Collection of source material from remunerated donors.
The collection of plasma for further manufacture into medicinal products and in vitro diagnostic reagents is predominantly accomplished in the USA through the remuneration of donors who participate in plasmapheresis programmes. A well regulated system under the control of the Food and Drug Administration has been in place since the mid-1970s. Requirements of this regulatory system with regard to the need for donor acceptance and frequency of participation criteria, and plasma acceptability standards are reviewed. Information regarding several groups of donors participating in plasmapheresis procedures at various frequency intervals over 10 years is presented. Data on microhaematocrit, body weight, total protein, and individual serum protein distribution have been compiled and statistically analysed; the results of these analyses are included. Given the existence of a comprehensive approach which encompasses donor safety, plasma testing, and effective manufacturing procedures, safe and efficacious plasma derivatives can be produced from plasma drawn from remunerated donors and can be made available in sufficient quantity to meet medical needs in an economic manner.
Rodell
M B
MB
MBR Consulting Services, Dresher, PA.
D001688:Biological Products / Q000191:economics* / Q000592:standards; D001782:Blood Donors; D003140:Communicable Disease Control; D006801:Humans; D010949:Plasma; D010956:Plasmapheresis / Q000191:economics* / Q000592:standards; D012449:Safety; D009927:Tissue and Organ Procurement / Q000191:economics* / Q000592:standards
D001688:Biological Products