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The Evolving Landscape of Potency Assays
There is a “goldilocks” aspect to potency assays. On the one hand, a comprehensive evaluation of the cell product with detailed quantitative...
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Potency Assays for Advanced Stem Cell Therapy Medicinal Products
This volume of the Springer book series Advances in Experimental Medicine and Biology covers potency assays, one of the most complex yet fundamental...
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Potency Assay Development: A Keystone for Clinical Use
Potency can be described as the quantitative measure of biological activity, that is, the ability of an Advanced Therapy Medicinal Product (ATMP) to...
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Advanced Technologies for Potency Assay Measurement
Crucial for their application, cell products need to be well-characterized in the cell manufacturing facilities and conform to regulatory approval...
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Illustrative Potency Assay Examples from Approved Therapies
Advanced therapy medicinal products (ATMP) encompass a new type of drugs resulting from the manipulation of genes, cells, and tissues to generate...
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Potency Assays: The ‘Bugaboo’ of Stem Cell Therapy
Substantially manipulated cell-based products for human use are considered medicines and therefore regulatory authorities require extensive...
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The potency of mesenchymal stem/stromal cells: does donor sex matter?
Mesenchymal stem/stromal cells (MSCs) are a promising therapeutic tool in cell therapy and tissue engineering because of their multi-lineage...
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Identifying Biomarkers for Osteogenic Potency Assay Development
There has been extensive exploration of how cells may serve as advanced therapy medicinal products to treat skeletal pathologies. Osteoblast...
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Direct enhancement of viral neutralising antibody potency by the complement system: a largely forgotten phenomenon
Neutralisation assays are commonly used to assess vaccine-induced and naturally acquired immune responses; identify correlates of protection; and...
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From the Integrity of Potency Assays to Safe Clinical Intervention: Legal Perspectives
Potency assays associated with the efficacy of investigational pharmaceutical products are one of the critical quality attributes that need to be...
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The effect of long-term spaceflight on drug potency and the risk of medication failure
Pharmaceuticals selected for exploration space missions must remain stable and effective throughout mission timeframes. Although there have been six...
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Synthetic dual co-stimulation increases the potency of HIT and TCR-targeted cell therapies
Chimeric antigen receptor T cells have dramatically improved the treatment of hematologic malignancies. T cell antigen receptor (TCR)-based cell...
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Potency Assay Considerations for Cartilage Repair, Osteoarthritis and Use of Extracellular Vesicles
Articular cartilage covers the ends of bones in synovial joints acting as a shock absorber that helps movement of bones. Damage of the articular...
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Release Assays and Potency Assays for CAR T-Cell Interventions
Chimeric antigen receptor (CAR) T-cells are considered “living drugs” and offer a compelling alternative to conventional anticancer therapies....
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Therapeutic potency of A1 adenosine receptor antagonists in the treatment of cardiovascular diseases, current status and perspectives
BackgroundCardiomyocytes form, transport, and metabolize the omnipresent metabolite adenosine. Depending upon the adenosine concentrations and the...
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Determining Potency of Inhibitors Targeting Histone Deacetylase 6 by Quantification of Acetylated Tubulin in Cells
During the preclinical development of small molecule inhibitors, compounds or compound libraries are typically first screened using purified target...
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Clinical Manufacturing of Human Mesenchymal Stromal Cells using a Potency-Driven Paradigm
Purpose of ReviewIn this review, we discuss the current state of scalable manufacturing of a reproducible and potent allogeneic MSC product.
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Potency assays for human adipose-derived stem cells as a medicinal product toward wound healing
In pre-clinical studies, human adipose-derived stem cells (hASCs) have shown great promise as a treatment modality for healing of cutaneous wounds....
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Cryo-EM structure-based selection of computed ligand poses enables design of MTA-synergic PRMT5 inhibitors of better potency
Projected potential of 2.5–4.0 Å cryo-EM structures for structure-based drug design is not well realized yet. Here we show that a 3.1 Å structure of...
