During International Plasma Awareness Week, October 12-18, 2014, the Plasma Protein Therapeutics Association (PPTA) issued a news release to address the Ebola virus outbreak and any potential implications for plasma protein-based therapies. PPTA is a worldwide association of manufacturers of products made from human plasma, such as clotting factor concentrates. The group represents more than 450 human plasma collection centers in North America and Europe, plus manufacturers of life-saving plasma protein therapies. Members produce approximately 80% of the plasma protein therapies in the US and 60% of those manufactured in Europe.
PPTA explains that Ebola is genus within the family of enveloped negative strand RNA viruses known as Filoviridae, which originated in rain forests in Central Africa and Southeast Asia. The longest estimated incubation period for the virus is 25 days. In light of this, the PPTA Source Board endorsed a recommendation on October 13, 2014, for implementing a voluntary deferral of 60 days as a safeguard for potential plasma donors returning from Ebola virus disease affected areas.
PPTA also states it is “unlikely” that the Ebola virus would be introduced into the pools of human plasma used in manufacturing because any individuals exhibiting symptoms of viral infection, such as fever, are prohibited from making donations. In the unlikely scenario in which a plasma donor developed an Ebola infection, explains PPTA, the inventory hold period would allow ample time for donations to be identified, removed from inventory and destroyed prior to the beginning of manufacturing. PPTA went on to reassure the public of multiple viral inactivation/removal methods used in the manufacturing of human plasma-derived factor products and their proven effectiveness in clearing viruses comparable in size to Ebola.
“PPTA considered relevant information on Ebola virus and the available data indicate that plasma protein therapies manufactured by PPTA member companies provide high margins of safety against Ebola transmission,” concludes the release.
Source: PPTA news release dated October 13, 2014
