Blood, blood products and plasma see increased quality and safety requirements

Published: 9-Feb-2016

The use of blood products and plasma is on the rise, and many quality and safety requirements have been introduced to ensure that contaminants are removed. Axel Schroeder, Operations Director, Concept Heidelberg, outlines the main steps to achieve contamination-free products

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For the next few years, experts expect the demand for plasma for fractionation to increase. Human plasma contains proteins that are processed for life-saving medicines – including coagulation factor concentrates – immunoglobulins, albumin and plasma, and is subjected to at least one industrial process, e.g. solvent/detergent plasma.

The supply of this valuable ‘commodity’ essentially depends on two factors: the donor’s willingness to donate and the suitability of the blood/plasma donation. Here, the selection of the donor plays an important role, i.e. the registration of their history and the examination of exclusion factors such as neurological disorders, viral infections (HIV, HBV) or drug abuse.

Donor registration and donor management are the first important steps in ensuring the supply and safety

Donor registration and donor management are thus the first important steps in ensuring the supply and safety. There must also be full traceability in the supply chain: it must be possible to track at any point which donations and from which donor a plasma product has originated from, thus enabling a connection between a plasma donor and the patient who received a specific batch of plasma product(s).

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