Review: High temperature short time treatment of cell culture media and feed solutions to mitigate adventitious viral contamination in the biopharmaceutical industry

Events of viral contaminations occurring during the production of biopharmaceuticals have been publicly reported by the biopharmaceutical industry. Upstream raw materials were often identified as the potential source of contamination. Viral contamination risk can be mitigated by inactivating or elim...

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Bibliographic Details
Published in:Biotechnology progress 2021-05, Vol.37 (3), p.e3117-n/a
Main Authors: Djemal, Leïla, Fournier, Clemence, Hagen, Joerg, Kolmar, Harald, Deparis, Véronique
Format: Article
Language:English
Subjects:
Animals
Biopharmaceuticals
Cell culture
Cell Culture Techniques - methods
Cell Culture Techniques - standards
CHO Cells
Contamination
Cricetinae
Cricetulus
Culture media
Culture Media - chemistry
Culture Media - standards
Deactivation
Drug Contamination - prevention & control
Drug Industry
Filterability
flash pasteurization
Gamma rays
HEK293 Cells
High temperature
high temperature short time
Hot Temperature
Humans
Inactivation
Irradiation
Media
Metabolism
Nanofiltration
Nanotechnology
Pasteurization - methods
precipitation
Raw materials
Technology
Ultraviolet radiation
virus
Virus Inactivation - radiation effects
Viruses
Viruses - pathogenicity
γ Radiation
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Summary:Events of viral contaminations occurring during the production of biopharmaceuticals have been publicly reported by the biopharmaceutical industry. Upstream raw materials were often identified as the potential source of contamination. Viral contamination risk can be mitigated by inactivating or eliminating potential viruses of cell culture media and feed solutions. Different methods can be used alone or in combination on raw materials, cell culture media, or feed solutions such as viral inactivation technologies consisting mainly of high temperature short time, ultraviolet irradiation, and gamma radiation technologies or such as viral removal technology for instance nanofiltration. The aim of this review is to present the principle, the advantages, and the challenges of high temperature short time (HTST) technology. Here, we reviewed effectiveness of HTST treatment and its impact on media (filterability of media, degradation of components), on process performance (cell growth, cell metabolism, productivity), and product quality based on knowledge shared in the literature.
ISSN:8756-7938
1520-6033
DOI:10.1002/btpr.3117