Plasma for medicine
The Irish Blood Transfusion Service’s (IBTS) Medical and Scientific Director, Andrew Godfrey and Director of Production and Hospital Services, Barry Doyle talk to eolas Magazine about the future of plasma derived medicines in Ireland and the organisation’s vision for plasma collection, and the successful delivery of a strategic initiative – the reintroduction of Irish plasma for therapeutic use.
Remember ‘mad-cow disease’? In 2001, the IBTS decided to import plasma from areas free from Bovine Spongiform Encephalopathy (BSE) to reduce the risk of transmission of variant Creutzfeldt-Jakob disease (vCJD), the human form of BSE. This was part of several precautionary steps taken, when the possibility of transmission of vCJD by blood transfusion first emerged. After over two decades of importing plasma from abroad, the Irish Blood Transfusion Service are now producing bulk plasma for human therapeutic use again.
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 per cent of your blood. It contains clotting factors that help to stop bleeding, and antibodies, known as immunoglobulins, which fight infection.
Plasma can be transfused as liquid plasma, processed into other plasma products, such as cryopreciptate or used as a source of important medicinal products known as plasma derived medicinal products (PDMPs). These are therapeutic agents essential to life-saving healthcare, which are obtained by a combination of large-scale processing steps called fractionation.
“In addition to the the importation of plasma for therapeutic use there was also an embargo on the collection and use of Irish donor plasma for fractionation into PDMPs. However, time has moved on and the risk of vCJD has been carefully re-assessed and the IBTS are now processing plasma for fractionation again to make essential medicines,” says Godfrey.
The fractionation processes used by plasma manufacturers are highly complex and specialised, and result in the separation of individual protein components of plasma, which are purified and subjected to pathogen inactivation. These products are used for the treatment of a variety of conditions including immune disorders, neurological disorders, blood disorders and infectious diseases.
One of the products most needed by patients is immunoglobulin which is used to reduce the effects of some inflammatory diseases, boost immunity and help fight infections in some immune-compromised patients. As well as immunoglobulins, plasma also contains a protein called albumin, which is used to treat people with liver disease, kidney failure, and major burns.
There is a significant deficit in the volume of plasma currently being collected in Europe and there is a drive to achieve self-sufficiency for PDMP production. Until recently, Ireland did not contribute to the plasma supply in Europe to make PDMPs.
Europe is heavily reliant on the United States and the EU is seeking greater security and control of its plasma collection and PDMP availability. Optimising the plasma collection supply chain is essential to removing the vulnerability and reliance on outside sources of PDMPs.
Optimising the plasma collection supply chain is essential to removing the vulnerability and reliance on outside sources of PDMPs.
During routine processing of blood, the red cells are separated from the plasma. Previously in Ireland this plasma was discarded or used in the manufacture of laboratory reagents. Now this plasma, known as recovered plasma, will undergo controlled freezing, storage and shipping to a manufacturer to make medicinal products.
Medicinal plasma will be returned for use in Irish hospitals and any plasma that is surplus to the requirements of the Irish healthcare system will be used in the manufacture of other medicinal products such as immunoglobulin. This ensures that we make best use of every donation for patients in Ireland as well as contributing to the European pool of plasma.
The IBTS will enter its final year of its strategy ‘Connections that Count’ in 2025 and the re-introduction of plasma for therapeutic use is a key strategic initiative delivered under this current strategy. “It was a significant undertaking encompassing all aspects of the organisation from donation clinic to plasma distribution,” according to Doyle.
Manufacturing experience and engineering skills were utilised to supplement existing technical and clinical expertise. “The project entailed infrastructure changes in the blood processing area in the National Blood Centre, the implementation of industrial freezing technology and a suite of electronic system changes to enable the management of plasma product and data. The IBTS has now introduced plasma handling, freezing and storage processes compliant with industry regulations for medicinal products and the first shipment of plasma for fractionation took place in December 2024,” Doyle adds.
What is the future for plasma medicines?
There is an ever increasing demand for PDMPs estimated to increase 6 per cent year on year, and the recovered plasma shipped for fractionation will only partly meet the healthcare needs for PDMPs, especially immunoglobulin.
The indications for PDMPs are continuously expanding, as is the portfolio of medications which can be derived from source plasma. Many patients are completely reliant on regular infusions of PDMPs, but currently Europe can only meet around 60 per cent of its overall need for PDMPs and for some products the proportion is much lower.
To ensure we can meet the future needs of patients in Ireland, and become fully self-sufficient, additional plasma must be collected directly from donors in a process called plasmapheresis. This is where blood is removed from the donor, plasma is separated and the red cells returned to the donor. This is known as source plasma and the IBTS is well placed to commence this as we already collect platelet donations in a similar way.
Plasma donors can safely donate a larger volume at each visit and much more frequently than whole blood donors and so are key to meeting this gap.
Most European countries collect source plasma to supplement the plasma supply. Following the removal of restrictions relating to vCJD, source plasma collection is now possible in Ireland and the IBTS are in the early stages of scoping what this strategic development might look like.
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