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

What is Genetic Engineering?00:49

What is Genetic Engineering?

82.0K
Overview
82.0K
Gene Therapy00:59

Gene Therapy

28.3K
Gene therapy is a technique where a gene is inserted into a person’s cells to prevent or treat a serious disease. The added gene may be a healthy version of the gene that is mutated in the patient, or it could be a different gene that inactivates or compensates for the patient’s disease-causing gene. For example, in patients with severe combined immunodeficiency (SCID) due to a mutation in the gene for the enzyme adenosine deaminase, a functioning version of the gene can be...
28.3K

You might also read

Related Articles

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

Sort by
Same author

Product release assays.

Cytotherapy·2010
Same author

Are you feeling ablated?

Cytotherapy·2010
Same author

ISHAGE committees--the whole is, indeed, and in deed, greater than the sum of its parts.

Cytotherapy·2009
Same author

Debulking blood stem cell collections by density gradient centrifugation in a closed-vessel system.

Cytotherapy·2009
Same author

Influence of T cell depletion method on circulating gammadelta T cell reconstitution and potential role in the graft-versus-leukemia effect.

Cytotherapy·2009
Same author

A multicenter comparison study between the Endosafe PTS rapid-release testing system and traditional methods for detecting endotoxin in cell-therapy products.

Cytotherapy·2008
Same journal

Transcriptomic profiling of a novel gastric implantation model identifies mechanisms and pathways that drive implantation into explanted human peritoneum.

Cancer gene therapy·2026
Same journal

NCBP1 promotes the malignant progression of Wilms' tumor through stabilization of KPNA2 mRNA.

Cancer gene therapy·2026
Same journal

Reprogramming the tumor microenvironment via TFF3 targeting: a potential novel avenue to boost CAR-T cell therapy in solid tumors.

Cancer gene therapy·2026
Same journal

Hepatitis B virus-induced hepatocellular carcinoma: HBx-associated epigenetic mechanisms and therapeutic opportunities.

Cancer gene therapy·2026
Same journal

Mesenchymal stem cell-mediated delivery boosts the efficacy of suicide gene therapy based on retroviral replicating vectors in peritoneally disseminated cancer.

Cancer gene therapy·2026
Same journal

The Tumor-suppressive role of CNTNAP2 in glioma: Dual regulation of the NDN-ERK axis and M2 macrophage polarization.

Cancer gene therapy·2026
See all related articles

Related Experiment Video

Updated: Apr 18, 2026

A GMP-Compliant Procedure for the Generation of Gene-Modified T cells
06:47

A GMP-Compliant Procedure for the Generation of Gene-Modified T cells

Published on: October 6, 2023

1.1K

Manufacturing genetically modified T cells for clinical trials.

A P Gee1

  • 1Center for Cell & Gene Therapy, Baylor College of Medicine, Houston, Texas, USA.

Cancer Gene Therapy
|January 31, 2015
PubMed
Summary
This summary is machine-generated.

Manufacturing genetically modified T cells for early phase clinical trials requires understanding current Good Manufacturing Practices (cGMP). This review simplifies cGMP for new investigators, addressing key manufacturing hurdles for cellular therapies.

More Related Videos

Author Spotlight: Advancements in CAR-T Cell Manufacturing and Gene Therapy Production
06:18

Author Spotlight: Advancements in CAR-T Cell Manufacturing and Gene Therapy Production

Published on: August 18, 2023

4.0K
Clinical Application of Sleeping Beauty and Artificial Antigen Presenting Cells to Genetically Modify T Cells from Peripheral and Umbilical Cord Blood
09:29

Clinical Application of Sleeping Beauty and Artificial Antigen Presenting Cells to Genetically Modify T Cells from Peripheral and Umbilical Cord Blood

Published on: February 1, 2013

19.1K

Related Experiment Videos

Last Updated: Apr 18, 2026

A GMP-Compliant Procedure for the Generation of Gene-Modified T cells
06:47

A GMP-Compliant Procedure for the Generation of Gene-Modified T cells

Published on: October 6, 2023

1.1K
Author Spotlight: Advancements in CAR-T Cell Manufacturing and Gene Therapy Production
06:18

Author Spotlight: Advancements in CAR-T Cell Manufacturing and Gene Therapy Production

Published on: August 18, 2023

4.0K
Clinical Application of Sleeping Beauty and Artificial Antigen Presenting Cells to Genetically Modify T Cells from Peripheral and Umbilical Cord Blood
09:29

Clinical Application of Sleeping Beauty and Artificial Antigen Presenting Cells to Genetically Modify T Cells from Peripheral and Umbilical Cord Blood

Published on: February 1, 2013

19.1K

Area of Science:

  • Biotechnology
  • Cellular Therapy
  • Regulatory Science

Background:

  • Initiating early phase clinical trials for novel cellular therapies faces regulatory hurdles.
  • Understanding and implementing current Good Manufacturing Practices (cGMP) is a significant challenge for researchers and clinicians.
  • Lack of familiarity with cGMP requirements impedes the progression of cellular therapy development.

Purpose of the Study:

  • To review the essential aspects of manufacturing genetically modified T cells for therapeutic applications.
  • To provide guidance for investigators navigating the complexities of cGMP for cellular product development.
  • To demystify cGMP requirements for early-phase clinical trial initiation.

Main Methods:

  • Review of Food and Drug Administration (FDA) regulations pertaining to cellular therapy manufacturing.
  • Analysis of key components and principles of current Good Manufacturing Practices (cGMP).
  • Identification of critical manufacturing considerations for genetically modified T cells.

Main Results:

  • Key manufacturing points for genetically modified T cells are identified.
  • Common obstacles in cGMP compliance for cellular therapies are highlighted.
  • A framework for understanding cGMP for early-phase trials is presented.

Conclusions:

  • Successful initiation of early phase clinical trials for cellular therapies depends on robust manufacturing processes.
  • Clear understanding and application of cGMP are crucial for regulatory compliance.
  • This review aims to facilitate the manufacturing of cellular therapies by clarifying cGMP requirements.