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Research Article
Rising anti-SARS-CoV-2 titer in a human immunoglobulin preparation
1 Laboratory Head, Bioanalysis, Preclinical Research, Biotest AG, Dreieich, Hessen, Germany
2 Laboratory Head, Analytical Development and Validation Biotest AG, Dreieich, Hessen, Germany
3 Director, Bioanalysis, Preclinical Research, Biotest AG, Dreieich, Hessen, Germany
4 CSO, Biotest AG, Dreieich, Hessen, Germany
5 Vice President Preclinical Research, Biotest AG, Dreieich, Hessen, Germany
Address correspondence to:
Matthias Germer
Biotest AG, Landsteinerstrasse 3, 63303 Dreieich, Hessen,
Germany
Message to Corresponding Author
Article ID: 100076Z02CH2023
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How to cite this article
Hein C, Marschall V, Braun V, Schüttrumpf J, Germer M. Rising anti-SARS-CoV-2 titer in a human immunoglobulin preparation. Int J Blood Transfus Immunohematol 2023;13(1):1–8.ABSTRACT
Aims: To assess potential changes of pharmacological activities of a novel normal immunoglobulin for intravenous administration from pooled normal plasma (IVIG).
Methods: We assessed the impact of the SARS-CoV-2 pandemic on the level and activity of pathogen-specific antibodies in IVIG batches produced before and during the pandemic. Antibody levels were determined by immunoassays. The functional activity of SARS-CoV-2 antibodies was determined by in vitro neutralization.
Results: In the IVIG, the antibody titer against bacteria, different viruses and a fungus were found to be in a defined range, whereas titers to common pathogens remained consistent over time, the level of antibodies to SARS-CoV-2 have increased within two years after onset of the pandemic to levels comparable to a hyperimmunoglobulin preparation. These antibodies could neutralize SARS-CoV-2 and cross-react with other coronaviruses.
Conclusion: Increasing titers of SARS-CoV-2 antibodies might be beneficial for special vulnerable patient groups.
Keywords: Coronavirus, Intravenous immunoglobulins, Immunotherapy, Passive immunization, Plasma, SARS-CoV-2
SUPPORTING INFORMATION
Acknowledgments
The contributions of the entire Bioanalysis and Analytical Development and Validation teams, most notably Irina Beidokat and Nadine Feldmann, are gratefully acknowledged.
Author ContributionsChristopher Hein - Conception of the work, Design of the work, Analysis of data, Drafting the work, Final approval of the version to be published, Agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Viola Marschall - Acquisition of data, Analysis of data, Revising the work critically for important intellectual content, Final approval of the version to be published, Agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Veit Braun - Conception of the work, Design of the work, Acquisition of data, Analysis of data, Revising the work critically for important intellectual content, Final approval of the version to be published, Agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Jörg Schüttrumpf - Conception of the work, Design of the work, Analysis of data, Revising the work critically for important intellectual content, Final approval of the version to be published, Agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Matthias Germer - Conception of the work, Design of the work, Analysis of data, Revising the work critically for important intellectual content, Final approval of the version to be published, Agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Guarantor of SubmissionThe corresponding author is the guarantor of submission.
Source of SupportNone
Consent StatementWritten informed consent was obtained from the patient for publication of this article.
Data AvailabilityAll relevant data are within the paper and its Supporting Information files.
Conflict of InterestAuthors declare no conflict of interest.
Copyright© 2023 Christopher Hein et al. This article is distributed under the terms of Creative Commons Attribution License which permits unrestricted use, distribution and reproduction in any medium provided the original author(s) and original publisher are properly credited. Please see the copyright policy on the journal website for more information.
