International Plasma Collection Practices: Project Report

Plasma is used by pharmaceutical companies to make plasma-derived medicinal products (PDMPs). PDMPs are used to treat conditions such as immune deficiencies and bleeding disorders. Several PDMPS are included in the WHO Model Lists of Essential Medicines. According to the WHO, self-sufficiency driven by voluntary (non-remunerated) plasma donations is an important national goal to ensure an adequate supply is secured to meet the needs of the population. Australia, New Zealand, the UK, the Netherlands, and France only allow public or not-for-profit sectors to collect plasma for fractionation. Each of the 5 countries have toll or contract agreements with 1 private commercial plasma fractionator to manufacture PDMPs from the plasma collected within their respective countries. None of these countries pay plasma donors. Donors are only permitted to donate every 2 weeks (24 to 26 times per year) in these 5 countries. Austria, the Czech Republic, Germany, and the US allow both public and non-for-profit sectors, as well as commercial private plasma collection centres, to operate in the country. Private, not-for-profit, or public plasma collection centres in these 4 countries offer monetary compensation and other in-kind incentives to plasma donors. While the Czech Republic limits plasma donation to every 2 weeks, a much higher frequency of donation is allowed in other countries; up to 50 times per year in Austria, 60 times per year in Germany, and more than 100 times per year in the US. Austria, the Czech Republic, Germany, and the US (which allow commercial private plasma collectors to operate and pay donors) are 100% self-sufficient in immunoglobulins. These 4 countries collect the most plasma, which is from paid donors. In 2017, Austria, the Czech Republic, Germany, and the US collected 75 litres per 1,000 people, 45 litres per 1,000 people, 36 litres per 1,000 people, and 113 litres per 1,000 people of plasma for fractionation, respectively. Countries that do not pay donors including Australia, New Zealand, the UK, the Netherlands, and France are dependent to some extent on US and European Union donors who are paid for the supply of plasma or imported PDMPs. The limited literature search conducted for the Environmental Scan did not identify publications on events of disease transmission through PDMPs manufactured from either paid or non-renumerated donors’ plasma, the impact of plasma collection centres (including those that do or do not pay donors) on the collection of whole blood or other blood components, or the long-term costs associated with plasma self-sufficiency on the health care system.

Study of the Stability of Factor VIII Activity in Human Plasma for Fractionation When Modeling Deviations in the Storage and Transportation Temperature Conditions

The European Pharmacopoeia requires that the transportation and storage of human plasma for fractionation should be carried out at –20 °C or below, while allowing for some deviations in the temperature regime. The current Russian regulatory documentation requires the transportation and storage of plasma intended for the production of labile protein preparations (blood clotting factors) at –30 °C or lower. However, acceptable deviations from the temperature regime are not specified, which creates certain difficulties in their assessment by an authorised person during plasma batch release. The main tool in risk assessment is in-process control of factor VIII activity in plasma stored at inadequate temperature, which entails significant financial costs. The aim of the study was to assess stability of factor VIII activity in human plasma for fractionation when modeling deviations in the storage and transportation temperature regime and to assess the possibility of amending the regulatory documentation requirements. Materials and methods: only full individual doses of plasma obtained by apheresis were used in the experiments. The tests were performed under simulated high temperature conditions with accurate continuous recording of temperature by a measuring system. An automatic coagulation analyser was used to determine factor VIII activity. Quantitative evaluation of the results was carried out by comparing factor VIII activity in the plasma before freezing and in the tested plasma. Statistical processing of data was performed by descriptive statistics methods using Microsoft Excel 2007 applications. Results: no significant effect of short-term deviations in the storage temperature on the stability of factor VIII activity in human plasma for fractionation was observed. Conclusions: the obtained data can be used as a rationale for introducing changes in the official requirements for the storage and transportation temperature regime for human plasma for fractionation, as well as for including details of acceptable short-term deviations of the storage and transportation temperature regime in the regulatory documentation.