Approved biological products are required to be accompanied by analytical tests to demonstrate safety, purity, and potency. Manufacturing and testing processes for approved products are validated and ...

In this free webinar, understand the role of potency assays across biologics and advanced therapies. Attendees will learn how critical reagent variability can compromise assay reliability and lot ...

HOUSTON, Dec. 3, 2025 /PRNewswire/ -- Avance Biosciences today announced the opening of its new Potency and Cell-Based Assay Center of Excellence, a purpose-built facility designed to expand and ...

As gene therapies continue to advance, the demand for scalable, reproducible, and efficient potency assays is rapidly increasing—especially for adeno-associated virus (AAV) vectors. Accurate ...

Iovance Biotherapeutics has made progress in developing potency assays for lifileucel, a tumor-infiltrating lymphocyte therapy for advanced melanoma patients. Developing potency assays for lifileucel ...

There are unique challenges when it comes to cell therapy products, including ensuring the reproducibility and consistency of product lots. These specific concerns arise from the inherent variability ...

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Joshua Hare, MD, FACC, FAHA, Co-Founder, Chief Science Officer and Executive Chairman, Longeveron Thepatent relates to potency assay methods for assessing human mesenchymal stem cells (MSCs) derived ...

Potency is a critical quality attribute of biological products, defined by the US FDA as the specific ability of the product to cause the required therapeutically clinical benefit. Potency assay will ...

GMP-compliant potency assay sample testing for clinical and commercial programs "Our clients have consistently valued the scientific depth and customer-centric approach our teams bring to their ...

The patent relates to potency assay methods for assessing human mesenchymal stem cells (MSCs) derived from bone marrow, adipose tissue, peripheral blood, a lung, a heart, amniotic fluid, inner organs, ...