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 , ISBT COVID-19 Convalescent Plasma Working Group (see the Appendix)
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Production and Quality Assurance of Human Polyclonal Hyperimmune Immunoglobulins Against SARS-CoV-2
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.
期刊介绍：
Transfusion Medicine Reviews provides an international forum in English for the publication of scholarly work devoted to the various sub-disciplines that comprise Transfusion Medicine including hemostasis and thrombosis and cellular therapies. The scope of the journal encompasses basic science, practical aspects, laboratory developments, clinical indications, and adverse effects.
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