Current technologies to endotoxin detection and removal for biopharmaceutical purification.
Gram-negative bacteria
biopharmaceutical
biosensors
chromatography
downstream purification
endotoxin
endotoxin detection
endotoxin removal
lipopolysaccharides
protein purification
Journal
Biotechnology and bioengineering
ISSN: 1097-0290
Titre abrégé: Biotechnol Bioeng
Pays: United States
ID NLM: 7502021
Informations de publication
Date de publication:
08 2020
08 2020
Historique:
received:
30
11
2019
revised:
20
04
2020
accepted:
22
04
2020
pubmed:
26
4
2020
medline:
11
8
2021
entrez:
26
4
2020
Statut:
ppublish
Résumé
Endotoxins are the major contributors to the pyrogenic response caused by contaminated pharmaceutical products, formulation ingredients, and medical devices. Recombinant biopharmaceutical products are manufactured using living organisms, including Gram-negative bacteria. Upon the death of a Gram-negative bacterium, endotoxins (also known as lipopolysaccharides) in the outer cell membrane are released into the lysate where they can interact with and form bonds with biomolecules, including target therapeutic compounds. Endotoxin contamination of biologic products may also occur through water, raw materials such as excipients, media, additives, sera, equipment, containers closure systems, and expression systems used in manufacturing. The manufacturing process is, therefore, in critical need of methods to reduce and remove endotoxins by monitoring raw materials and in-process intermediates at critical steps, in addition to final drug product release testing. This review paper highlights a discussion on three major topics about endotoxin detection techniques, upstream processes for the production of therapeutic molecules, and downstream processes to eliminate endotoxins during product purification. Finally, we have evaluated the effectiveness of endotoxin removal processes from a perspective of high purity and low cost.
Substances chimiques
Biological Products
0
Endotoxins
0
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, Non-P.H.S.
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
2588-2609Subventions
Organisme : U.S. Environmental Protection Agency
ID : 83996201
Pays : International
Organisme : The Missouri Soybean Merchandising Council (MSMC)
ID : 20‐447‐21
Pays : International
Informations de copyright
© 2020 Wiley Periodicals LLC.
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