- TypeSeminar
- Location New York, United States
- Date 24-06-2021 - 25-06-2021
Education/Teaching/Training/Development
Medical/Healthcare/Hospital
OTHERS
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)
Click here to Register Seminar
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