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Cited by 19Microbial Inactivation MethodsPhotodynamic Therapy Research StudiesInfection Control in Healthcare

Evaluating ultraviolet sensitivity of adventitious agents in biopharmaceutical manufacturing

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Meunier, Sarah M, Sasges, Michael R, Aucoin, Marc G·2017·Journal of Industrial Microbiology and Biotechnology
DOI 10.1007/s10295-017-1917-0PMC PMC7087614
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Abstract

Incidents of contamination in biopharmaceutical production have highlighted the need to apply alternative or supplementary disinfection techniques. Ultraviolet (UV) irradiation is a well-established method for inactivating a broad range of microorganisms, and is therefore a good candidate as an orthogonal technique for disinfection. To apply UV as a safeguard against adventitious agents, the UV sensitivity of these target agents must be known so that the appropriate dose of UV may be applied to achieve the desired level of inactivation. This document compiles and reviews experimentally derived 254 nm sensitivities of organisms relevant to biopharmaceutical production. In general, different researchers have found similar sensitivity values despite a lack of uniformity in experimental design or standardized quantification techniques. Still, the lack of consistent methodologies has led to suspicious UV susceptibilities in certain instances, justifying the need to create a robust collection of sensitivity values that can be used in the design and sizing of UV systems for the inactivation of adventitious agents.

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  • At the end of Q3 2019, more than 1,052 advanced therapy medicinal products (ATMPs) were being tested in phase I-III clinical trials and several cell and gene therapies had received regulatory approval.

    “At the end of Q3, 2019, more than 1,052 advanced therapy medicinal products (ATMPs) were being tested in phase I-III clinical trials (https://alliancerm.org/publication/q3-2019-data-report/) and several cell 45 and gene 46 therapies had received regulatory approval.”

    From Viral contamination in biologic manufacture and implications for emerging therapies (2020) · cites this paper as [46]

    The citation is attached to the statement that cell therapies had received regulatory approval; the Q3 2019 trial count is attributed to a separate URL. The Introduction and Discussion and conclusions address contamination and UV disinfection in biopharmaceutical manufacturing, not approvals of cell therapies. Searches for approved cell therapies and regulatory approval found no supporting passage in our copy. (LLM, conf=0.76)

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Authors
Meunier, S. M., Sasges, M. R., & Aucoin, M. G.
Affiliations
  • University of Waterloo (CA)
  • Trojan Technologies (Canada) (CA)
Corresponding author
Sasges, Michael R
ORCID
Venue
Journal of Industrial Microbiology and Biotechnology
Publisher
Oxford University Press (OUP)
Published
2017-06-01
Volume
44
Issue
6
Pages
893-909
ISSN
  • 1367-5435 (ISSN-L)
  • 1476-5535
DOI
10.1007/s10295-017-1917-0
PMC
PMC7087614
OpenAlex
W2593546077
Cited by
19
References
2
Citations by year
2026: 1 · 2025: 1 · 2023: 2 · 2022: 1 · 2021: 4 · 2020: 4 · 2019: 2 · 2018: 3 · 2017: 1
FWCI
0.38
Type
journal article
Language
en
Open access
Licence
Locations
  • Journal of Industrial Microbiology & Biotechnology (publishedVersion)
  • Europe PMC (PubMed Central) (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • Mitacs
  • Canadian Network for Research and Innovation in Machining Technology, Natural Sciences and Engineering Research Council of Canada (EGP2 460753-13, CRDTJ48483-2015)
Topics
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Biotechnology › Microbial Inactivation Methods
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Photodynamic Therapy Research Studies
  • Health Sciences › Medicine › Infectious Diseases › Infection Control in Healthcare
Keywords
UV irradiation, UV sensitivity, 254 nm, adventitious agents, biopharmaceutical manufacturing, disinfection, microbial inactivation, contamination control, UV dose
MeSH terms
Bacteria, Biopharmaceutics, Disinfection, Radiation Tolerance, Ultraviolet Rays, Viruses

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