligible to donate plasma after completing a successful pre-donation health assessment which includes a brief physical examination and answering medical history questions. Protein and hemoglobin levels are evaluated before each donation. Contact your local plasma donation center to learn more about the eligibility process.

Are there restrictions to donating plasma?
Plasma donation requirements are strict but straightforward, with a strong focus on donor safety, monitoring, and long-term health — similar to blood donation, with additional checks related to plasma proteins. In the US, donors must be 18 years of age or older and weigh 110 pounds or more. Donors must be in good general health, and feel well on the day of donation, with no fever or active illness. To determine if you are eligible to donate, please contact your local donation center.

Are plasma-derived medicines safe?
The production of plasma-derived medicines is strictly regulated by competent authorities, but the industry’s dedication goes even further. Additional safety measures and standards are implemented to protect donors and ensure their well-being. Every plasma donation undergoes rigorous testing for quality and safety. Advances in testing technologies help ensure plasma safety while meeting regulatory standards efficiently. Plasma from thousands of donations is pooled to achieve the large-scale volumes needed for manufacturing. This step ensures consistency in the final product, reflecting the global collaboration required to meet clinical need.

Using specialized techniques, the pooled plasma is separated and purified, and each protein undergoes advanced processes to ensure therapeutic safety. Innovations in purification techniques continue to enhance efficiency, ensuring these lifesaving medicines meet the highest safety and quality standards. Multiple safety protocols, including heat treatment, nanofiltration, and solvent/detergent treatment, are employed to inactivate or remove viruses. These measures safeguard against known and emerging pathogens, supporting the trust and reliability of plasma-derived medicines worldwide. Purified proteins are formulated into therapies like intravenous immunoglobulin (IVIG) or clotting factor concentrates and filled into sterile vials or other methods of administration. Continuous engagement with regulatory bodies helps assure efficient and safe approval processes, ensuring timely access for patients.

Where is plasma collected?
Source plasma is collected at specialized donation centers located in the United States and Europe. To find a center near you, visit here.
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How many plasma donation centers are there in the United States?
There are more than 1,000 IQPP certified plasma donation centers in the United States. To find a center near you, visit here.
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How many plasma donation centers are there in Europe?
PPTA members collect plasma in more than 150 donation centers in Europe. To find a center near you, visit here.

How much plasma is collected in the United States?
Each year, millions of plasma donations are made across the United States at IQPP certified centers.
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How much plasma is collected in Europe?
Each year, millions of plasma donations are made across Europe at IQPP certified centers.

What is the availability of plasma-derived medicines in the United States?
Information about the aggregated distribution of plasma protein therapies in the U.S. is provided through PPTA’s North America Distribution Data Program, available here.
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How do collection centers impact local economies?
Plasma donation centers support local economies through the creation of jobs, taxes, and donor compensation. Each plasma donation center employs dozens of skilled staff.