Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

Tumor Immunotherapy01:27

Tumor Immunotherapy

2.1K
Immunotherapy is a treatment that boosts or manipulates the immune system to fight diseases, including cancer. For instance, by stimulating an immune response through vaccinations against viruses that cause cancers, like hepatitis B virus and human papillomavirus, these diseases can be prevented. Nonetheless, some cancer cells can avoid the immune system due to their rapid mutation and division. The immune response to many cancers involves three phases: elimination, equilibrium, and escape.
2.1K
Cancer Vaccines01:30

Cancer Vaccines

1.3K
Cancer treatment vaccines are a rapidly evolving field that offers a promising approach to immunotherapy. Unlike traditional vaccines that prevent diseases, cancer treatment vaccines are designed to treat existing cancers by stimulating the immune system to recognize and attack cancer cells.
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...
1.3K
Targeted Cancer Therapies02:57

Targeted Cancer Therapies

9.1K
The targeted cancer therapies, also known as “molecular targeted therapies,” take advantage of the molecular and genetic differences between the cancer cells and the normal cells. It needs a thorough understanding of the cancer cells to develop drugs that can target specific molecular aspects that drive the growth, progression, and spread of cancer cells without affecting the growth and survival of other normal cells in the body.
There are several types of targeted therapies against...
9.1K
Targeted Cancer Therapies02:57

Targeted Cancer Therapies

1.7K
1.7K
Cancer Therapies02:49

Cancer Therapies

10.6K
Cancer therapies are various modes of treatment, such as surgery, radiation therapy, and chemotherapy that are administered to cancer patients.
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...
10.6K
Cancer Therapies02:49

Cancer Therapies

3.0K
3.0K

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Breastfeeding promotion and support: a quality improvement study.

Annali dell'Istituto superiore di sanita·2021
Same author

Breastfeeding pathologies: analysis of prevalence, risk and protective factors.

Acta bio-medica : Atenei Parmensis·2019
Same author

Preface.

Advances in experimental medicine and biology·2015
Same author

Clinical development of gene therapy needs a tailored approach: a regulatory perspective from the European Union.

Human gene therapy. Clinical development·2014
Same author

The committee for advanced therapies' of the European Medicines Agency reflection paper on management of clinical risks deriving from insertional mutagenesis.

Human gene therapy. Clinical development·2013
Same author

Long-term follow-up of cancer patients treated with gene therapy medicinal products.

The journal of gene medicine·2012
Same journal

Nanotechnology-Stem Cell Strategies in 3D Glioblastoma Organoid: Targeting Glioma Stem Cells Within a Complex Tumor Microenvironment.

Methods in molecular biology (Clifton, N.J.)·2026
Same journal

Mapping the 3D Chromosome Organization of a Biosynthetic Gene Cluster by Capture Hi-C (CHi-C).

Methods in molecular biology (Clifton, N.J.)·2026
Same journal

Mapping the 3D Chromosome Organization of Streptomyces by Hi-C.

Methods in molecular biology (Clifton, N.J.)·2026
Same journal

CUT&Tag Epigenomic Profiling of Biosynthetic Gene Clusters in Arabidopsis thaliana.

Methods in molecular biology (Clifton, N.J.)·2026
Same journal

Rhizobium rhizogenes-Mediated Hairy Root Transformation Protocol for Lotus japonicus and Other Legumes.

Methods in molecular biology (Clifton, N.J.)·2026
Same journal

Characterization of Bioactive Saponins from Sea Cucumbers.

Methods in molecular biology (Clifton, N.J.)·2026
See all related articles

Related Experiment Video

Updated: Mar 23, 2026

A Nonviral Approach to Generate Transient Chimeric Antigen Receptor T Cells Using mRNA for Cancer Immunotherapy
09:56

A Nonviral Approach to Generate Transient Chimeric Antigen Receptor T Cells Using mRNA for Cancer Immunotherapy

Published on: February 21, 2025

1.5K

ATMPs for Cancer Immunotherapy: A Regulatory Overview.

Maria Cristina Galli1

  • 1Department of Cell Biology and Neurosciences, Istituto Superiore di Sanità, 299, Viale Regina Elena, Roma, Italy. mariacristina.galli@iss.it.

Methods in Molecular Biology (Clifton, N.J.)
|April 2, 2016
PubMed
Summary
This summary is machine-generated.

This chapter outlines European regulatory pathways for advanced therapy medicinal products (ATMPs) in cancer immunotherapy. It addresses critical challenges in development, clinical trials, and marketing authorization for these innovative treatments.

Keywords:
Advanced therapy medicinal productsCancer immunotherapyClinical trialsEuropean regulationsTranslation

More Related Videos

Paramyxoviruses for Tumor-targeted Immunomodulation: Design and Evaluation Ex Vivo
12:42

Paramyxoviruses for Tumor-targeted Immunomodulation: Design and Evaluation Ex Vivo

Published on: January 7, 2019

10.4K
Analysis of Human T Cell Activity in an Allogeneic Co-Culture Setting of Pre-Treated Tumor Cells
09:04

Analysis of Human T Cell Activity in an Allogeneic Co-Culture Setting of Pre-Treated Tumor Cells

Published on: March 7, 2025

1.9K

Related Experiment Videos

Last Updated: Mar 23, 2026

A Nonviral Approach to Generate Transient Chimeric Antigen Receptor T Cells Using mRNA for Cancer Immunotherapy
09:56

A Nonviral Approach to Generate Transient Chimeric Antigen Receptor T Cells Using mRNA for Cancer Immunotherapy

Published on: February 21, 2025

1.5K
Paramyxoviruses for Tumor-targeted Immunomodulation: Design and Evaluation Ex Vivo
12:42

Paramyxoviruses for Tumor-targeted Immunomodulation: Design and Evaluation Ex Vivo

Published on: January 7, 2019

10.4K
Analysis of Human T Cell Activity in an Allogeneic Co-Culture Setting of Pre-Treated Tumor Cells
09:04

Analysis of Human T Cell Activity in an Allogeneic Co-Culture Setting of Pre-Treated Tumor Cells

Published on: March 7, 2025

1.9K

Area of Science:

  • Biotechnology
  • Oncology
  • Regulatory Science

Background:

  • Advanced therapy medicinal products (ATMPs) offer novel cancer immunotherapy strategies.
  • Navigating the regulatory landscape in Europe is crucial for ATMP development.
  • Existing frameworks require adaptation for these complex biological products.

Purpose of the Study:

  • To delineate European regulatory requirements for ATMP development in cancer immunotherapy.
  • To identify and discuss critical challenges and issues in ATMP clinical trials and marketing authorization.
  • To highlight essential aspects of Good Manufacturing Practice (GMP) for ATMPs.

Main Methods:

  • Review of European Medicines Agency (EMA) guidelines and regulations.
  • Analysis of the regulatory framework for clinical trials and marketing authorization.
  • Discussion of specific technical and regulatory challenges.

Main Results:

  • A comprehensive overview of the regulatory framework for ATMPs in Europe.
  • Identification of key challenges including potency, long-term follow-up, comparability, and insertional mutagenesis.
  • Emphasis on critical GMP considerations for ATMP manufacturing.

Conclusions:

  • Successful development of ATMPs for cancer immunotherapy requires a thorough understanding of European regulations.
  • Addressing specific challenges in potency, follow-up, comparability, and safety is paramount.
  • Adherence to stringent GMP standards is essential for ensuring product quality and patient safety.