The Plasma Journey: What Happens after a Donation is Made?

1. Collection and Freezing

After plasma is donated, a small sample is tested for transmittable diseases like HIV and hepatitis.

After a unit is determined to be safe, it is frozen to preserve its effectiveness – usually within 8 hours after collection. This is known as Fresh Frozen Plasma (FFP), which has a shelf life of about a year.

Some FFP is sent directly to hospitals and other healthcare facilities to be used as a clotting factor to treat bleeding associated with a raised Prothrombin Time (PT) or Partial Thromboplastin Time (PPT).

It is also used in conjunction with prothrombin complex concentrate to treat warfarin excess when there is clinically significant bleeding or a high risk for it.

2. Holding for Final Testing

Most plasma units that have passed initial testing are transported to a warehouse, where they are held for a minimum of 60 days to confirm the donor’s health and the safety of the plasma.

After final checks and testing, plasma donations are sent to production facilities in the U.S. and around the world.

Some plasma is sent to medical research companies, who use it to develop new treatments, diagnostic tests and therapies for various diseases and conditions.

3. Pooling, Fractionation, Purification and Formulation

Plasma from multiple donors is POOLED together to standardize the composition of the plasma and ensure consistent levels of the desired proteins or antibodies.

Then, plasma undergoes a process called FRACTIONATION, where it is separated into individual components based on their molecular weight and properties. This allows for the isolation of specific proteins or antibodies for pharmaceutical use.

Isolated proteins or antibodies are further PURIFIED to remove any contaminants, ensuring the final plasma-derived medicine is safe and effective for patients.

The final manufacturing step is the FORMULATION of the proteins and antibodies into products, which may include intravenous injections, subcutaneous injections, or other dosage forms, depending on the intended use.

Throughout the manufacturing process, starting with donation at a plasma center, rigorous quality control measures are implemented to monitor the purity, potency and safety of the pharmaceutical products.

These include:

• Testing for contaminants
• Stability testing
• Ensuring compliance with regulatory standards

The global supply of plasma is dominated by the U.S., with the majority of this plasma coming from the U.S. commercial plasma industry.

4. Saving Lives

Drug manufacturers sell finished products to hospitals and other medical facilities.

Plasma-based products are used for:

• Preventing hemolytic disease of the newborn (for Rh-negative mothers)
• Immunizations against hepatitis A, measles and polio
• Treating people with shock due to blood loss
• Treating some primary immune deficiency disorders
• Peventing blood clots during surgery or childbirth
• Treating patients with hemophilia B
• Treating people with chronic inflammatory demyelinating polyneuropathy (CIDP)

Therapies created using the proteins in plasma restore healthy proteins and treat people with bleeding, clotting, lung, autoimmune, genetic, and other conditions, such as:

• Alpha-1 antitrypsin deficiency
• Von Willebrand disease
• Antithrombin III deficiency
• Kawasaki disease
• Hereditary angioedema
• Idiopathic thrombocytopenic purpura
• Diseases of the nervous system, such as polyneuropathies and myasthenia gravis

Source plasma is also used for:

• Tetanus, rabies and whooping cough treatments
• Burn treatments
• Organ transplants

It takes a lot of plasma to keep America healthy.

• Treating one hemophilia patient for a year takes 1,200 plasma donations.
• Treating one patient with alpha-1 antitrypsin deficiency for a year takes 900 plasma donations.
• Treating one patient with a primary immune deficiency for a year takes 130 plasma donations.

Over 125,000 patients benefit from plasma donations each year in the United States alone. Suffice it to say, a plasma donor has helped someone close to you!

That’s why every part of the plasma supply chain, from the collection site to the facility delivering a plasma-derived medication, is important.

PLASMA PASSES THROUGH MANY HANDS FROM ITS JOURNEY FROM THE DONOR’S TO THE RECIPIENT’S ARM. EVERY STEP IN THE JOURNEY IS IMPORTANT, AND IT TAKES THE WHOLE INDUSTRY ADHERING TO STRICT MANUFACTURING GUIDELINES TO MAKE THE PROCESS WORK SAFELY AND EFFICIENTLY.