Hahnel, Viola and Peterhoff, David and Bauerlein, Veronika and Brosig, Andreas-Michael and Pamler, Irene and Johnson, Christian and Bica, Adelina and Totir, Monica and Ossner, Thomas and Stemmer, Barbara and Toelge, Martina and Schutz, Anja and Niller, Hans-Helmut and Schmidt, Barbara and Wagner, Ralf and Gessner, Andre and Burkhard, Ralph and Offner, Robert (2020) Manufacturing of convalescent plasma of COVID-19 patients: Aspects of quality. PLOS ONE, 15 (12): e0243967. ISSN 1932-6203,
Full text not available from this repository. (Request a copy)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 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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | CORONAVIRUS; PNEUMONIA; THERAPY; COV; |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Klinische Chemie und Laboratoriumsmedizin Medicine > Lehrstuhl für Medizinische Mikrobiologie und Hygiene |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 05 Mar 2021 07:23 |
| Last Modified: | 05 Mar 2021 07:23 |
| URI: | https://pred.uni-regensburg.de/id/eprint/43098 |
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