Abstract:
Our specific outlier identification approach for dose-response curves in relative potency assays utilizes SoftMax Pro data acquisition and analysis software templates to perform all calculations without any data transfer to another statistical program.
Outliers are determined based on the residuals from the 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.
The approach aligns with the best practices recommended in the field of bioassay potency testing, where outlier screening is crucial to avoid biased relative potency estimates and false acceptance/rejection of samples.
The use of software tools for outlier identification and normality testing is in line with the guidance provided by USP<1032> and is essential for ensuring the accuracy and reliability of relative potency analysis.
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.
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