Universität zu Köln

Burnouf, Thierry ORCID: 0000-0002-0507-9243, Gathof, Birgit, Bloch, Evan M., Bazin, Renee ORCID: 0000-0001-9594-2532, de Angelis, Vincenzo, Patidar, Gopal Kumar ORCID: 0000-0001-9681-3898, Rastvorceva, Rada M. Grubovic, Oreh, Adaeze ORCID: 0000-0001-9141-8215, Goel, Ruchika ORCID: 0000-0001-9653-9905, Rahimi-Levene, Naomi ORCID: 0000-0003-3411-886X, Hindawi, Salwa, Al-Riyami, Arwa Z. and So-Osman, Cynthia (2022). Production and Quality Assurance of Human Polyclonal Hyperimmune Immunoglobulins Against SARS-CoV-2. Transf. Med. Rev., 36 (3). S. 125 - 133. PHILADELPHIA: W B SAUNDERS CO-ELSEVIER INC. ISSN 1532-9496

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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 stan-dardized 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 ca-pacity 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. Con-siderations are also given to the production of HIG preparations in low-and middle-income countries.(c) 2022 Elsevier Inc. All rights reserved.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Burnouf, Thierry UNSPECIFIED orcid.org/0000-0002-0507-9243 UNSPECIFIED Gathof, Birgit UNSPECIFIED UNSPECIFIED UNSPECIFIED Bloch, Evan M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Bazin, Renee UNSPECIFIED orcid.org/0000-0001-9594-2532 UNSPECIFIED de Angelis, Vincenzo UNSPECIFIED UNSPECIFIED UNSPECIFIED Patidar, Gopal Kumar UNSPECIFIED orcid.org/0000-0001-9681-3898 UNSPECIFIED Rastvorceva, Rada M. Grubovic UNSPECIFIED UNSPECIFIED UNSPECIFIED Oreh, Adaeze UNSPECIFIED orcid.org/0000-0001-9141-8215 UNSPECIFIED Goel, Ruchika UNSPECIFIED orcid.org/0000-0001-9653-9905 UNSPECIFIED Rahimi-Levene, Naomi UNSPECIFIED orcid.org/0000-0003-3411-886X UNSPECIFIED Hindawi, Salwa UNSPECIFIED UNSPECIFIED UNSPECIFIED Al-Riyami, Arwa Z. UNSPECIFIED UNSPECIFIED UNSPECIFIED So-Osman, Cynthia UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-694073
DOI:	10.1016/j.tmrv.2022.06.001
Journal or Publication Title:	Transf. Med. Rev.
Volume:	36
Number:	3
Page Range:	S. 125 - 133
Date:	2022
Publisher:	W B SAUNDERS CO-ELSEVIER INC
Place of Publication:	PHILADELPHIA
ISSN:	1532-9496
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language INTRAVENOUS IMMUNOGLOBULIN; NEUTRALIZING ANTIBODIES; CONVALESCENT PLASMA; SAFETY; STANDARD; IMMUNOGENICITY; INFECTION; EFFICACY; SPIKE; IGA Multiple languages Hematology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/69407