For more information about the plasma donation and collection process, visit www.GrifolsPlasma.com
Since product launch in 1997, there has never been a confirmed case of virus or prion transmission with ALPHANATE.
The manufacturing process for ALPHANATE was investigated for its capacity to decrease infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the CJD and vCJD agents. TSE reduction steps include: 3.5% polyethylene glycol precipitation, affinity chromatography, and saline precipitation.
These studies provide reasonable assurance that low levels of vCJD and CJD agent infectivity, if present in the starting material, would be removed.
*Grifols internal source—2015.
†Plasmapheresis is the process of separating blood cells from blood plasma. It is used in the process of donating plasma. It was developed by Grifols in 1951.