Related Experiment Video
Updated: Mar 23, 2026

A Nonviral Approach to Generate Transient Chimeric Antigen Receptor T Cells Using mRNA for Cancer Immunotherapy
Published on: February 21, 2025
ATMPs for Cancer Immunotherapy: A Regulatory Overview
1Department of Cell Biology and Neurosciences, Istituto Superiore di Sanità, 299, Viale Regina Elena, Roma, Italy. mariacristina.galli@iss.it.
Abstract:
This chapter discusses European regulatory requirements for development of advanced therapy medicinal products (ATMP) for cancer immunotherapy approaches, describing the framework for clinical trials and for marketing authorization.Regulatory critical issues and challenges for developing ATMP are also discussed, with focus on potency determination, long-term follow-up, comparability, and insertional mutagenesis issues. Some of the most critical features of GMP application to ATMP are also described.
Related Concept Videos
Tumor Immunotherapy
Cancer Vaccines
Cancer vaccines come in two categories: preventive (prophylactic) and treatment (active). Preventive vaccines, such as the Human Papillomavirus (HPV) vaccine, protect against viruses that cause certain...
Targeted Cancer Therapies
There are several types of targeted therapies against...
Targeted Cancer Therapies
Cancer Therapies
However, cancer treatments can pose several challenges, as therapies used to kill cancer cells are generally also toxic to normal cells. Moreover, cancer cells mutate rapidly and can develop resistance to chemical agents or radiation therapy. Besides, all types of cancer cells may not respond to the same therapy. Some cancer cells respond to one...
Cancer Therapies

