Bioassay Method Transfer Strategies to Reduce Variability

Bioassay variability can pose significant challenges due to laboratory conditions, instrumentation, analytical software, cell culture performance and reagent sourcing. These inconsistencies can impact assay reproducibility, data integrity and regulatory compliance, ultimately affecting product quality and potency assessments. This webinar will highlight phase-appropriate strategies that balance flexibility in early development with the rigour required for late-phase validation, ensuring method consistency.

Recent guidance from regulators emphasizes bioassays and potency assurance strategies, underscoring the robustness of these assays and their ability to be moved across multiple locations throughout product development.

The method transfer involves relocating a bioanalytical procedure from one laboratory environment, often a development or research lab, to another, such as a quality control lab, a contract research organization or back to the innovator’s lab. The FDA and EMA emphasize documentation, robust comparability studies and risk-based approaches to method validation. The aim is to ensure the method performs consistently across sites to maintain product quality, potency and comparability throughout the product lifecycle. This emphasizes the development of robust processes and a strong understanding of their critical attributes.

Key strategies for mitigating variability include:

• Reproducibility and Robustness: Demonstrate the assay yields compatible results across laboratories
• Documentation: Thorough records of the method, the assay performance and modifications
• Risk Assessment: Identifying critical assay parameters and implementing controls and procedures to mitigate risk
• Critical Attributes: Often identified through acceptance criteria but may include technique, reagents and details
• Phase Appropriate Considerations: The rigor of assay transfer and validation typically escalates as a product moves from early-phase clinical development toward commercialization

The featured speakers will discuss key objectives and considerations of early-, mid- and late-phase assay transfers and will compare FDA and EMA guidance for assays transferred to and from CMC testing laboratories (ICH Q2(R2), USP <1224> and EU GMP Chapter 6). Case studies will highlight the challenges and present solutions to illustrate how proactive planning, detailed transfer plans and adherence to regulatory guidelines can ensure assay performance remains consistent across laboratories.

Register for this webinar to learn how bioassay method transfer strategies support reliable assay performance and minimize variability.

Speakers

(Moderator) Jessica Weaver, MRes, Scientific Officer, CMC, BioAgilytix

Jessica Bridges Weaver brings over 18 years of expertise in pharmaceutical development of upstream and downstream processes and bioanalytical testing in support of Chemistry, Manufacturing and Controls (CMC). Before joining the Scientific Office, she led a team of CMC scientists as an Associate Director at BioAgilytix. Prior to that, she worked as a Scientific Project Manager for Manufacturing Research and Development for academic and contract organizations. Mrs. Weaver completed her BS in Biological Engineering and a Master’s in Fermentation, both at North Carolina State University.

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Katie Harcher, MS, Bioanalytical Project Manager, BioAgilytix

Katie Harcher, MS, is a Bioanalytical Project Manager at BioAgilytix Labs, a contract research organization based in Durham, NC. In this role, she leads a team in the CMC department through all aspects of bioassay lifecycles, including development, validation and regulated sample testing. Previously, she was a Principal Scientist and Team Leader of Analytical Development at Athersys, Inc., where she designed, validated and managed novel characterization assays for cell therapy products in the Regenerative Medicine field. With a focus on cell-based potency assays, she has widespread experience in techniques such as ELISA, MSD, Flow Cytometry, cytotoxicity assays, proliferation assays and ddPCR. Katie received her BS in Biology from John Carroll University and her MS in Microbiology and Immunology from the University of Virginia.

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Julia Hecker, PhD, Principal Investigator, BioAgilytix

Bio Coming soon.

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Leigh Laundon, PhD, Manager I, BioAgilytix

Leigh Laundon, PhD, Manager I, earned a BS degree in Biomedical Engineering at North Carolina State University and a PhD in Biomedical Engineering from Duke University. Dr. Laundon has seven years of industry experience in the CRO/CDMO landscape with a background in a variety of CMC assays. She also has extensive research experience with a range of cell lines for drug development. She currently manages teams in the development and validation of cell-based potency assays with an emphasis on ELISA and PCR platforms.

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