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 ...
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 ...
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 ...
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 ...
Advances in genetic engineering have improved specificity, safety and potency of T-cell receptor (TCR) and Chimeric Antigen Receptor (CAR-T) based therapies for solid and non-solid tumours. These ...
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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 ...
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 ...
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 ...
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