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

COVID-19 Convalescent plasma Human hyperimmune immunoglobulins Passive immunotherapy SARS-CoV-2

Journal

Transfusion medicine reviews
ISSN: 1532-9496
Titre abrégé: Transfus Med Rev
Pays: United States
ID NLM: 8709027

Informations de publication

Date de publication:
07 2022
Historique:
received: 28 04 2022
revised: 01 06 2022
accepted: 02 06 2022
pubmed: 26 7 2022
medline: 14 9 2022
entrez: 25 7 2022
Statut: ppublish

Résumé

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.

Identifiants

pubmed: 35879213
pii: S0887-7963(22)00021-9
doi: 10.1016/j.tmrv.2022.06.001
pmc: PMC9183240
pii:
doi:

Substances chimiques

Antibodies 0

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

125-132

Informations de copyright

Copyright © 2022 Elsevier Inc. All rights reserved.

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Auteurs

Thierry Burnouf (T)

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.

Birgit Gathof (B)

Department of Transfusion Medicine, University Hospital of Cologne, Köln, Germany. Electronic address: Birgit.Gathof@uk-koeln.de.

Evan M Bloch (EM)

Division of Transfusion Medicine, Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.

Renée Bazin (R)

Héma-Québec, Medical Affairs and Innovation, Québec, Canada.

Vincenzo de Angelis (V)

National Blood Centre, Italian National Institute of Health, Rome, Italy.

Gopal Kumar Patidar (GK)

Department of Transfusion Medicine, All India Institute of Medical Sciences, New Delhi, India.

Rada M Grubovic Rastvorceva (RMG)

Institute for Transfusion Medicine of RNM, Skopje, North Macedonia; Faculty of Medical Sciences, University Goce Delcev, Štip, North Macedonia.

Adaeze Oreh (A)

Department of Planning, Research and Statistics, National Blood Service Commission, Federal Ministry of Health, Abuja, Nigeria.

Ruchika Goel (R)

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.

Naomi Rahimi-Levene (N)

Blood Bank, Shamir Medical Center, Assaf Harofeh MC, Zerifin, Israel.

Salwa Hindawi (S)

Haematology Department, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia.

Arwa Z Al-Riyami (AZ)

Department of Hematology, Sultan Qaboos University Hospital, Muscat, Sultanate of Oman.

Cynthia So-Osman (C)

Department of Haematology, Erasmus Medical Centre, Rotterdam, The Netherlands; Unit Transfusion Medicine, Sanquin Blood Supply Foundation, Amsterdam, The Netherlands.

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