TY - JOUR
T1 - Production and Quality Assurance of Human Polyclonal Hyperimmune Immunoglobulins Against SARS-CoV-2
AU - ISBT COVID-19 Convalescent Plasma Working Group (see the Appendix)
AU - Burnouf, Thierry
AU - Gathof, Birgit
AU - Bloch, Evan M.
AU - Bazin, Renée
AU - de Angelis, Vincenzo
AU - Patidar, Gopal Kumar
AU - Rastvorceva, Rada M.Grubovic
AU - Oreh, Adaeze
AU - Goel, Ruchika
AU - Rahimi-Levene, Naomi
AU - Hindawi, Salwa
AU - Al-Riyami, Arwa Z.
AU - So-Osman, Cynthia
N1 - Publisher Copyright:
© 2022 Elsevier Inc.
PY - 2022/7
Y1 - 2022/7
N2 - 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.
AB - 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.
KW - Convalescent plasma
KW - COVID-19
KW - Human hyperimmune immunoglobulins
KW - Passive immunotherapy
KW - SARS-CoV-2
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U2 - 10.1016/j.tmrv.2022.06.001
DO - 10.1016/j.tmrv.2022.06.001
M3 - Article
C2 - 35879213
AN - SCOPUS:85134746068
SN - 0887-7963
VL - 36
SP - 125
EP - 132
JO - Transfusion Medicine Reviews
JF - Transfusion Medicine Reviews
IS - 3
ER -
