Biological activity is a critical quality attribute for biopharmaceuticals, which is accurately
measured using an appropriate relative potency bioassay. Developing a bioassay is a …

The accuracy of reported sample results is contingent upon the quality of the assay
calibration curve, and as such, calibration curves are critical components of ligand binding …

In the era of liquid biopsies, the reliable and cost-effective detection and screening of cancer
biomarkers has become of fundamental importance, thus paving the way for the …

The premise of Quality by Design (QbD) is that the quality of the pharmaceutical product
should be based upon a thorough understanding of both the product and the manufacturing …

Potency is a critical quality attribute to support development and release of
biopharmaceutical products. Researchers assess most protein-drug potencies using …

This review describes why potency is important and how potency can be measured to
release stem cell cellular therapeutic products for transplantation into patients. Particular …

Potency bioassays are used to measure biological activity. Consequently, potency is
considered a critical quality attribute in manufacturing. Relative potency is measured by …

The USP< 1032> guidelines recommend the screening of bioassay data for outliers prior to
performing a relative potency (RP) analysis. The guidelines, however, do not offer advice on …

Parallelism in bioassay is a synonym of similarity between two concentration–response
curves. Before the determination of relative potency in bioassays, it is necessary to test for …

Potency determination via bioassay is a relative measure that requires an evaluation of
parallelism between the dose–response relationships of a reference standard and a sample …