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

Thierry Burnouf*, Birgit Gathof*, Evan M. Bloch, Renée Bazin, Vincenzo de Angelis, Gopal Kumar Patidar, Rada M. Grubovic Rastvorceva, Adaeze Oreh, Ruchika Goel, Naomi Rahimi-Levene, Salwa Hindawi, Arwa Z. Al-Riyami, Cynthia So-Osman

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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.

Original languageEnglish
Pages (from-to)125-132
Number of pages8
JournalTransfusion Medicine Reviews
Volume36
Issue number3
DOIs
Publication statusPublished - Jul 2022

Bibliographical note

On behalf of theISBT COVID-19 Convalescent Plasma Working Group

Publisher Copyright: © 2022 Elsevier Inc.

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