What is Plasma

What is plasma and how does it benefit patients?

Plasma is the liquid part of your blood that carries red cells, platelets and white blood cells around the body. It makes up approximately 55% of your blood. It contains clotting factors that help to stop bleeding, and antibodies, known as immunoglobulins (IVIGs), which fight infections.

What is changing about how my donation is used?

A whole blood donation is made up of a number of components that can be used to treat patients.  Red cells, platelets and plasma are the main components of each whole blood donation.  For many years the IBTS were unable to use the plasma component for treating patients because of the concern that it could transmit vCJD (variant Creutzfeldt Jacob Disease).  This is no longer a concern and starting in the autumn of 2024 the IBTS will send Irish plasma from whole blood donations to a plasma fractionator in Europe to make products that can be transfused to patients in Ireland and Europe. These products include pooled plasma and other Plasma Derived Medicinal Products (PDMPs).

What will happen to the plasma component of my whole blood donation?

During processing of your blood donation, the red cells are separated from the plasma. Previously this plasma was used in the manufacture of laboratory reagents, tests and controls and was not used for treating patients. Now this plasma will be sent to a manufacturer to make a therapeutic product called LG-Octaplas. This product will be sent back to the IBTS from the manufacturer for use by the Irish healthcare system. It is used to help blood to clot and to stop bleeding. It is essential for the effective treatment of major blood loss, which could be caused by a road traffic accident or complications of childbirth. It is also used to treat some rare congenital coagulation factor deficiencies and to support patients with acquired causes of low levels of clotting factors such as those with liver disease, sepsis or disseminated intravascular coagulation (DIC).

Any plasma that is surplus to our requirements for LG-Octaplas will be used in the manufacture of plasma derived medicinal products (PDMPs) in a process called fractionation.

PDMPs include a wide range of products but the most important are those which support patients with disorders of the immune system and those with congenital clotting factor deficiencies. Without these products, we would be unable to manage these medical conditions effectively.

PDMPs are critical medicines and are subject to pharmaceutical regulation. In Europe, virtually all PDMPs are manufactured in partnership with commercial fractionators, where Blood Establishments collect the plasma and fractionators process it and manufacture the medicines. 

Plasma fractionation is a large-scale pharmaceutical manufacturing operation and for that reason PDMPs are manufactured in the commercial sector where there are profit margins applied to the final product, as with any other medicinal product.

There is insufficient plasma collected in Ireland to make fractionation feasible by the IBTS. Patients would not have essential PDMPs available to them without the commercial fractionation industry.

The IBTS is committed to voluntary non-remunerated donations for a safe, sustainable blood supply. The IBTS adheres to the European Directorate for the Quality of Medicines and Healthcare (EDQM) standards, which prohibits the collection of donations for financial compensation within member organisations. This is affirmed in the new Substance of Human Origin Regulation (SoHO) and aligns with the European Blood Alliance position that donation should be voluntary and non-renumerated in order to ensure the safety of both donors and recipients.

What are Plasma Derived Medicinal Products?

These are life saving medicines that are made from pooling plasma and extracting out specific plasma components or proteins. These products are used for the treatment of a wide variety of conditions including people with immune disorders, neurological disorders, blood disorders and infectious diseases. One of the products most needed by patients is a product called immunoglobulin or IVIG which is used to reduce the effects of some inflammatory diseases, and also to boost immunity and help fight infections in some immunocompromised patients.

As well as immunoglobulins, plasma also contains a protein called albumin, which can be used to treat people with liver disease, kidney failure and major burns.

Why does my plasma have to be sent abroad to make this product?

The processes used by manufacturers of plasma are highly complex and specialised. This is known as plasma fractionation. The manufacturers who specialise in making this and other plasma derived products have many years of experience and are world leaders in their field. There are no plasma fractionators with manufacturing processes based in Ireland.

Why are you asking the UK residency question again?

Plasma is pooled to make medicinal products and the rules relating to this are slightly different to whole blood. There is still a deferral in place relating to vCJD and plasma, even though you can donate whole blood and the red cells can still be used for transfusion. The rules around plasma are changing in Europe, however they haven’t changed fully yet. We will be able to remove the UK residency question again in the future in relation to plasma.

Besides the plasma, is there anything else you are sending abroad to this manufacturer?

The IBTS will be sending certain information regarding your donation to the manufacturer.  This is for safety reasons and to ensure full traceability of the product.  Further information regarding your donation data is available at this link.

What happens if I don’t want my data or my plasma sent abroad?

If you do not consent to your plasma and/or your relevant donor data being sent abroad to make LG-Octaplas or PDMPs then you will not be able to proceed with your donation.