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Production and Quality Assurance of Human Polyclonal Hyperimmune Immunoglobulins Against SARS-CoV-2.
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.
  • Burnouf T; College of Biomedical Engineering, Graduate Institute of Biomedical Materials and Tissue Engineering, Taipei Medical University, Taipei, Taiwan; International PhD Program in Biomedical Engineering, College of Biomedical Engineering, Taipei Medical University, Taipei, Taiwan. Electronic address: thbu
  • Gathof B; Department of Transfusion Medicine, University Hospital of Cologne, Köln, Germany. Electronic address: Birgit.Gathof@uk-koeln.de.
  • Bloch EM; Division of Transfusion Medicine, Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
  • Bazin R; Héma-Québec, Medical Affairs and Innovation, Québec, Canada.
  • de Angelis V; National Blood Centre, Italian National Institute of Health, Rome, Italy.
  • Patidar GK; Department of Transfusion Medicine, All India Institute of Medical Sciences, New Delhi, India.
  • Rastvorceva RMG; Institute for Transfusion Medicine of RNM, Skopje, North Macedonia; Faculty of Medical Sciences, University Goce Delcev, Stip, North Macedonia.
  • Oreh A; Department of Planning, Research and Statistics, National Blood Service Commission, Federal Ministry of Health, Abuja, Nigeria.
  • Goel R; Division of Transfusion Medicine, Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA; Division of Hematology/Oncology, Simmons Cancer Institute at SIU School of Medicine and ImpactLife Blood Center, Springfield, IL, USA.
  • Rahimi-Levene N; Blood Bank, Shamir Medical Center, Assaf Harofeh MC, Zerifin, Israel.
  • Hindawi S; Haematology Department, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia.
  • Al-Riyami AZ; Department of Hematology, Sultan Qaboos University Hospital, Muscat, Sultanate of Oman.
  • So-Osman C; Department of Haematology, Erasmus Medical Centre, Rotterdam, The Netherlands; Unit Transfusion Medicine, Sanquin Blood Supply Foundation, Amsterdam, The Netherlands.
Transfus Med Rev ; 36(3): 125-132, 2022 07.
Article in English | MEDLINE | ID: covidwho-1882561
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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Experimental Studies Limits: Humans Language: English Journal: Transfus Med Rev Journal subject: Hematology Year: 2022 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Experimental Studies Limits: Humans Language: English Journal: Transfus Med Rev Journal subject: Hematology Year: 2022 Document Type: Article