A safer plasma supply from remunerated donors--"The Immuno/Community Bio-Resources experiment"

With the goal of increasing the safety of plasma used in the manufacture of therapeutic products, Immuno and its subsidiary Community Bio-Resources (now a division of Baxter Healthcare Corporation), have developed a comprehensive plasma quality programme. This programme includes four main safety initiatives: a plasma centre location/appearance programme, a Qualified Donor programme, an Inventory Hold, and the PCR testing of plasma pools. Many of these initiatives have been adopted in part by the plasma collection and fractionation industry. Using a statistical model that takes into consideration the unique donation characteristics of remunerated plasma donors, combined with 1998 CBR virus reactive rates, an estimated residual likelihood of an undetected donation entering a plasma pool was determined. These estimates, for each million donations, were 0, 1.64, and 4.68 donations for HIV, HBV, and HCV, respectively, and were far below those previously reported for remunerated or volunteer donations. These estimates were confirmed by subsequent PCR testing, which allowed for the additional removal of positive units before manufacture. The low virus load of this plasma supply, combined with increasingly effective virus removal and inactivation procedures, has resulted in the safest ever supply of plasma derivatives.