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Sílvia Torrents^1,2, Marta Grau-Vorster^1,2, Joaquim Vives^3,4,5

¹Banc de Sang i Teixits, Edifici Dr. Frederic Duran i Jordà, Barcelona, Spain.

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Summary

Defining potency tests for advanced therapy medicinal products (ATMPs) is challenging due to living cells and unclear mechanisms. This chapter reviews current ATMP potency assays and discusses future harmonization needs.

Keywords:

Approved ATMP CAR T-cell potency CAR T-cell therapy Cell therapies Compliance Epithelial stem cells Gene therapies Hematopoietic stem cells Immunotherapy Tissue engineering

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Area of Science:

Biotechnology
Pharmacology
Regenerative Medicine

Background:

Advanced therapy medicinal products (ATMPs) are innovative drugs derived from manipulating genes, cells, and tissues.
Developing suitable potency tests for ATMPs is complex because their active ingredients are living cells with often poorly understood mechanisms of action.

Purpose of the Study:

To present and discuss current potency assays for commercial ATMPs.
To examine the biological relevance of these assays and identify challenges for harmonization and regulatory compliance.

Main Methods:

Review of existing potency assays for representative commercial ATMPs.
Analysis of specific product categories: gene therapy (KYMRIAH®), cell therapy (Holoclar®), and tissue-engineered therapy (PROCHYMAL®/RYONCIL™).

Main Results:

Potency assays vary significantly across different ATMP categories.
Selected assays may not fully capture the biological relevance of the therapeutic effect.

Conclusions:

Standardization and harmonization of potency assays are crucial for ATMP quality and regulatory approval.
Further research is needed to ensure biological relevance and broader implementation of ATMP potency testing.