#None #Xtalks #Biologics Development #Potency Assays

Understanding Potency Assays in Biologics Development

The landscape of biologics development is evolving rapidly, with potency assays playing an increasingly pivotal role in ensuring the efficacy and safety of therapeutic products. Aiming to shed light on this essential component, an upcoming free webinar hosted by Xtalks delves into the strategies surrounding potency assays, helping developers navigate through the complexities of biologics.

What are Potency Assays?

Potency assays are critical quality tests that assess a therapeutic product's biological activity and its ability to produce the desired effect in a patient. As enthusiasts and professionals in the biopharma sector prepare to engage with this topic, it’s vital to understand that potency is considered one of the critical quality attributes (CQA) in the development of biologics. It links the therapeutic product's mechanism of action (MoA) to its clinical effectiveness, thus influencing regulatory decisions throughout the development process.

Webinar Insights

Participants will hear from industry experts who will cover several key areas related to potency assay strategies:

• - Phase-Appropriate Assay Design: Understanding the significance of designing assays that are tailored to specific phases of drug development is vital for meeting regulatory expectations.
• - Regulatory Challenges: Experts will share insights into the evolving regulatory landscape and how companies can navigate these challenges while ensuring their assays remain compliant.
• - Complex Therapeutic Modalities: With the emergence of novel therapeutic modalities, the need for robust and relevant potency assays is greater than ever. The panelists will discuss innovative platforms and technologies that address these needs.

Featured Speakers

The webinar will feature prominent industry professionals:

• - Silvia Mattick, People Science Lead at Roche, brings her extensive expertise in immunology.
• - Paulo Roky Bamert, Associate Director at Novartis Pharma AG, will discuss analytical development bioanalytics.
• - Agnieszka Lewandowska, Associate Director at Immunocore, lends her insights into analytics and quality control.
• - Therese Segerstein, Portfolio Director at Svar Life Science, will moderate the discussion, ensuring a comprehensive exploration of the topic.

Innovations in Potency Testing

The future of potency testing lies in the integration of cutting-edge technologies. The experts will explore:

• - Platform Technologies: How these tools can streamline the assay process and enhance reliability.
• - Automated Systems: The role of automation in improving accuracy and efficiency in testing.
• - Improved Characterization Techniques: New methods that allow for better characterization of products, heightening the relevance of assay outcomes.

By attending this webinar on November 11, 2026, at 9:30 AM EST, participants will gain valuable insights that can improve their potency testing strategies, ensuring that they remain aligned with both scientific and regulatory demands.

Conclusion

As the biopharmaceutical landscape becomes ever more complex, the relevance of effective potency assays cannot be overstated. This Xtalks-hosted webinar aims to arm professionals with the knowledge and strategies they need to thrive in an evolving field, making it a must-attend for those involved in the development of biologics. Participants will walk away with actionable insights and best practices that will guide them in creating scientifically relevant, robust, and compliant potency assays.

To register for the webinar, visit Xtalks.

About the Host: Svar Life Science

Svar Life Science stands at the forefront of life sciences, offering a unique combination of scientific expertise and high-quality assay products tailored for the biopharma industry. The company’s capabilities assist clients like Roche and Novartis in navigating the rigorous expectations tied to potency testing, ultimately ensuring that therapies are safe and effective.

For more information on upcoming events and innovative solutions in potency testing, check out Svar Life Science’s offerings.