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Related Concept Videos

Potentiometry: Overview01:06

Potentiometry: Overview

2.3K
Potentiometry is an analytical technique that measures the potential difference between two electrodes in an electrochemical cell without drawing any significant current that could alter the solution's composition. This method employs an indicator electrode, which exchanges electrons with the analyte solution, and a reference electrode with a constant potential. Each electrode is immersed in a solution comprised of two half-cells. In a conventional setup, the reference electrode serves as...
2.3K
Potentiometric Titration: Overview01:31

Potentiometric Titration: Overview

1.6K
Potentiometric titration is a quantitative analytical technique that determines the concentration of an analyte by measuring the potential difference between the two electrodes in the solution. The endpoint of a potentiometric titration is the point at which there is a significant change in the potential difference. It occurs when the stoichiometric reaction between the analyte and the titrant is complete. The endpoint is usually determined graphically by plotting the measured potential...
1.6K

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Updated: Jul 28, 2025

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The Evolving Landscape of Potency Assays.

Jorge S Burns1

  • 1Department of Environmental and Prevention Sciences, University of Ferrara, Ferrara, Italy. js.burns@unife.it.

Advances in Experimental Medicine and Biology
|May 31, 2023
PubMed
Summary

Developing robust potency assays for advanced therapeutic medicinal products (ATMPs) requires balancing comprehensive evaluation with simplified, scalable methods. Future advancements will aid in creating reliable and cost-effective cell-based therapies.

Keywords:
Acellular productsCAR T-cell researchContract research organizationsCostsCryopreservationInduced MSCInstitutional rolesPotency assay developmentQuality by designScale-up

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Area of Science:

  • Biotechnology and Regenerative Medicine
  • Cellular Therapy Development
  • Assay Development and Validation

Background:

  • Potency assays are critical for evaluating the biological activity of cell products.
  • Current challenges include balancing assay comprehensiveness with simplicity and robustness.
  • Advanced Therapeutic Medicinal Products (ATMPs) require reliable and cost-effective manufacturing and administration.

Purpose of the Study:

  • To explore the "goldilocks" aspect of potency assays, balancing detailed evaluation with simplified approaches.
  • To provide a forward-looking perspective on facilitating potency assay development for ATMPs.
  • To address the need for trustworthy and cost-effective cell-based therapies.

Main Methods:

  • Review of recent advances in potency assay development for acellular products.
  • Exploration of techniques such as cryopreservation, induced mesenchymal stem cells (MSCs), and cell priming.
  • Consideration of nanotechnology, 3D culture, regulatory guidelines, and evolving institutional roles.

Main Results:

  • Identification of key quality attributes for biological activity measurement.
  • Emphasis on lean approaches for assay robustness, reproducibility, and scalability.
  • Discussion of how emerging technologies and regulatory frameworks can overcome current challenges.

Conclusions:

  • A balanced approach is essential for effective potency assay development.
  • Recent scientific and regulatory advances are poised to facilitate future potency assay development.
  • The integration of new technologies and strategies will enable more reliable and cost-effective ATMPs.