タカギ　リヨウ   Takagi Riyou   高木　亮    所属   医学研究科 医学研究科 (医学部医学科をご参照ください)    職種   助教
論文種別	その他
言語種別	英語
査読の有無	査読あり
表題	Lessons learned from contamination with endotoxin originated from the supplement in the cell culture medium.
掲載誌名	正式名：Regenerative therapy 略　 称：Regen Ther ISSNコード：23523204/23523204
掲載区分	国外
巻・号・頁	27,pp.230-233
著者・共著者	UEHARA Koaki†, OSHIRO Eriko, OCHIAI Atsushi, TAKAGI Ryo, YAMATO Masayuki, KATO Atsunaga*
発行年月	2024/12
概要	INTRODUCTION:Endotoxin is a typical pyrogen derived from the outer membrane of Gram-negative bacteria. In fabricating cell-based medicinal products, it is necessary to control endotoxin in the process and the products. In the quality control tests of our clinical study, endotoxin concentration in the culture supernatant of autologous oral mucosal epithelial cell sheets exceeded the criterion value. Therefore, endotoxin measurements were conducted to clarify the cause of the endotoxin contamination.METHODS:The reagents used to prepare the culture medium, the unused culture medium, and the culture supernatants were diluted with pure water. Endotoxin concentrations in the diluted samples were measured.RESULTS:Endotoxin was detected in both the unused culture medium and the culture supernatant of the epithelial cell sheets at higher concentrations than the criterion value. Therefore, endotoxin concentrations in the reagents used to prepare the culture medium were measured and were found to be below the criterion value, except for cholera toxin. On the other hand, three lots of cholera toxin products were used for the measurement, and the endotoxin concentrations were higher than the criterion value. The results indicate that the endotoxin contamination is caused by the cholera toxin product.CONCLUSIONS:To prevent endotoxin contamination in cell-based medicinal products, endotoxin concentrations in reagents used for the fabrication should be measured in the facility conducting clinical research or confirmed by an adequate certificate of analysis from the manufacturers of the reagents.
DOI	10.1016/j.reth.2024.03.022
PMID	38596824