Potency Assays for Modern Biologics:
Expert Insights and Future Trends
About this webinar
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
- 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
- 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
Featured Speakers
Silvia Mattick
As a Biochemical Engineer, Silvia brings a comprehensive background in biotherapeutic potency assays, spanning early research to commercial quality control. Her career’s 14 years trajectory, from bench scientist to People Lead at Roche Mannheim and subsequently to People and Science Lead at Roche’s Large Molecular Research in Penzberg in 2020, highlights her dual expertise in scientific strategy and team leadership. Shaped by her extensive commercial experience, Silvia champions the integration of an end-to-end development strategy at the very beginning of the assay lifecycle. Furthermore, she is actively driving the transition to serum-free cultures and assays, demonstrating her continuous drive to advance the frontiers of bioassay development and scientific excellence.
Paulo Roky Bamert
Paulo “Roky” Bamert is an Associate Director in Analytical Development Bioanalytics at Novartis Pharma AG. He studied Cell and Molecular Biology at the University of Basel, Switzerland. Following graduation, he joined Roche, where he worked on bioassays in a GMP-regulated quality control laboratory. In 2009, he joined Novartis and has since worked in a variety of scientific and leadership roles within Bioanalytics. Over the years, he has supported the development of numerous biologics and biosimilars from early research through late-stage clinical development. In his current role, Roky supports bioanalytical strategies and the development of innovative analytical approaches for biologics and emerging therapeutic modalities.
Agnieszka Lewandowska
Agnieszka Lewandowska is an analytical CMC leader with over 20 years of experience developing bioassays for biologics and advanced therapeutic modalities. At Immunocore, she leads CMC bioassay development and testing, overseeing cell-based and cell-free potency methods, qualification, technical transfer to external GMP manufacturers, validation and regulatory submissions. Prior to Immunocore, she drove analytical programmes across cell and gene therapies and complex engineered proteins at Oxford Biomedica and Ipsen Bioinnovation. Agnieszka specialises in translating intricate mechanisms of action into robust, function-reflective potency strategies that perform reliably across the product lifecycle. A strong proponent of modernising analytical workflows, she actively champions Analytical Quality by Design (AQbD), semi-automated execution on liquid-handling platforms and AI-assisted statistical modeling to predict assay robustness and stability.
Partner for this event
Svar Life Science
Svar Life Science is a life science company with proud Scandinavian roots and values, and a global perspective. We offer a unique combination of scientific expertise, high-quality assay products, contract research services, and proprietary technology platforms that together provide a flexible, effective, and seamless experience for customers through different development needs in a way that no other single business can.
Our Potency capabilities help biopharma companies design, develop, validate, and optimize function-reflective, biologically relevant assays that generate robust, reliable data to support critical development and regulatory decisions. Backed by strong expertise in immunology, immunogenicity, complement biology, and cell-based assay custom development, we help customers navigate evolving expectations for potency testing as therapies become increasingly sophisticated.
At Svar, we help you tackle your development problems, so that you can safely and efficiently progress your candidates through the drug development phases and to the patient.