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 ...

Microbial assays are a technique to assess a compound’s potency or concentration. This is carried out by exposing microorganisms to the compound and determining its effect on them. Microbial assays ...

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 ...

Mesoblast has taken another step on the path toward its third attempt to win approval of its off-the-shelf therapy, exiting a meeting with the FDA convinced that new potency assay data and a ...

Since biological therapeutics are derived from living organisms, their manufacture and validation presents difficulties not encountered during traditional small molecule drug development. Despite the ...

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 ...

BIOLOGICAL assays may be divided into two main classes. In the first, which we may call Type I, the 'potency' of the test material, as compared with that of a standard preparation, refers only to its ...