For biotherapeutics and vaccines, potency is measured in a bioassay that compares the
concentration-response curves of a new batch to that of a reference standard. Acceptable …

Purpose. To determine the statistical variability expected for a well designed HPLC assay of
a bulk drug substance (BDS). The results are used to develop appropriate acceptance …

Bioassay or biological assay is a type of in vitro experiment that is typically conducted to
measure the effect or activity of a substance or stimulus in a biological system, for estimating …

A validated bioassay is used to measure the potency of commercial lots, and as such, must
be accurate, precise, and fit for its intended purpose. Regulatory expectations for a bioassay …

Recently, the lifecycle management concept for analytical procedures was introduced. It is
strongly related to the Quality by Design concept given in the ICH-Q8 guidance. This …

Bioassay data analysis is used to determine the potency of protein therapeutics. To properly
determine potency, the experimental data need to be fitted to a model that adequately …

Statistical parameters estimated in validation studies to establish the reliability of single‐
concentration assays, such as the Signal Window and Z'‐Factor, are well established. These …

Drug discovery scientists routinely develop and use in-vitro assays; for example, to identify
“hits,” or to quantify the efficacious concentrations of compounds in a lead series. New and …

Compared with biologics, vaccine potency assays represent a special challenge due to their
unique compositions, multivalency, long life cycles and global distribution. Historically …

Vaccine potency assays pose a unique challenge due to the inherent structural complexity,
multivalent composition, long shelf-life and global distribution of vaccines [1]. Potency …