The recent outbreak of Ebola virus has caused great concern worldwide. We read stories about isolation, experimental therapies and many deaths. With the occurrence of the first transmissions of Ebola outside of West Africa, it becomes obvious that Ebola, as many other viruses originally confined to certain regions, can be introduced into other geographic areas through travelers who have visited countries where the virus is endemic.
PPTA understands that people who rely on plasma protein therapies may have concerns about the safety of these therapies, e.g., clotting factors, immune globulins, alpha-1 proteinase inhibitor, and albumin. PPTA members are committed to providing safe and effective therapies.
It is extremely unlikely that the Ebola virus would ever be introduced into a plasma pool for manufacturing of these therapies because donors undergo health screening before each donation and individuals are not permitted to donate if they have symptoms of viral infection (e.g. fever). A benefit of PPTA’s QSEAL program for Source Plasma is the 60-day Inventory Hold standard that allows units of plasma to be eliminated from plasma pools if additional safety information is learned following the 60 days after donation. Recovered plasma, another source for manufacture of plasma protein therapies, is prepared from whole blood donations. Individuals who have traveled to countries where Ebola is prevalent are currently deferred from blood donation because these areas are also considered at risk for malaria (1). Furthermore, in an abundance of caution, donors are being deferred if there is a possibility of exposure during the incubation period for Ebola (2, 3). PPTA members collecting Source Plasma are voluntarily following the 60-day deferral recommendation from the European Centre for Disease Prevention and Control (3). The longest incubation period for Ebola virus has been estimated at 25 days (4).
Ebola virus, a genus of the family of Filoviridae is an enveloped negative strand RNA virus with a diameter of 80 nm and 900 nm in length. Over the years, PPTA member companies have generated considerable data regarding the inactivation of enveloped viruses by processing steps in the manufacture of plasma protein therapies (5, 6, 7, 8, 9, 10). These data demonstrate that enveloped viruses are efficiently inactivated by commonly used inactivation methods. Moreover, filtration through 35 nm or 20 nm filters is a common manufacturing step for plasma protein therapies and is able to remove any particle with the size of the Ebola virus (11). PPTA’s consideration of 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.
- Joint Statement Regarding Eblola and the Safety of the Blood Supply. AABB, ABC, and ARC. 15 October 2014. http://www.aabb.org/advocacy/statements/Pages/statement141015.aspx
- The risk of transmission of Ebola virus via donated blood and other substances of human origin in the EU. ECDC PHE technical document. 6 October 2014. http://www.ecdc.europa.eu/en/publications/Publications/ebola-risk-transmission-via-donated-blood-substances-human-origin-october-2014.pdf
- Deferral for Blood Donation of Persons Under Public Health Surveillance for Possible Exposure to Ebola Virus. AABB Association Bulletin #14-08. 14 October 2014 http://www.aabb.org/programs/publications/bulletins/Documents/ab14-08.pdf
- Eichner et al. Incubation period of Ebola hemorrhagic virus subtype Zaire. Osong Public Health Res. Perspect. 2011. 2(1): 3-7
- Kreil et al. West Nile virus and the safety of plasma derivatives: verification of high safety margins, and the validity of predictions based on model virus data. Transfusion. 2003;43:1023-1028
- Dichtelmüller et al. Robustness of solvent/detergent treatment of plasma derivatives: a data collection from Plasma Protein Therapeutics Association member companies. Transfusion 2009;49:1931-1943
- Dichtelmüller et al. Inactivation of lipid enveloped viruses by octanoic acid treatment of immunoglobulin solution. Biologicals 2002;30:135-142
- Korneyeva et al. Enveloped virus inactivation by caprylate. A robust alternative to solvent-detergent treatment in plasma derived intermediates. Biologicals 2002;30: 153-162
- Stucki et al. Investigations of prion and virus safety of a new liquid IVIG product. Biologicals 2008;36:239-247
- Mitchell et al. Physicochemical Inactivation of Lassa, Ebola, and Marburg Viruses and Effect on Clinical Laboratory Analyses, J Clin Microbiol. 1984:20:486-489
- Dichtelmüller et al. Virus removal by nanofiltration with virus retentive filters during plasma protein manufacturing processes: a data collection from Plasma Protein Therapeutics Association member companies. Manuscript in preparation
Ethical Considerations in Compensated Plasma Donation +
PPTA's standards programs are cited in "Risk-based decision making and ethical considerations in donor compensation for plasma-derived medicinal products," in Transfusion. This Commentary concludes that there is no ethical basis for banning compensated plasma donation. Click here for the full article.Read More
Zika Virus and Plasma Protein Therapies +
Updated Sept. 8, 2016
Recent scientific and public press reports have heightened awareness of the emergence of Zika virus (ZIKV) in the Americas1, 2 and the causal relationship between prenatal ZIKV infection and microcephaly and other severe fetal brain defects3, 4.Read More
FDA Request to Cease Blood Collection in Florida +
PPTA is aware of the recent request by the FDA that blood establishments in Dade and Broward counties in the State of Florida cease blood collection. This request has been made as a “prudent measure” because State health officials are investigating a number of Zika infections that are not associated with travel to Zika-affected areas and may represent local transmission of the Zika virus.Read More