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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 type | Article | ||||
| Journal or Publication Title | Plos One | ||||
| Publisher: | PLOS | ||||
|---|---|---|---|---|---|
| Place of Publication: | SAN FRANCISCO | ||||
| Volume: | 15 | ||||
| Number of Issue or Book Chapter: | 12 | ||||
| Page Range: | pp. 1-11 | ||||
| Date | 22 December 2020 | ||||
| Institutions | Medicine > Lehrstuhl für Klinische Chemie und Laboratoriumsmedizin Medicine > Lehrstuhl für Medizinische Mikrobiologie und Hygiene | ||||
| Identification Number |
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| Keywords | CORONAVIRUS; PNEUMONIA; THERAPY; COV; | ||||
| Dewey Decimal Classification | 600 Technology > 610 Medical sciences Medicine | ||||
| Status | Published | ||||
| Refereed | Yes, this version has been refereed | ||||
| Created at the University of Regensburg | Yes | ||||
| URN of the UB Regensburg | urn:nbn:de:bvb:355-epub-448130 | ||||
| Item ID | 44813 |
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