Method Development and Validation for Assays Supporting Testing of Biologics

This 2-day seminar is designed to offer a broad overview of developing and validating a range of assay methodologies for biologics with specific key analysis of cell culture, assay variability, and DOE. Specifically, this seminar covers essential concepts related to cell-based potency methods, ELISA, and other methods supporting biologics. In addition to potency methods this seminar addresses immunogenicity methods for preclinical and clinical studies. The format of the seminar offers an examination of current best practices as well as time to dissect examples of documentation with emphasis on beneficial systems to consider. Scientists who attend this 2-day seminar will gain knowledge that will be beneficial in helping to achieve well-controlled validated methods.

Topics: "Attend this biologics seminar to learn essential concepts related to cell-based potency methods, ELISA, immunogenicity methods, analytical CMC methods, cell culture procedures, immunogenicity methods, and biomarker validation."