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Hähnel, Viola ; Peterhoff, David ; Bäuerlein, Veronika ; Brosig, Andreas-Michael ; Palmer, Irene ; Johnson, Christian ; Bica, Adelina ; Totir, Monica ; Ossner, Thomas ; Stemmer, Barbara ; Toelge, Martina ; Schütz, Anja ; Niller, Hans-Helmut ; Schmidt, Barbara ; Wagner, Ralf ; Gessner, André ; Burkhardt, Ralph ; Offner, Robert

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

Hähnel, Viola, Peterhoff, David , Bäuerlein, Veronika, Brosig, Andreas-Michael, Palmer, Irene, Johnson, Christian , Bica, Adelina, Totir, Monica, Ossner, Thomas, Stemmer, Barbara, Toelge, Martina, Schütz, Anja, Niller, Hans-Helmut, Schmidt, Barbara, Wagner, Ralf, Gessner, André , Burkhardt, Ralph and Offner, Robert (2020) Manufacturing of convalescent plasma of COVID-19 patients: Aspects of quality. Plos One 15 (12), pp. 1-11.

Date of publication of this fulltext: 15 Mar 2021 11:31
Article
DOI to cite this document: 10.5283/epub.44813


Abstract

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 ...

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 degrees C) for up to 5 days or frozen (-30 degrees 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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Details

Item typeArticle
Journal or Publication TitlePlos One
Publisher:PLOS
Place of Publication:SAN FRANCISCO
Volume:15
Number of Issue or Book Chapter:12
Page Range:pp. 1-11
Date22 December 2020
InstitutionsMedicine > Lehrstuhl für Klinische Chemie und Laboratoriumsmedizin
Medicine > Lehrstuhl für Medizinische Mikrobiologie und Hygiene
Identification Number
ValueType
10.1371/journal.pone.0243967DOI
KeywordsCORONAVIRUS; PNEUMONIA; THERAPY; COV;
Dewey Decimal Classification600 Technology > 610 Medical sciences Medicine
StatusPublished
RefereedYes, this version has been refereed
Created at the University of RegensburgYes
URN of the UB Regensburgurn:nbn:de:bvb:355-epub-448130
Item ID44813

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