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BACKGROUND Hepatitis E virus (HEV) has been transmitted by transfusion of labile blood products and the occasional detection of HEV RNA in plasma pools indicates that HEV viremic donations might enter the manufacturing process of plasma products. To verify the safety margins of plasma products with respect to HEV, virus reduction steps commonly used in(More)
The 1999 introduction of West Nile virus (WNV) into the United States has resulted in the largest epidemic of arboviral illness in the Western Hemisphere, with an estimated 2.5 million cases of mostly asymptomatic human infections since then. As a consequence, an increasing occurrence of WNV antibodies in plasma collected in the United States, and thus in(More)
BACKGROUND Persons with primary immune deficiency receive intravenous immunoglobulin (IVIG) as antibody replacement therapy. These patients depend on the presence of protective antibody levels against circulating pathogens in IVIG. OBJECTIVES The incidence of hepatitis A virus (HAV) infections has been decreasing globally. We investigated whether this(More)
Porcine circovirus-1 (PCV1) was recently identified as a contaminant in live Rotavirus vaccines, which was likely caused by contaminated porcine trypsin. The event triggered the development of new regulatory guidance on the use of porcine trypsin which shall ensure that cell lines and porcine trypsin in use are free from PCV1. In addition, manufacturing(More)
BACKGROUND Human parvovirus B19 (B19V) is a highly prevalent pathogen, and plasma pools for manufacturing of plasma-derived products have been shown to contain antibodies against B19V (B19V immunoglobulin G [IgG]). STUDY DESIGN AND METHODS The megakaryoblastic cell line UT7/Epo-S1 can be infected with B19V Genotype 1 and as demonstrated here by(More)
This study investigated the association of ongoing West Nile virus (WNV) infections with neutralizing antibody titers in US plasma-derived intravenous immune globulin released during 2003-2008. Titers correlated closely with the prevalence of past WNV infection in blood donors, with 2008 lots indicating a prevalence of 1%.
BACKGROUND Freeze-drying is a technology widely used during the production of plasma-derived medicinal products. Several studies have shown that freeze-drying can also result in virus inactivation and particularly of hepatitis A virus (HAV). To date, however, the variables critical for virus inactivation during freeze-drying have not been investigated(More)
The testing for adventitious viruses is of critical importance during development and production of biological products. The recent emergence and ongoing development of broad virus detection methods calls for an evaluation of whether these methods can appropriately be implemented into current adventitious agent testing procedures. To assess the suitability(More)
BACKGROUND Chikungunya virus (CHIKV) outbreaks were previously restricted to parts of Africa, Indian Ocean Islands, South Asia, and Southeast Asia. In 2007, however, the first autochthonous CHIKV transmission was reported in Europe. High-level viremia, a mosquito vector that is also present in large urban areas of Europe and America, and uncertainty around(More)
BACKGROUND Pasteurization of human serum albumin (HSA) is detailed in the US and European Pharmacopoeial monographs and therefore a process that allows for little variation in physiochemical variables. Nevertheless, differences of up to 3.9 log in hepatitis A virus (HAV) inactivation by pasteurization have been reported. Here, the hypothesis that the choice(More)