Production and Quality Assurance of Human Polyclonal Hyperimmune Immunoglobulins Against SARS-CoV-2

Affiliations

¹ College of Biomedical Engineering, Graduate Institute of Biomedical Materials and Tissue Engineering, Taipei Medical University, Taipei, Taiwan; International PhD Program in Biomedical Engineering, College of Biomedical Engineering, Taipei Medical University, Taipei, Taiwan. Electronic address: thburnouf@gmail.com.
² Department of Transfusion Medicine, University Hospital of Cologne, Köln, Germany. Electronic address: Birgit.Gathof@uk-koeln.de.
³ Division of Transfusion Medicine, Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
⁴ Héma-Québec, Medical Affairs and Innovation, Québec, Canada.
⁵ National Blood Centre, Italian National Institute of Health, Rome, Italy.
⁶ Department of Transfusion Medicine, All India Institute of Medical Sciences, New Delhi, India.
⁷ Institute for Transfusion Medicine of RNM, Skopje, North Macedonia; Faculty of Medical Sciences, University Goce Delcev, Štip, North Macedonia.
⁸ Department of Planning, Research and Statistics, National Blood Service Commission, Federal Ministry of Health, Abuja, Nigeria.
⁹ Division of Transfusion Medicine, Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA; Division of Hematology/Oncology, Simmons Cancer Institute at SIU School of Medicine and ImpactLife Blood Center, Springfield, IL, USA.
¹⁰ Blood Bank, Shamir Medical Center, Assaf Harofeh MC, Zerifin, Israel.
¹¹ Haematology Department, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia.
¹² Department of Hematology, Sultan Qaboos University Hospital, Muscat, Sultanate of Oman.
¹³ Department of Haematology, Erasmus Medical Centre, Rotterdam, The Netherlands; Unit Transfusion Medicine, Sanquin Blood Supply Foundation, Amsterdam, The Netherlands.

PMID: 35879213
PMCID: PMC9183240
DOI: 10.1016/j.tmrv.2022.06.001

Production and Quality Assurance of Human Polyclonal Hyperimmune Immunoglobulins Against SARS-CoV-2

Thierry Burnouf et al. Transfus Med Rev. 2022 Jul.

. 2022 Jul;36(3):125-132.

doi: 10.1016/j.tmrv.2022.06.001. Epub 2022 Jun 9.

Authors

Affiliations

¹ College of Biomedical Engineering, Graduate Institute of Biomedical Materials and Tissue Engineering, Taipei Medical University, Taipei, Taiwan; International PhD Program in Biomedical Engineering, College of Biomedical Engineering, Taipei Medical University, Taipei, Taiwan. Electronic address: thburnouf@gmail.com.
² Department of Transfusion Medicine, University Hospital of Cologne, Köln, Germany. Electronic address: Birgit.Gathof@uk-koeln.de.
³ Division of Transfusion Medicine, Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
⁴ Héma-Québec, Medical Affairs and Innovation, Québec, Canada.
⁵ National Blood Centre, Italian National Institute of Health, Rome, Italy.
⁶ Department of Transfusion Medicine, All India Institute of Medical Sciences, New Delhi, India.
⁷ Institute for Transfusion Medicine of RNM, Skopje, North Macedonia; Faculty of Medical Sciences, University Goce Delcev, Štip, North Macedonia.
⁸ Department of Planning, Research and Statistics, National Blood Service Commission, Federal Ministry of Health, Abuja, Nigeria.
⁹ Division of Transfusion Medicine, Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA; Division of Hematology/Oncology, Simmons Cancer Institute at SIU School of Medicine and ImpactLife Blood Center, Springfield, IL, USA.
¹⁰ Blood Bank, Shamir Medical Center, Assaf Harofeh MC, Zerifin, Israel.
¹¹ Haematology Department, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia.
¹² Department of Hematology, Sultan Qaboos University Hospital, Muscat, Sultanate of Oman.
¹³ Department of Haematology, Erasmus Medical Centre, Rotterdam, The Netherlands; Unit Transfusion Medicine, Sanquin Blood Supply Foundation, Amsterdam, The Netherlands.

PMID: 35879213
PMCID: PMC9183240
DOI: 10.1016/j.tmrv.2022.06.001

Abstract

The coronavirus disease 2019 (COVID-19) pandemic has highlighted the potential therapeutic value of early passive polyclonal immunotherapy using high-titer convalescent plasma (CCP). Human polyclonal hyperimmune immunoglobulin (HIG) has several advantages over CCP. Unlike CCP, HIG can provide standardized and controlled antibody content. It is also subjected to robust pathogen reduction rendering it virally safe and is purified by technologies demonstrated to preserve immunoglobulin neutralization capacity and Fc fragment integrity. This document provides an overview of current practices and guidance for the collection and testing of plasma rich in antibodies against Severe Acute Respiratory Coronavirus 2 (SARS-CoV-2) and its industrial fractionation for the manufacture of quality-assured and safe HIG. Considerations are also given to the production of HIG preparations in low- and middle-income countries.

Keywords: COVID-19; Convalescent plasma; Human hyperimmune immunoglobulins; Passive immunotherapy; SARS-CoV-2.

PubMed Disclaimer

Cited by

Uses and Challenges of Antiviral Polyclonal and Monoclonal Antibody Therapies.
Struble EB, Rawson JMO, Stantchev T, Scott D, Shapiro MA. Struble EB, et al. Pharmaceutics. 2023 May 19;15(5):1538. doi: 10.3390/pharmaceutics15051538. Pharmaceutics. 2023. PMID: 37242780 Free PMC article. Review.
The role of convalescent plasma and hyperimmune immunoglobulins in the COVID-19 pandemic, including implications for future preparedness.
So-Osman C, Burnouf T, Al-Riyami AZ, Bloch EM, Estcourt L, Goel R, Tiberghien P, Vermeulen M, Wendel S, Wood EM. So-Osman C, et al. Front Immunol. 2024 Sep 9;15:1448720. doi: 10.3389/fimmu.2024.1448720. eCollection 2024. Front Immunol. 2024. PMID: 39315108 Free PMC article. Review.
Validation of Viral Inactivation Protocols for Therapeutic Blood Products against Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-COV-2).
Belem WF, Liu CH, Hu YT, Burnouf T, Lin LT. Belem WF, et al. Viruses. 2022 Oct 31;14(11):2419. doi: 10.3390/v14112419. Viruses. 2022. PMID: 36366517 Free PMC article.
The Potential Role of Passive Antibody-Based Therapies as Treatments for Monkeypox.
Bloch EM, Sullivan DJ, Shoham S, Tobian AAR, Casadevall A, Gebo KA. Bloch EM, et al. mBio. 2022 Dec 20;13(6):e0286222. doi: 10.1128/mbio.02862-22. Epub 2022 Oct 31. mBio. 2022. PMID: 36314809 Free PMC article. Review.
Passive antibody therapy in emerging infectious diseases.
Yang X. Yang X. Front Med. 2023 Dec;17(6):1117-1134. doi: 10.1007/s11684-023-1021-y. Epub 2023 Dec 2. Front Med. 2023. PMID: 38040914 Review.

See all "Cited by" articles

References

1. John Hopkins University of Medicine. Coronavirus COVID-19 global cases by the center for systems science and engineering at Johns Hopkins. 2022. Accessed from: https://coronavirus.jhu.edu/map.html (Accessed at: July 18, 2022).
1. Shen C, Wang Z, Zhao F, Yang Y, Li J, Yuan J, et al. Treatment of 5 critically Ill patients with COVID-19 with convalescent plasma. JAMA. 2020;323:1582–1589. - PMC - PubMed
1. Duan K, Liu B, Li C, Zhang H, Yu T, Qu J, et al. Effectiveness of convalescent plasma therapy in severe COVID-19 patients. Proc Natl Acad Sci U S A. 2020;117:9490–9496. - PMC - PubMed
1. Senefeld JW, Johnson PW, Kunze KL, Bloch EM, van Helmond N, Golafshar MA, et al. Access to and safety of COVID-19 convalescent plasma in the United States expanded access program: a national registry study. PLoS Med. 2021;18 - PMC - PubMed
1. Korley FK, Durkalski-Mauldin V, Yeatts SD, Schulman K, Davenport RD, Dumont LJ, et al. Early convalescent plasma for high-risk outpatients with Covid-19. N Engl J Med. 2021;385:1951–1960. - PMC - PubMed

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions

Substances

Actions

LinkOut - more resources

Full Text Sources
Medical
- MedlinePlus Health Information
Miscellaneous
- NCI CPTAC Assay Portal

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

Production and Quality Assurance of Human Polyclonal Hyperimmune Immunoglobulins Against SARS-CoV-2

Affiliations

Production and Quality Assurance of Human Polyclonal Hyperimmune Immunoglobulins Against SARS-CoV-2

Authors

Affiliations

Abstract

Similar articles

Cited by

References

MeSH terms

Substances

LinkOut - more resources

Full Text Sources

Medical

Miscellaneous