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

IF 2.7 2区医学 Q2 HEMATOLOGY

Transfusion Medicine Reviews Pub Date : 2022-07-01 DOI:10.1016/j.tmrv.2022.06.001

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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引用次数: 8

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.

查看原文本刊更多论文

人抗SARS-CoV-2多克隆高免疫免疫球蛋白的制备及质量保证

2019冠状病毒病(COVID-19)大流行凸显了高效价恢复期血浆(CCP)早期被动多克隆免疫治疗的潜在治疗价值。人多克隆高免疫球蛋白(HIG)与CCP相比有几个优势。与CCP不同，HIG可以提供标准化和可控制的抗体含量。它也受到强大的病原体减少，使其病毒安全，并通过技术纯化，证明保持免疫球蛋白中和能力和Fc片段完整性。本文件概述了收集和检测富含抗严重急性呼吸道冠状病毒2 (SARS-CoV-2)抗体的血浆及其工业分离的现行做法和指南，以生产质量有保证和安全的HIG。还考虑到在低收入和中等收入国家生产HIG制剂。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Transfusion Medicine Reviews 医学-血液学

CiteScore

11.60

自引率

0.00%

发文量

审稿时长

21 days

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.