Development of a digital analysis system for a novel 3D culture-based colony formation to detect malignantly transformed cells in human cell-based therapeutic products
Finally, by systematizing the digital analysis system for the LACF assay (D-LACF assay), which streamlines the overall workflow from the performance evaluation of the test method to product testing and result interpretation, the limitations of the conventional soft agar-based D-SACF assay were addressed, and its practicality and utility were enhanced. This <i>in vitro</i> evaluation system is expected to provide a promising approach for improving the quality and safety of hCTPs.
Authors
- Ryuji Kato (ORCID: https://orcid.org/0000-0003-3604-9407)
- Rumi Sawada
- Satoshi Yasuda (ORCID: https://orcid.org/0000-0002-1011-0815)
- Yoji Sato (ORCID: https://orcid.org/0000-0002-9889-1272)
- Shinji Kusakawa (ORCID: https://orcid.org/0009-0000-7720-9345)
- Yang Ting-shu (ORCID: https://orcid.org/0009-0007-7820-4360)
Institutions
- National Institute of Health Sciences (JP)
- Tokai National Higher Education and Research System
- Nagoya University (JP)
Publication Details
- Journal
- Regenerative Therapy
- Published
- 2025-12-19
- DOI
- https://doi.org/10.1016/j.reth.2025.101052
- Primary Topic
- Viral Infectious Diseases and Gene Expression in Insects
- Type
- article
- Field-Weighted Citation Impact
- 0.00