As the biologics landscape becomes increasingly complex and therapeutic modalities grow more sophisticated, potency assay strategies are evolving from regulatory requirements into powerful tools that provide biologically meaningful measures of product function, quality and mechanism of action.
Join this expert-led webinar exploring how developers can design potency testing strategies that generate biologically relevant insights into therapeutic candidates while meeting regulatory expectations.
Potency testing sits at the intersection of product characterization, quality control and regulatory compliance, making it one of the most critical and challenging aspects of biologics development. Potency is considered a critical quality attribute (CQA) that links a therapeutic product's mechanism of action (MoA) to its clinical effect and supports biological understanding throughout the development continuum.
In this webinar, industry experts will explore how to develop successful potency strategies for biologics and increasingly complex therapeutic modalities. The panelists will discuss key decisions and pitfalls, lessons learned, best practices and practical strategies for developing potency assays that are scientifically relevant, fit-for-purpose and phase-appropriate.
As novel therapeutic modalities continue to emerge, developers require function-reflective assays that provide reliable and quantitative measures of biological activity. The speakers will also examine how innovations such as platform technologies, engineered reporter cell systems, assay-ready formats, automation and improved product characterization are shaping the next generation of potency strategies.
Register for this webinar to learn how robust potency testing can support meaningful measures of biological activity, product quality and regulatory readiness across biologics development.
Who Should Attend
This webinar will appeal to:
Analytical Development Scientists
CMC and Product Development teams
Quality and Control Functions professionals
Regulatory Affairs professionals
Biopharmaceutical leaders
Emerging Therapy Developers
Contract Research and Testing Organizations
Academic and Translational Researchers
What You Will Learn
Attendees will:
Understand how potency strategies and technologies are evolving
Gain practical insights on how to measure potency in complex modalities
Learn more on current regulatory thinking and industry best practices
Explore future-ready potency approaches
Register free on Xtalks:
https://xtalks.com/webinars/potency-assays-for-modern-biologics-expert-insights-and-future-trends/
