PUBLICATIONS AND PresentationS

Plasma protein therapies (PPTs) are biologic medicines that provide critical health benefits, especially for patients with plasma protein deficiencies. Plasma protein deficiencies are a group of chronic, serious, and mostly rare conditions that occur when a person has deficient or functionally damaged proteins in plasma—the liquid portion of blood.

Source plasma donor hemovigilance activities and results.

Following the meeting of the Blood Commission on November 16, 2011, where the Amrein et al. study of plateletpheresis donors that reported bone mineral density (BMD) losses at one of three skeletal sites was associated with donating platelets1 was discussed, the Plasma Protein Therapeutics Association (PPTA) was asked to respond to the suggestion that Source Plasma donors, with their high-frequency, high-volume donations, were at risk of BMD loss. The industry has evaluated the Amrein et al. study, conducted extensive literature surveys to see if similar findings had been published, and assessed risk to plasma donors looking at the comparison of the exposures to citrate that plasma and platelet donors would receive during the apheresis collection process. The result of this analysis is presented in this paper to address the Blood Commission’s concerns.

Virus removal by partitioning into different fractions during cold ethanol fractionation has been described by several authors, demonstrating that cold ethanol fractionation can provide significant contribution to virus removal, even in those cases where virus removal is limited and must be supported by additional measures for virus inactivation during further processing.