Accelerated Method Transfer of PK, ADA and Nab Assays

This document is a technical report detailing the accelerated method transfer of pharmacokinetic (PK), anti-drug antibody (ADA), and neutralizing antibody (Nab) assays from the PPD Richmond Lab to the PPD Suzhou Lab in China. The report outlines the growing need for globalization in clinical trials, emphasizing the establishment of the PPD Suzhou Laboratory to facilitate efficient laboratory testing services. The document describes the objectives of assisting sponsors with importing critical reagents, optimizing methods to comply with Chinese regulatory requirements, and completing cross-validation to ensure consistency across laboratories. It also discusses challenges faced during the transfer, including variations in reagents and the need for coordination among different departments. Solutions implemented include assigning project managers, organizing kick-off meetings, and ensuring effective communication between teams. Results indicate successful method transfers and validations, demonstrating consistency in results across labs, with the entire process completed within four months.