2024 - Ensuring Your Biologics Assays Tell the Whole Story

Due to their origin in living systems, biologics are complex and inherently variable, posing unique challenges for characterization, consistency, safety and efficacy. Biologics 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 III 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.
Register for this webinar today to gain insights into the development stages for biologics assays, the analytical testing model for biologics and more.
Keywords: Formulation, Drug Development, Biologics, Biosimilars, Regulatory, Assay Development, Analytical Testing, Commercial Manufacturing, Bioanalytical Testing, Biologics Manufacturing, Pre-Clinical