Biologicals : journal of the International Association of Biological Standardization
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Measurement of coagulation factor activity using absolute physico-chemical techniques is not possible and estimation therefore relies on comparative bioassay relative to a reference standard with a known or assigned potency. However the inherent variability of locally prepared and calibrated reference standards can give rise to poor agreement between laboratories and methods. Harmonisation of measurement between laboratories at the international level relies on the availability of a common source of calibration for local reference standards and this is provided by the World Health Organization (WHO) International Standards which define the International Unit for the analyte. This article describes the principles, practices and problems of biological standardisation and the development and use of reference standards for assays of coagulation factors, with particular emphasis on WHO International Standards for both concentrates and plasma.
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Injury is rapidly becoming the leading cause of death worldwide, and uncontrolled hemorrhage is the leading cause of potentially preventable death. In addition to crystalloid and/or colloid based resuscitation, severely injured trauma patients are routinely transfused RBCs, plasma, platelets, and in some centers either cryoprecipitate or fibrinogen concentrates or whole blood. Optimal timing and quantity of these products in the treatment of hypothermic, coagulopathic and acidotic trauma patients is unclear. ⋯ In fact data from the current war in Iraq and Afghanistan suggest otherwise. All of these factors have contributed to the current situation, whereby blood component therapy is highly variable and not driven by long term patient outcomes. This review will address the issues raised above and describe recent trauma patient outcome data utilizing predetermined plasma:platelet:RBC transfusion ratios and an ongoing prospective observational trauma transfusion study.
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In recent years, the Chilean Health Ministry has developed a strategy in order to improve the safety and opportunity of the blood supply through the creation of a nationally co-ordinated blood transfusion service, centralizing collection management, production and testing in three Blood Centers along the country and promoting voluntary, regular, blood donation. In 2007, a comprehensive study of the situation of Blood Transfusion Services in Chile concluded that several critical factors make it difficult to achieve a safe and adequate access to blood and blood components in the country. For example there is a low donation rate (14.3/1000 inhabitants), very low percentage of voluntary donors (10%), excessive amount of blood banks collecting, processing and testing blood revealing an atomized non-centralized system, lack of a national IT system and insufficient national standards. There are two regions in the country, Bio Bio and Valparaíso, where Regional Blood Centers are located, that have put in place several strategies in order to obtain better results.
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Cell substrates are a key component of successful vaccine development and throughout the last several decades there has been a dramatic increase in the types of cells available for vaccine production. Nevertheless, there is a continued demand for new and innovative approaches for vaccine development and manufacturing. ⋯ Here we review vaccine antigen production in plant-based systems as was presented by Dr. Vidadi Yusibov of Fraunhofer USA Center for Molecular Biotechnology at the IABS International Scientific Workshop on NEW CELLS FOR NEW VACCINES II that was held in Wilmington, Delaware on September 17-19, 2007.