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Cited by 286Blood transfusion and managementProtein purification and stabilityBlood donation and transfusion practices

Modern Plasma Fractionation

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Burnouf, Thierry·2007·Transfusion Medicine Reviews
DOI 10.1016/j.tmrv.2006.11.001PMC PMC7125842
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Abstract

Protein products fractionated from human plasma are an essential class of therapeutics used, often as the only available option, in the prevention, management, and treatment of life-threatening conditions resulting from trauma, congenital deficiencies, immunologic disorders, or infections. Modern plasma product production technology remains largely based on the ethanol fractionation process, but much has evolved in the last few years to improve product purity, to enhance the recovery of immunoglobulin G, and to isolate new plasma proteins, such as alpha1-protease inhibitor, von Willebrand factor, and protein C. Because of the human origin of the starting material and the pooling of 10,000 to 50,000 donations required for industrial processing, the major risk associated to plasma products is the transmission of blood-borne infectious agents. A complete set of measures--and, most particularly, the use of dedicated viral inactivation and removal treatments--has been implemented throughout the production chain of fractionated plasma products over the last 20 years to ensure optimal safety, in particular, and not exclusively, against HIV, hepatitis B virus, and hepatitis C virus. In this review, we summarize the practices of the modern plasma fractionation industry from the collection of the raw plasma material to the industrial manufacture of fractionated products. We describe the quality requirements of plasma for fractionation and the various treatments applied for the inactivation and removal of blood-borne infectious agents and provide examples of methods used for the purification of the various classes of plasma protein therapies. We also highlight aspects of the good manufacturing practices and the regulatory environment that govern the whole chain of production. In a regulated and professional environment, fractionated plasma products manufactured by modern processes are certainly among the lowest-risk therapeutic biological products in use today.

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  • To ensure that current plasma-derived, vaccine, and recombinant biotherapeutics are safe, complementary safety strategies to reduce the risk of virus contamination were developed and implemented.

    “To ensure that current plasmaderived, vaccine, and recombinant biotherapeutics are safe, complementary safety strategies to reduce the risk of virus contamination were developed and implemented [9][10][11] .”

    From Viral contamination in biologic manufacture and implications for emerging therapies (2020) · cites this paper as [11]

    The “Testing of Pathogenic Agents” section (page unavailable) describes complementary safeguards for plasma-derived products, and “Core Viral Reduction Methods” describes implemented viral inactivation and removal steps. The cited paper does not establish that these strategies were developed and implemented for vaccines or recombinant biotherapeutics. (LLM, conf=0.88)

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Authors
Burnouf, T.
Corresponding author
Burnouf, Thierry
ORCID
Burnouf, Thierry
Venue
Transfusion Medicine Reviews
Publisher
Elsevier BV
Published
2007-04
Volume
21
Issue
2
Pages
101-117
ISSN
0887-7963 (ISSN-L)
DOI
10.1016/j.tmrv.2006.11.001
PMC
PMC7125842
OpenAlex
W2024630021
Cited by
286
References
0
Citations by year
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FWCI
1.19
Type
journal article
Language
en
Open access
Licence
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations
  • Transfusion Medicine Reviews (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Biochemistry › Blood transfusion and management
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Protein purification and stability
  • Social Sciences › Business, Management and Accounting › Management of Technology and Innovation › Blood donation and transfusion practices
Keywords
plasma fractionation, ethanol fractionation, alpha 1-proteinase inhibitor, von Willebrand factor, protein C, blood-borne virus transmission, virus inactivation, HIV, hepatitis B virus, hepatitis C virus, plasma protein purification, good manufacturing practices, regulatory oversight
MeSH terms
Blood Donors, Blood Proteins, Communicable Disease Control, Humans, Plasma, Blood Component Transfusion, Donor Selection

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