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Understanding Potency Assays and Their Importance in Biologics

As the field of biologics, vaccines, and advanced therapies expands, ensuring their efficacy and safety plays a pivotal role in regulatory approval. One of the keystones to this assurance is potency assays. These assessments are critical not only in determining the effectiveness of a product but also serve as a regulatory necessity.

The Significance of Potency

Potency refers to the strength or effectiveness of a therapeutic agent, and when applied to biologics, it becomes even more crucial. The regulatory agencies expect a thorough understanding of how well a biologic performs under varied conditions. A robust potency assay offers insights that contribute to both the safety profile and therapeutic effectiveness, helping companies navigate through regulatory expectations.

Webinar Details

On September 29, 2025, Xtalks will host a free webinar titled From Bench to Batch: Potency Assays and the Importance of Antibodies. This session aims to shed light on how potency assays are foundational in creating reliable biologics. Register for the event here.

The featured speakers, David Chimento, PhD, from Rockland Immunochemicals, and Kevin Turner, PhD, from Franklin Biolabs, will delve into various aspects of potency assay development. Attendees will gain insights into critical topics such as:
1. Reagent Variability: One of the most pressing issues in potency assays is the variability that can arise from reagents. This can lead to significant repercussions such as the need to revalidate assays, which delays batch release and ultimately increases regulatory risks.
2. Development Strategies: The speakers will provide real-world examples demonstrating how proper planning and use of stable, qualified reagents can streamline the process and improve the performance of potency assays.
3. Regulatory Compliance: The importance of regulatory readiness in potency assays will be emphasized, addressing how consistent quality in critical reagents supports long-term reliability and compliance.

Why You Should Attend

For professionals in pharmaceutical and biotechnology fields, this webinar presents a unique opportunity to learn about the critical procedures that align with regulatory requirements. Whether you are working towards an Investigational New Drug (IND) application, a Biologics License Application (BLA), or commercial scale production, understanding potency assay strategies can enhance your operations.
Moreover, the insights gained from the takeaways of this webinar can assist in reducing revalidation risks and improving overall product quality. A solid grasp of potency assays will be invaluable in ensuring compliance and therapeutic success.

Join the Conversation

Take a step towards refining your knowledge and practices by participating in this informative session. Registrants will have the chance to engage in discussions and ask questions regarding the complexities of potency assays and the methodologies that can enhance their development.

As the landscape of biologics continues to evolve, staying informed about effective potency assay practices is essential for success. Take this opportunity to learn more—mark your calendars for September 29!

For more details or to register, visit Xtalks.

Conclusion

The importance of potency assays is clear—they are not just another regulatory requirement, but a vital element that supports the development of safe and effective biologic therapies. Understanding their impact on product reliability is paramount for industry practitioners. Don't miss out on this opportunity to deepen your understanding and enhance your skills in the field!