What is plasma and why is it so important?
Blood is a mixture of cells (e.g. red cells, platelets, white cells) suspended in plasma. The plasma portion is about 50% of the total blood volume and contains a wide range of proteins essential to life. These proteins can be separated and purified to produce a range of stable injectable products for treatment of various diseases and trauma. These products are often lifesaving and many are included in the WHO Model List of Essential Medicines.
Examples of diseases treated with Plasma Derived Medicinal Products (PDMPs).
Please click here to access the article on “Plasma” as published in Transfusion Today in September 2017.
Source Plasma is the liquid portion of human blood collected by a procedure known as plasmapheresis. In this procedure the donor’s blood is processed through an apheresis machine, which extracts only the plasma and returns the cellular components (red cells, platelets etc) to the donor. The use of this technique permits more frequent donation than whole blood donation without harm to the donor. The plasma collected is frozen within 2 hours and may be used for individual transfusion or as a raw material for further large-scale manufacture into Plasma Derived Medicinal Products (PDMPs).
Recovered plasma is the liquid portion of anti-coagulated whole blood donations remaining after separation of the cellular components.
IPFA Donor Information Standard
The IPFA Donor Information Standard defines the ethical and guiding principles to maintain and enhance the quality of donor information of its member organisations involved in the collection of human blood and plasma for fractionation. It focuses on educating and informing donors on the destination of their voluntary recovered plasma and source plasmapheresis donations and their use for further processing via fractionation into PDMPs.
The purpose of this standard is to establish minimum requirements for education and information provided to donors to:
- Improve donor knowledge and insight into the full extent of the use of their donation
- Promote transparency to ensure sufficient information is provided to the donor to make an informed decision made with full knowledge.
Each IPFA blood or plasma center Member may provide the information in any format of their choice, in developing or adapting their electronic, paper or video-based donor information and education system (or materials) based on these standards to provide relevant and appropriate information to donors, as long as it contains the main messages and criteria and fulfills the objectives.
Quality of Plasma
Plasma must be of high quality for subsequent manufacture into PDMPs.
Blood/plasma donor selection, collection procedures, testing methods, donation handling, storage and transport of plasma should follow defined quality assurance procedures, the importance of which has been highlighted by international guidelines.
Security of Supply
Strategy for secure and sustainable plasma supply
There is a sustained increase in the global demand for Plasma Derived Medicinal Products and this is likely to continue for the foreseeable future. The raw material plasma supply to meet this need is predominantly from the US where 5% of the global population provides approximately 70% of the global plasma supply. IPFA advocates a more diversified global plasma supply to minimize the risks of product shortage resulting from US plasma supply interruption or failure. IPFA calls for National and Regional policies and strategies to promote increased plasma collection and reduction of recovered plasma wastage in other regions of the world. PDMP access and supply shortages are a critical safety factor for patients.
Please click here to access the paper “Plasma is a strategic resource” published in Transfusion 2016;56;3133-3137.