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 standa...

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Detalles Bibliográficos
Autores principales: Burnouf, Thierry, Gathof, Birgit, Bloch, Evan M., Bazin, Renée, de Angelis, Vincenzo, Patidar, Gopal Kumar, Rastvorceva, Rada M. Grubovic, Oreh, Adaeze, Goel, Ruchika, Rahimi-Levene, Naomi, Hindawi, Salwa, Al-Riyami, Arwa Z., So-Osman, Cynthia
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier Inc. 2022
Materias:
Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9183240/
https://www.ncbi.nlm.nih.gov/pubmed/35879213
http://dx.doi.org/10.1016/j.tmrv.2022.06.001
Descripción
Sumario: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.

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