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

You might also read

Related Articles

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

Sort by
Same author

Corrigendum to "Renal Autologous Cell Therapy to Stabilize Function in Diabetes-Related Chronic Kidney Disease: Corroboration of Mechanistic Action With Cell Marker Analysis" [<i>Kidney International Reports</i> Volume 7, Issue 7, July 2022, Pages 1619-1629].

Kidney international reports·2026
Same author

Modulation of ASC-derived extracellular vesicles containing cargo that specifically enhances wound healing.

Frontiers in pharmacology·2025
Same author

Statistical methods for clinical trials interrupted by the severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) pandemic: A review.

Statistical methods in medical research·2024
Same author

Analyses and Utilization of Selectively Tuned Human Adipose-Derived Stromal/Stem Cell Exosomes.

Methods in molecular biology (Clifton, N.J.)·2024
Same author

Group sequential designs for pragmatic clinical trials with early outcomes: methods and guidance for planning and implementation.

BMC medical research methodology·2024
Same author

Renal Autologous Cell Therapy to Stabilize Function in Diabetes-Related Chronic Kidney Disease: Corroboration of Mechanistic Action With Cell Marker Analysis.

Kidney international reports·2022

Related Experiment Video

Updated: Apr 25, 2026

A Real-time Potency Assay for Chimeric Antigen Receptor T Cells Targeting Solid and Hematological Cancer Cells
08:46

A Real-time Potency Assay for Chimeric Antigen Receptor T Cells Targeting Solid and Hematological Cancer Cells

Published on: November 12, 2019

53.3K

Cell-based therapeutic products: potency assay development and application.

Joydeep Basu1, John W Ludlow

  • 1Process Research & Translation, Tengion, Inc., 3929 Westpoint Blvd, Suite G, Winston-Salem, NC 27103, USA.

Regenerative Medicine
|August 28, 2014
PubMed
Summary

Developing robust potency assays for cell-based therapeutics is challenging due to limited mechanistic data. A systematic approach using parallel functional assays is recommended for preclinical development.

Keywords:
bioassaycritical quality attributepotencyprocess research

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

3.9K
An Organotypic High Throughput System for Characterization of Drug Sensitivity of Primary Multiple Myeloma Cells
09:41

An Organotypic High Throughput System for Characterization of Drug Sensitivity of Primary Multiple Myeloma Cells

Published on: July 15, 2015

8.2K

Related Experiment Videos

Last Updated: Apr 25, 2026

A Real-time Potency Assay for Chimeric Antigen Receptor T Cells Targeting Solid and Hematological Cancer Cells
08:46

A Real-time Potency Assay for Chimeric Antigen Receptor T Cells Targeting Solid and Hematological Cancer Cells

Published on: November 12, 2019

53.3K
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

3.9K
An Organotypic High Throughput System for Characterization of Drug Sensitivity of Primary Multiple Myeloma Cells
09:41

An Organotypic High Throughput System for Characterization of Drug Sensitivity of Primary Multiple Myeloma Cells

Published on: July 15, 2015

8.2K

Area of Science:

  • Biotechnology
  • Cell Therapy
  • Drug Development

Background:

  • Potency is a critical quality attribute for biological products, crucial for efficacy.
  • Current cell-based therapeutics often lack rigorous mechanistic data, hindering potency assay development.
  • The US FDA defines potency based on laboratory tests or clinical data demonstrating the intended effect.

Purpose of the Study:

  • To summarize challenges in developing functionally relevant potency assays for cell-based therapeutics.
  • To present perspectives on potency assay development using process R&D examples.
  • To recommend strategies for robust potency assay design in preclinical stages.

Main Methods:

  • Review of challenges in potency assay development for cell-based products.
  • Case studies from process research and development (R&D) of cryopreserved hepatocytes and renal cells.
  • Proposal of a systematic battery of parallel functional assays.

Main Results:

  • Limited mechanistic understanding is a primary barrier to potency assay validation for cell-based therapeutics.
  • A parallel functional assay approach can address multiple potential mechanisms of action.
  • Experiences with hepatocyte and renal cell process R&D illustrate practical challenges.

Conclusions:

  • Rigorous potency assays are essential for cell-based therapeutics but face unique development hurdles.
  • A comprehensive, multi-assay strategy is recommended, particularly during preclinical development.
  • Addressing mechanistic data gaps is key to advancing cell therapy potency assessment.