Evaluation of the reproducibility and positive controls of cellular immortality test for the detection of immortalized cellular impurities in human cell-processed therapeutic products

Evaluation of the reproducibility and positive controls of cellular immortality test for the detection of immortalized cellular impurities in human cell-processed therapeutic products

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/i...

Full description

Bibliographic Details
Main Authors: 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
Format: Article
Language:English
Published: Elsevier 2022-12-01
Series:Regenerative Therapy
Subjects:
Cellular immortality test
Cell growth analysis
Cellular therapy
Tumorigenicity
Quality and safety
Online Access:http://www.sciencedirect.com/science/article/pii/S2352320422001067

Similar Items

Similar Items