2-Day Virtual Seminar Method Development and Validation for Assays Supporting Testing of Biologics

Live Seminar: 2-Day Virtual Seminar Method Development and Validation for Assays Supporting Testing of Biologics When: Wednesday & Thursday Sep 22 - Sep 23 , 2021 DAY 01 & 02 (9:30 AM TO 5:30 PM)

Register Now

Biologics continue to be a steadily growing component of the pharmaceutical industry. The advent of large molecule therapeutics requires a different perspective on the assays needed to support development through preclinical and clinical testing. 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.

Learning Objectives:
Understanding the different requirements for small versus large molecules
Mapping appropriate timelines with decision points
Designing, developing, optimizing, and validating key methods
Potency methods, other release and stability methods
Preclinical and clinical methods

Use of DOE and statistical analysis
Defining the validation protocol with real-time capture of data analysis