Can I read Evaluation of the Reproducibility and Positive Controls of Cellular Immortality Test for the Detection of Immortalized Cellular Impurities in Human Cell-processed Therapeutic Products on EtoBox?

Evaluation of the Reproducibility and Positive Controls of Cellular Immortality Test for the Detection of Immortalized Cellular Impurities in Human Cell-processed Therapeutic Products by Takamasa Hirai; Ken Kono; Shinji Kusakawa; Satoshi Yasuda; Rumi Sawada; Akihiko Morishita; Shinko Hata; Atsushi Wakita; Takayasu Kageyama; Ryo Takahashi; Sono Watanabe; Norihiko Shiraishi; Yoji Sato is a Medicine article available to read on EtoBox.

What is Evaluation of the Reproducibility and Positive Controls of Cellular Immortality Test for the Detection of Immortalized Cellular Impurities in Human Cell-processed Therapeutic Products about?

## Introduction Contamination of human cell-processed therapeutic products (hCTPs) with tumorigenic/immortalized cellular impurities is a major concern in the manufacturing and quality control of hCTPs. The cellular immortality test based on cell growth analysis is a method for detecting tumorigenic/immortalized cellular impurities in hCTPs. However, the performance of the cellular immortality test has not yet been well characterized. In this study, we examined the reproducibility of the cellular immortality test in detecting HeLa cells as a model of tumorigenic cellular impurities, as well as the applicability of other models of cellular impurities with different tumorigenicity to the cellular immortality test. ## Methods Using HeLa cells as a model for cellular impurities, we measured the growth rate of human mesenchymal stem cells (hMSCs) supplemented with HeLa cells at concentrations ranging from 0.01 to 0.0001% at each passage in three laboratories and evaluated the reproducibility of the detection of immortalized cellular impurities. In addition, HEK293 cells (another immortalized cell line) and MRC-5 cells (a non-immortalized cell line) were employed as cellular impurity mod

Who reads Evaluation of the Reproducibility and Positive Controls of Cellular Immortality Test for the Detection of Immortalized Cellular Impurities in Human Cell-processed Therapeutic Products?

Author

Takamasa Hirai; Ken Kono; Shinji Kusakawa; Satoshi Yasuda; Rumi Sawada; Akihiko Morishita; Shinko Hata; Atsushi Wakita; Takayasu Kageyama; Ryo Takahashi; Sono Watanabe; Norihiko Shiraishi; Yoji Sato

Publisher

Elsevier BV

Published

2022

Language

EN

Field

Medicine (Health Sciences)