Scientific Poster: Outlier Analysis for Relative Potency Assays

Published on March 22, 2024

At the recent 2024 US Bioassay Conference, which took place in Long Beach, CA on March 11-13, our Associate Director of Analytical Methods Development, Alena Nikolskaya, gave a poster presentation entitled: “Outlier Analysis for Relative Potency Assays Using SoftMax Pro Function for Rosner Extreme Studentized Deviate Test.”

Overview:

Our outlier analysis approach for dose-response curves in relative potency assays utilizes customized SoftMax Pro1 data acquisition and analysis software templates to perform all calculations, processing and reporting without any data transfer to another statistical program.

Outliers are determined based on the residuals from independent curve fit using SoftMax Pro function for Rosner extreme studentized deviate test: “ESD Mark Outliers (data, outliers, significance)”.

Distributions of the residuals are tested for normality with and without identified outliers using SoftMax Pro function for Shapiro-Wilk Royston probability test: “ShapiroWilkRoystonProbability(data)”. The rationality of outlier exclusion is based on the comparisons of the results of normality tests using distribution of the residuals of the standard curve without outliers typical for relative potency assay.

Click Here to Access the Poster

Abzena’s Bioassay Expertise

Abzena has decades of experience in developing bioassays for biologic and bioconjugate programs.  Our unique approach focuses on developing phase-appropriate assays for the assessment of potency, efficacy, and safety, providing our customers with the tools to make effective decisions to ensure downstream clinical and commercial success.  We offer comprehensive bioassay solutions, which include both established assays and custom assay development matched to your individual program needs. In discovery, we support our customers with target validation and hit-to-lead screening.  As we transition programs onwards toward design and developability, we can support our customers with specificity and tissue profiling, mode of action (MOAs) and immunogenicity assessments.  When it’s time to start manufacturing, we offer potency and batch-release support.

Find out more about our bioassay capabilities by clicking here.

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