Ensuring Your Biologics Assays Tell the Whole Story
Date: April 23, 2024 11am EDT
Due to their origin in living systems, biologics are complex and inherently variable, posing unique challenges for characterization, consistency, safety, and efficacy. Assays are critical for assuring the identity, potency, purity, and quality of biologics and ensuring both adequate control of manufacturing processes and stability of the products over time.
For the greatest efficiency, assay development should be choreographed in a phase-appropriate manner such that assays are fully validated using the final to-be-marketed product formulation in phase 3 trials. Understanding the regulatory perspective on potency or biological activity is essential for ensuring that the assays developed provide the information needed to support submission and approval.
This webinar will explore the nuances of analytical testing and assay development for biologics and cover regulatory expectations for potency assays for these complex therapeutics.
Topics will include:
- Stages of assay development
- Principles of phase-appropriate assay development
- The model of analytical testing for biologics products
- Regulatory requirements and strategies for successful regulatory agency interactions
Presenters:
Chris Hendry, Vice President, Pharmaceutical Technology
Olu Aloba, Vice President, CMC Services