Standardized pyrogen testing of medical products with the bacterial endotoxin test (BET) as a substitute for rabbit Pyrogen testing (RPT): A scoping review.

Autor: Spoladore J; Post-Graduation Program in Science and Biotechnology, Fluminense Federal University, Niteroi, Brazil., Gimenes I; Post-Graduation Program in Science and Biotechnology, Fluminense Federal University, Niteroi, Brazil., Bachinski R; Post-Graduation Program in Science and Biotechnology, Fluminense Federal University, Niteroi, Brazil; 1R Institute, Rio de Janeiro, Brazil., Negherbon JP; The John's Hopkins Bloomberg School of Public Health, Center for Alternatives to Animal Testing, Baltimore, MD, USA., Hartung T; The John's Hopkins Bloomberg School of Public Health, Center for Alternatives to Animal Testing, Baltimore, MD, USA., Granjeiro JM; National Institute of Metrology, Quality, and Technology (INMETRO), Rio de Janeiro, Brazil., Alves GG; 1R Institute, Rio de Janeiro, Brazil; Cell and Molecular Biology Department, Institute of Biology, Fluminense Federal University, Niteroi, Brazil. Electronic address: gutemberg_alves@id.uff.br.
Jazyk: angličtina
Zdroj: Toxicology in vitro : an international journal published in association with BIBRA [Toxicol In Vitro] 2021 Aug; Vol. 74, pp. 105160. Date of Electronic Publication: 2021 Apr 06.
DOI: 10.1016/j.tiv.2021.105160
Abstrakt: The Bacterial Endotoxin Test (BET) is a method for exclusion of endotoxin-related pyrogen contamination in pharmaceutical products, as an alternative to the Rabbit Pyrogen Test (RPT). However, BET does not detect a broad range of biologically relevant pyrogens, and interferences can limit its practical use for different medical products. This work aimed to scope the evidence in the scientific literature for case-by-case validity assessments of BET in different uses for medical products. A search strategy was conducted in PubMed, Scopus, and Web of Science in April 2020, according to the PRISMA-ScR statement. Twenty-two references were included, evaluating medical products for endotoxin contamination through both BET and RPT according to standardized protocols. A critical appraisal was performed through ToxRTool, followed by data extraction and qualitative synthesis of outcomes and methodological issues. Four classes of products assessed by BET were identified, including nanoparticles, drugs, blood and biological products. A considerable variation was observed on the BET methods used. Collectively, the evidence indicates different factors influencing the outcome of BET, including the chemical nature of samples that may cause interference depending on the selected method. While some applications to medical products appear adequate, others, such as nanoparticles, may require the use of different in vitro pyrogen testing methods, reinforcing the need for case-by-case validation for each BET method and type of medical product.
(Copyright © 2021 Elsevier Ltd. All rights reserved.)
Databáze: MEDLINE
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