Japanese–English glossary
Bioassay
Also called potency assay
バイオアッセイ（力価試験）baioassei (rikka shiken)
Also written 力価試験、バイオアッセイ、細胞ベース法
A test that measures a product's biological activity through its effect on living cells, tissues, animals or a biochemical system, used as the potency assay for biologics, vaccines and cell and gene therapies. It reflects the mechanism of action in a way a content assay cannot. The Japanese word used for potency here (力価) also means titer, so read the context: a viral vector titer and a potency assay are different specifications. Bioassays vary more than physicochemical tests, so assay design, the reference standard and system suitability rules matter as much as the readout.