Pathogen-reduced Ebola virus convalescent plasma: first steps towards standardization of manufacturing and quality control including assessment of Ebola-specific neutralizing antibodies.
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Abstract
Background
Ebola virus disease is a public health emergency of international concern, and enormous efforts are being made in the development of vaccines and therapies. Ebola virus convalescent plasma is a promising anti‐infective treatment of Ebola virus disease. Therefore, we developed and implemented a pathogen‐reduced Ebola virus convalescent plasma concept in accordance with national, European and global regulatory framework.
Materials and Methods
Ebola virus convalescent plasma manufacture and distribution was managed by a collection centre, two medical centres and an expert group from the European Blood Alliance. Ebola virus convalescent plasma was collected twice with an interval of 61 days from a donor recovering from Ebola virus disease in Germany. After pathogen reduction, the plasma was analysed for Ebola virus‐specific immunoglobulin G (IgG) antibodies and its Ebola virus neutralizing activity.
Results
Convalescent plasma could be collected without adverse events. Anti‐Ebola virus IgG titres and Ebola‐specific neutralizing antibodies in convalescent plasma were only slightly reduced after pathogen reduction treatment with S59 amotosalen/UVA. A patient in Italy with Ebola virus disease was treated with convalescent plasma without apparent adverse effects.
Discussion
As proof of principle, we describe a concept and practical implementation of pathogen‐reduced Ebola virus convalescent plasma manufacture, quality control and its clinical application to an Ebola virus disease patient.
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