Domestic and International Trends in Non-Clinical Safety Evaluation of Cell Therapy Products

DOI
  • SATO Yoji
    Division of Cell-Based Therapeutic Products, National Institute of Health Sciences

Bibliographic Information

Other Title
  • 細胞加工製品の非臨床安全性評価に関する国内外の状況

Abstract

<p>Cell therapy products (CTPs) are a new pharmaceutical modality containing living cells. The risk of tumorigenesis derived from cells in the product is one of the major concerns specific to CTPs, and appropriate test methods must be developed as needed. A variety of highly sensitive detection methods for tumorigenic cells as impurities of CTPs have been developed in Japan, some of which have been validated through a public-private joint research (MEASURE). The need for global consensus on the tumorigenicity assessment of CTPs is also discussed at an international consortium (HESI CT-TRACS). </p>

Journal

Details 詳細情報について

  • CRID
    1390570486221109760
  • NII Article ID
    130008073896
  • DOI
    10.14869/toxpt.48.1.0_s27-1
  • Text Lang
    ja
  • Data Source
    • JaLC
    • CiNii Articles
  • Abstract License Flag
    Disallowed

Report a problem

Back to top