On Sept. 21, 2016, the European Medicines
Agency (EMA) announced there is no increased risk of Zika contamination for
patients who take plasma- or urine-derived drugs. The conclusion was made after
an assessment was carried out by EMA and authorities in EU Member States to
determine if drugs produced from body fluids, which might be sourced from parts
of the world where Zika is prevalent, could contaminate the final product with
the virus.
EMA’s Committee for Medicinal Products for
Human Use (CHMP) concluded that manufacturing processes such as
solvent/detergent methods, pasteurization, and virus filtration inactivate or
remove the Zika virus from the finished product. Steps for the
inactivation/removal capacity for enveloped viruses are included in the
manufacturing processes for urine-derived products. CHMP considers these steps
sufficient to keep patients safe from Zika contamination.
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