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: Thursday & Friday Jun 24 - Jun 25 ,2021 DAY 01 & Day 02 (9:00 AM TO 5:00 PM EDT).

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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.

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

Handling of critical materials

Process monitoring concepts

Assessment of orthogonal methods

Assessing readiness for validation

Defining the validation protocol with real-time capture of data analysis

Maintaining quality through documentation