When it comes to biologics, vaccines and advanced therapies, potency is not just a requirement; it’s the backbone of regulatory success and therapeutic efficacy. The development of reliable potency assays relies on more than good design: it depends on the stability, quality and reproducibility of the critical reagents that enable their performance. One of the most common and costly causes of assay failure is reagent variability, which can result in revalidation, delays in batch release and increased regulatory risk.
In this joint webinar, the featured speakers explore the crucial connection between reagent quality and successful potency assay development. They will walk through the planning and development of potency assays and how stable, qualified critical reagents can reduce the need for revalidation, streamline tech transfer and support robust QC performance across therapeutic modalities.
Whether working toward an investigational new drug, a biologics license application or commercial scale, register for this webinar to learn potency assays strategies that improve robustness while reducing revalidation risk.
Speakers
David Chimento, PhD, VP of R&D, Rockland Immunochemicals, Inc.
David Chimento, PhD, is Vice President of Research and Development at Rockland, bringing over 15 years of academic and industry experience in antibody generation, immunoassay development and molecular biology. He leads Rockland’s custom services and contract research programs, collaborating closely with biotech, pharma and academic partners to align reagent development with scientific and regulatory needs. His leadership ensures that Rockland’s reagents meet the highest standards of performance and stability, making him a key voice on how antibody quality supports robust and reliable potency assays.
Kevin Turner, PhD, Executive Director, Analytics, Franklin Biolabs
Kevin Turner, PhD, is a scientific leader with over 15 years of experience in analytical testing and CMC strategy for biologics and gene therapy. He currently serves as Executive Director of Analytics at Franklin Biolabs, where he leads a high-performing team focused on delivering analytical excellence and regulatory support.
Previously, at the University of Pennsylvania’s Gene Therapy Program, Dr. Turner advanced potency assay development and managed stability programs — experiences that shaped his deep understanding of the critical role robust potency assays play in product development.
Who Should Attend?
This webinar will appeal to professionals in the following industries and areas:
- Biologics, cell and gene therapy companies
- Analytical Development Scientists and QC teams (responsible for assay design, validation and implementation)
- Processes Development and CMC teams
What You Will Learn
Attendees will:
- Understand the role of potency assays across biologics and advanced therapies
- Learn how critical reagent variability can compromise assay reliability and lot release
- Hear real-world examples on development strategies and what makes potency assays “regulator-ready”
- Discover how support partners enhance long-term assay reliability through reproducible, high-quality critical reagents
Xtalks Partner
Rockland
Established in 1962, Rockland Immunochemicals, Inc. is a privately held biotechnology company specializing in antibody and protein production near Philadelphia, Pennsylvania. As a trusted partner to the global life science community, Rockland supports academic, diagnostic, and biopharma research with high-quality, validated antibody-based tools. Our products are designed to advance discovery and ensure confidence in complex applications.
You Must Login To Register for this Free Webinar
Already have an account? LOGIN HERE. If you don’t have an account you need to create a free account.
Create Account