The method transfer involves moving a bioanalytical procedure from one laboratory environment, often a development or research lab, to another laboratory, such as a quality control laboratory, contract research organization or back to the innovator’s laboratory. The FDA and EMA emphasize documentation, robust comparability studies, and risk-based approaches to method validation. The goal is to ensure the method performs equivalently across sites to maintain product quality, potency, and comparability throughout the product lifecycle. This puts an emphasis on the development of robust methods 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
This presentation will discuss key objectives and considerations of early-phase, mid-phase, and late-phase assay transfers and will compare FDA and EMA guidances for assays transferred to and from BioAgilytix 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.
Learning Objectives:
Understand phase appropriate method transfer considerations.
Comprehend FDA and EMA expectations for method transfers.
Apply strategies to overcome common bioassay transfer challenges.