Proceedings of the Tenth International Conference of Drug Regulatory Authorities (ICDRA) - Hong Kong, China, 24 - 27 June 2002
(2002; 166 pages) View the PDF document
Table of Contents
View the documentAbbreviations and acronyms used in this report
Open this folder and view contentsOpening ceremony
Open this folder and view contentsHerbal medicines
Open this folder and view contentsKeynote address
Close this folderSafety of blood-derived products
View the documentQuality and safety of plasma for fractionation
View the documentProcedures for inactivation and removal of viruses
View the documentGMP in blood plasma collection centres
View the documentPlasma fractionation - Brazilian programme of self-sufficiency in blood products
View the documentSafety of blood products in New Zealand
View the documentRegulatory experience in Argentina
View the documentSafety of blood products in the Islamic Republic of Iran
View the documentRecommendations
Open this folder and view contentsAntimicrobial resistance - new initiatives
Open this folder and view contentsHarmonization I
Open this folder and view contentsHarmonization II
Open this folder and view contentsProtection of trial subjects in clinical trials
Open this folder and view contentsRegulating biotechnology products
Open this folder and view contentsRegulatory challenges: health sector reform and drug regulatory capacity
Open this folder and view contentsAccess to drugs and vaccines I
Open this folder and view contentsAccess to drugs and vaccines II
Open this folder and view contentsCounterfeit pharmaceutical products
Open this folder and view contentsHomoeopathy
Open this folder and view contentsSafety monitoring
Open this folder and view contentsE-Commerce
Open this folder and view contentsCurrent topics
Open this folder and view contentsRegulatory challenges of new technologies
View the documentList of participants
View the documentBack cover
 

Quality and safety of plasma for fractionation

Dr Albert Farrugia, Australia

Plasma may be procured for use as a therapeutic product or as a raw material for manufacture of other products, and may be collected as a by-product of whole blood, or as a plasma donation from apheresis. When collected for fractionation, the quality and safety of the plasma are intimately linked to the quality and safety of the manufactured plasma derivatives.

High quality plasma can be obtained either from whole blood or from plasmapheresis; quality can, however, be adversely affected by poor storage conditions after collection. Quality standards for plasma for fractionation are necessarily different than for plasma for transfusion and, with modern fractionation methods, certain quality aspects become less relevant.

Very often a three-pronged approach is used to ensure the safety of biological products:

• selection of appropriate raw materials (donors and cell lines);
• testing of raw materials (screening and viral tests); and
• appropriate action during processing (viral inactivation and product integrity).


Recent technological advances, such as nucleic acid testing (NAT), are used for testing plasma pools for fractionation. However, although this decreases the load of known viruses, viral inactivation procedures are more important in ensuring the viral safety of plasma derivatives. NAT, on the other hand, is more likely to improve the safety of fresh blood components in relation to viruses that are not screened for at blood banks.

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