Abstract

Human plasma-derived medicinal products and snake antivenom immunoglobulins are unique and complex therapeutic protein products. Human plasma products are obtained by fractionating large pools of plasma collected from blood plasma donors. They comprise a wide range of protein products, including polyvalent and hyperimmune immunoglobulins, coagulation factors, albumin, and various protease inhibitors that are transfused to patients affected by congenital or acquired protein deficiencies, immunological disorders, or metabolic diseases. Snake antivenoms are manufactured from pools of plasma collected from animals, typically horses, which have been immunized against snake venoms. Transfusing antivenoms is the cornerstone therapy to treat patients affected by snakebite envenoming. Over the last thirty years, much technical and regulatory evolution has been implemented to ensure that this class of biologicals meets modern quality requirements. The purpose of this review is to compare the main developments that took place in plasma production, protein fractionation, pathogen safety, quality control, preclinical and clinical studies, and regulations of these products. We also analyze whether both fields have been influencing and cross-fertilizing each other technically and in regulatory aspects to reach modern safety and efficacy standards at global levels, and how experience in the human plasma fractionation industry can further impact the manufacture of snake antivenom and that of other animal-derived antisera.

Original languageEnglish
Pages (from-to)77-86
Number of pages10
JournalToxicon
Volume146
DOIs
Publication statusPublished - May 1 2018

Fingerprint

Plasma (human)
Antivenins
Snakes
Human Development
Fractionation
Plasmas
Immunoglobulins
Animals
Proteins
Snake Venoms
Blood Coagulation Factors
Plasma sources
Pathogens
Protease Inhibitors
Quality control
Snake Bites
Safety
Immune Sera
Albumins
Protein Deficiency

Keywords

  • Antivenom
  • Envenoming
  • Fractionation
  • Immunoglobulin
  • Plasma
  • Snakebite
  • Virus safety

ASJC Scopus subject areas

  • Toxicology

Cite this

What can be learned in the snake antivenom field from the developments in human plasma derived products? / Burnouf, Thierry.

In: Toxicon, Vol. 146, 01.05.2018, p. 77-86.

Research output: Contribution to journalArticle

@article{5e0e6128b0184e2293988c2088c5755a,
title = "What can be learned in the snake antivenom field from the developments in human plasma derived products?",
abstract = "Human plasma-derived medicinal products and snake antivenom immunoglobulins are unique and complex therapeutic protein products. Human plasma products are obtained by fractionating large pools of plasma collected from blood plasma donors. They comprise a wide range of protein products, including polyvalent and hyperimmune immunoglobulins, coagulation factors, albumin, and various protease inhibitors that are transfused to patients affected by congenital or acquired protein deficiencies, immunological disorders, or metabolic diseases. Snake antivenoms are manufactured from pools of plasma collected from animals, typically horses, which have been immunized against snake venoms. Transfusing antivenoms is the cornerstone therapy to treat patients affected by snakebite envenoming. Over the last thirty years, much technical and regulatory evolution has been implemented to ensure that this class of biologicals meets modern quality requirements. The purpose of this review is to compare the main developments that took place in plasma production, protein fractionation, pathogen safety, quality control, preclinical and clinical studies, and regulations of these products. We also analyze whether both fields have been influencing and cross-fertilizing each other technically and in regulatory aspects to reach modern safety and efficacy standards at global levels, and how experience in the human plasma fractionation industry can further impact the manufacture of snake antivenom and that of other animal-derived antisera.",
keywords = "Antivenom, Envenoming, Fractionation, Immunoglobulin, Plasma, Snakebite, Virus safety",
author = "Thierry Burnouf",
year = "2018",
month = "5",
day = "1",
doi = "10.1016/j.toxicon.2018.04.002",
language = "English",
volume = "146",
pages = "77--86",
journal = "Toxicon",
issn = "0041-0101",
publisher = "Elsevier Limited",

}

TY - JOUR

T1 - What can be learned in the snake antivenom field from the developments in human plasma derived products?

AU - Burnouf, Thierry

PY - 2018/5/1

Y1 - 2018/5/1

N2 - Human plasma-derived medicinal products and snake antivenom immunoglobulins are unique and complex therapeutic protein products. Human plasma products are obtained by fractionating large pools of plasma collected from blood plasma donors. They comprise a wide range of protein products, including polyvalent and hyperimmune immunoglobulins, coagulation factors, albumin, and various protease inhibitors that are transfused to patients affected by congenital or acquired protein deficiencies, immunological disorders, or metabolic diseases. Snake antivenoms are manufactured from pools of plasma collected from animals, typically horses, which have been immunized against snake venoms. Transfusing antivenoms is the cornerstone therapy to treat patients affected by snakebite envenoming. Over the last thirty years, much technical and regulatory evolution has been implemented to ensure that this class of biologicals meets modern quality requirements. The purpose of this review is to compare the main developments that took place in plasma production, protein fractionation, pathogen safety, quality control, preclinical and clinical studies, and regulations of these products. We also analyze whether both fields have been influencing and cross-fertilizing each other technically and in regulatory aspects to reach modern safety and efficacy standards at global levels, and how experience in the human plasma fractionation industry can further impact the manufacture of snake antivenom and that of other animal-derived antisera.

AB - Human plasma-derived medicinal products and snake antivenom immunoglobulins are unique and complex therapeutic protein products. Human plasma products are obtained by fractionating large pools of plasma collected from blood plasma donors. They comprise a wide range of protein products, including polyvalent and hyperimmune immunoglobulins, coagulation factors, albumin, and various protease inhibitors that are transfused to patients affected by congenital or acquired protein deficiencies, immunological disorders, or metabolic diseases. Snake antivenoms are manufactured from pools of plasma collected from animals, typically horses, which have been immunized against snake venoms. Transfusing antivenoms is the cornerstone therapy to treat patients affected by snakebite envenoming. Over the last thirty years, much technical and regulatory evolution has been implemented to ensure that this class of biologicals meets modern quality requirements. The purpose of this review is to compare the main developments that took place in plasma production, protein fractionation, pathogen safety, quality control, preclinical and clinical studies, and regulations of these products. We also analyze whether both fields have been influencing and cross-fertilizing each other technically and in regulatory aspects to reach modern safety and efficacy standards at global levels, and how experience in the human plasma fractionation industry can further impact the manufacture of snake antivenom and that of other animal-derived antisera.

KW - Antivenom

KW - Envenoming

KW - Fractionation

KW - Immunoglobulin

KW - Plasma

KW - Snakebite

KW - Virus safety

UR - http://www.scopus.com/inward/record.url?scp=85044987183&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85044987183&partnerID=8YFLogxK

U2 - 10.1016/j.toxicon.2018.04.002

DO - 10.1016/j.toxicon.2018.04.002

M3 - Article

AN - SCOPUS:85044987183

VL - 146

SP - 77

EP - 86

JO - Toxicon

JF - Toxicon

SN - 0041-0101

ER -