Shimadzu Review Vol.80[3・4](2023)
Diagnostics

SPECIALLY COLLECTED PAPERS

Development of Safety Test Kits and Related Technologies for Safety Testing in Cell-Based Industries

by Risa Yanagida, Akari TeramotoHitomi OtakeMitsuaki KashidaYuri MashikoKei Tominaga, Ph.D.Toshihiro IiYuichi Oku, Ph.D.

Shimadzu Review 80[3・4] (2023)

Abstract

Because regenerative medicine uses cells cultured in vitro, the therapeutic products created with these cells must test negative for microbial and viral contamination to ensure their safety. However, unlike other pharmaceuticals, because these products can be difficult to store long-term they require rapid safety tests that provide quick results. Recognizing this need, we have already commercialized two safety test kits (Myco Finder and VirFinder) that use the nucleic acid amplification test (NAT) method, which offers rapid results and are currently developing another kit. This article describes the features, usage, and presents performance data on these safety test kits.


Shimadzu Diagnostics Corporation, Ibaraki, Japan

*The information contained in Shimadzu Review has not been modified since the original publication date. Please be aware that in some cases, products mentioned within the articles are no longer available.