Site Director Smithers - Pharmaceutical Development Services Ewing, New Jersey
Description: As demand for highly sensitive molecular bioanalytical assays grow, optimizing each step in the sample analysis workflow is crucial to developing a robust assay. This presentation addresses practical factors governing assay performance, including nucleic acid extraction efficiency, matrix-related challenges, and platform selection (qPCR vs ddPCR). Validation strategies and fit-for-purpose approaches will also be examined to support reliable, reproducible, and decision-enabling data generation for low-abundance targets and/or high sensitivity assay demands in molecular bioanalysis.
Learning Objectives:
Identify key factors influencing functional sensitivity in molecular bioanalysis, including nucleic acid extraction efficiency, matrix effects, and amplification platform selection.
Compare practical performance considerations of qPCR and ddPCR for low-abundance target detection within fit-for-purpose molecular bioanalytical workflows.
Apply critical validation principles for highly sensitive molecular bioanalytical assays, including fit-for-purpose performance criteria and strategies for robust, decision-enabling data generation.
