Nonclinical Evaluation Studies of Cellular and Gene Therapy Products
Strategies, Models, and Regulatory Frameworks
- 1st Edition - October 1, 2026
- Latest edition
- Editors: Quanjun Wang, Qingli Wang, Xingchao Geng
- Language: English
Nonclinical Evaluation Studies of Cellular and Gene Therapy Products: Strategies, Models, and Regulatory Frameworks systematically explores the nonclinical evaluation of Cell a… Read more
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Description
Description
Key features
Key features
- Includes definitions, regulatory policies (US, EU, China), and quality control requirements
- Provides in-depth coverage of humanized animal models, organ-on-chip systems, and 3D bioprinted tissues for toxicity screening
- Covers evaluation strategies for mRNA drugs, exosome-based therapies, and red blood cell-mediated drug delivery
- Includes case studies: FDA-approved CRISPR therapies, CAR-T safety assessments, and lessons from failed trials
Readership
Readership
Table of contents
Table of contents
2. Safety risks of cell and gene therapy products
3. Regulatory frameworks for cell and gene therapy products
4. Quality control of cell and gene therapy products
5. Nonclinical toxicology studies
6. Advances in in vivo animal models for evaluation
7. Organoid and organ-on-chip models for evaluation
8. Evaluation of delivery systems
9. Immunogenicity assessment
10. Pharmacokinetics studies and evaluation
11. Tumorigenicity/oncogenicity assessment
12. Integration site analysis and off-target assessment
13. Nonclinical evaluation of stem cell products
14. Nonclinical evaluation of car-t cell products
15. Nonclinical evaluation of oncolytic viruses
16. Nonclinical evaluation of gene editing products
17. Nonclinical evaluation of nucleic acid drugs
18. Nonclinical evaluation of extracellular vesicle therapies
19. Nonclinical evaluation of red cell therapeutics
20. Nonclinical evaluation of combination therapies
21. On-site GLP inspection for registration Abbreviations
Product details
Product details
- Edition: 1
- Latest edition
- Published: October 1, 2026
- Language: English
About the editors
About the editors
QW
Quanjun Wang
Dr Quanjun Wang is CEO and Chief Scientist of the Safe Medical Research Institute and Vice President of the Suzhou Institute of Biomedical Engineering and Technology, Chinese Academy of Sciences. He is a Distinguished Professor at the Hefei Institutes of Physical Science, Chinese Academy of Sciences; Adjunct Doctoral Supervisor, School of Pharmacy, East China Normal University
Dr Wang has over 20 years of experience in innovative drug R&D and nonclinical safety evaluation. He has published 140+ peer-reviewed papers and authored/co-authored eight monographs in toxicology and regulatory science. He golds 20+ patents in drug evaluation methodologiesQW
Qingli Wang
Dr Qingli Wang is Chief Pharmacist and Senior Reviewer at the Center for Drug Evaluation (CDE), National Medical Products Administration (NMPA). Dr. Wang joined the CDE in 2002 and has since specialized in the evaluation of drug safety studies. Currently serving as Director of the Department of Pharmacology and Toxicology at the CDE, he leads technical reviews for pharmacological and toxicological studies of drugs and spearheads the development of China’s technical guidance system for non-clinical drug research.
Concurrently, he holds the position of Chair of the Drug Toxicology Committee at the Chinese Pharmacological SocietyXG