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Manufacturing of convalescent plasma of COVID-19 patients: Aspects of quality

The ongoing coronavirus disease 2019 (COVID-19) pandemic emerged in December 2019. Convalescent plasma represents a promising COVID-19 treatment. Here, we report on the manufacturing of a plasma-based product containing antibodies specific to SARS-CoV-2 obtained from recently recovered COVID-19 pati...

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Autores principales: Hähnel, Viola, Peterhoff, David, Bäuerlein, Veronika, Brosig, Andreas-Michael, Pamler, Irene, Johnson, Christian, Bica, Adelina, Totir, Monica, Ossner, Thomas, Stemmer, Barbara, Toelge, Martina, Schütz, Anja, Niller, Hans-Helmut, Schmidt, Barbara, Wagner, Ralf, Gessner, André, Burkhard, Ralph, Offner, Robert
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7755199/
https://www.ncbi.nlm.nih.gov/pubmed/33351831
http://dx.doi.org/10.1371/journal.pone.0243967
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author Hähnel, Viola
Peterhoff, David
Bäuerlein, Veronika
Brosig, Andreas-Michael
Pamler, Irene
Johnson, Christian
Bica, Adelina
Totir, Monica
Ossner, Thomas
Stemmer, Barbara
Toelge, Martina
Schütz, Anja
Niller, Hans-Helmut
Schmidt, Barbara
Wagner, Ralf
Gessner, André
Burkhard, Ralph
Offner, Robert
author_facet Hähnel, Viola
Peterhoff, David
Bäuerlein, Veronika
Brosig, Andreas-Michael
Pamler, Irene
Johnson, Christian
Bica, Adelina
Totir, Monica
Ossner, Thomas
Stemmer, Barbara
Toelge, Martina
Schütz, Anja
Niller, Hans-Helmut
Schmidt, Barbara
Wagner, Ralf
Gessner, André
Burkhard, Ralph
Offner, Robert
author_sort Hähnel, Viola
collection PubMed
description The ongoing coronavirus disease 2019 (COVID-19) pandemic emerged in December 2019. Convalescent plasma represents a promising COVID-19 treatment. Here, we report on the manufacturing of a plasma-based product containing antibodies specific to SARS-CoV-2 obtained from recently recovered COVID-19 patients. Convalescent plasma donors were screened as follows: 1) previously confirmed SARS-CoV-2 infection (by real-time PCR (RT-PCR)); 2) a subsequent negative PCR test followed by a 2-week waiting period; 3) an additional negative PCR test prior to plasmapheresis; and 4) confirmation of the presence of SARS-CoV-2 specific antibodies. Convalescent plasma was stored fresh (2–6°C) for up to 5 days or frozen (-30°C) for long-term storage. Donor peripheral blood and final plasma product were assayed for binding antibodies targeting the SARS-CoV-2 S-protein receptor-binding domain (RBD) and their titers measured by an enzyme-linked immunosorbent assay (ELISA). We performed 72 plasmaphereses resulting in 248 final products. Convalescent plasma contained an RBD-specific antibody titer (IgG) ranging from 1:100 to 1:3200 (median 1:800). The titer was congruent to the titer of the blood (n = 34) before collection (1:100–1:6400, median 1:800). Levels of IL-8 and LBP of donors were slightly increased. Therapeutic products derived from a human origin must undergo rigorous testing to ensure uniform quality and patient safety. Whilst previous publications recommended RBD-specific binding antibody titers of ≥ 1:320, we selected a minimum titer of 1:800 in order to maximize antibody delivery. Production of highly standardized convalescent plasma was safe, feasible and was readily implemented in the treatment of severely ill COVID-19 patients.
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spelling pubmed-77551992021-01-05 Manufacturing of convalescent plasma of COVID-19 patients: Aspects of quality Hähnel, Viola Peterhoff, David Bäuerlein, Veronika Brosig, Andreas-Michael Pamler, Irene Johnson, Christian Bica, Adelina Totir, Monica Ossner, Thomas Stemmer, Barbara Toelge, Martina Schütz, Anja Niller, Hans-Helmut Schmidt, Barbara Wagner, Ralf Gessner, André Burkhard, Ralph Offner, Robert PLoS One Research Article The ongoing coronavirus disease 2019 (COVID-19) pandemic emerged in December 2019. Convalescent plasma represents a promising COVID-19 treatment. Here, we report on the manufacturing of a plasma-based product containing antibodies specific to SARS-CoV-2 obtained from recently recovered COVID-19 patients. Convalescent plasma donors were screened as follows: 1) previously confirmed SARS-CoV-2 infection (by real-time PCR (RT-PCR)); 2) a subsequent negative PCR test followed by a 2-week waiting period; 3) an additional negative PCR test prior to plasmapheresis; and 4) confirmation of the presence of SARS-CoV-2 specific antibodies. Convalescent plasma was stored fresh (2–6°C) for up to 5 days or frozen (-30°C) for long-term storage. Donor peripheral blood and final plasma product were assayed for binding antibodies targeting the SARS-CoV-2 S-protein receptor-binding domain (RBD) and their titers measured by an enzyme-linked immunosorbent assay (ELISA). We performed 72 plasmaphereses resulting in 248 final products. Convalescent plasma contained an RBD-specific antibody titer (IgG) ranging from 1:100 to 1:3200 (median 1:800). The titer was congruent to the titer of the blood (n = 34) before collection (1:100–1:6400, median 1:800). Levels of IL-8 and LBP of donors were slightly increased. Therapeutic products derived from a human origin must undergo rigorous testing to ensure uniform quality and patient safety. Whilst previous publications recommended RBD-specific binding antibody titers of ≥ 1:320, we selected a minimum titer of 1:800 in order to maximize antibody delivery. Production of highly standardized convalescent plasma was safe, feasible and was readily implemented in the treatment of severely ill COVID-19 patients. Public Library of Science 2020-12-22 /pmc/articles/PMC7755199/ /pubmed/33351831 http://dx.doi.org/10.1371/journal.pone.0243967 Text en © 2020 Hähnel et al http://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Research Article
Hähnel, Viola
Peterhoff, David
Bäuerlein, Veronika
Brosig, Andreas-Michael
Pamler, Irene
Johnson, Christian
Bica, Adelina
Totir, Monica
Ossner, Thomas
Stemmer, Barbara
Toelge, Martina
Schütz, Anja
Niller, Hans-Helmut
Schmidt, Barbara
Wagner, Ralf
Gessner, André
Burkhard, Ralph
Offner, Robert
Manufacturing of convalescent plasma of COVID-19 patients: Aspects of quality
title Manufacturing of convalescent plasma of COVID-19 patients: Aspects of quality
title_full Manufacturing of convalescent plasma of COVID-19 patients: Aspects of quality
title_fullStr Manufacturing of convalescent plasma of COVID-19 patients: Aspects of quality
title_full_unstemmed Manufacturing of convalescent plasma of COVID-19 patients: Aspects of quality
title_short Manufacturing of convalescent plasma of COVID-19 patients: Aspects of quality
title_sort manufacturing of convalescent plasma of covid-19 patients: aspects of quality
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7755199/
https://www.ncbi.nlm.nih.gov/pubmed/33351831
http://dx.doi.org/10.1371/journal.pone.0243967
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