Development of a Troubleshooting Guide for Modern Automated Cell-processing Systems

Cell Processing Solutions: Optimizing performance through the development of a troubleshooting guide for modern automated cell-processing systems

In the ever-growing cell and gene therapy field, automated cell-processing systems have played a critical role in the development of multiple treatments for patients in need. Despite their multiple benefits, these systems introduce operational challenges that require in-depth troubleshooting and a strong understanding of their mechanism of action. The goal of this capstone project was to develop an operator-friendly, easy to use troubleshooting guide for the most common automated cell-processing systems utilized in a development laboratory at Bristol Myers Squibb (BMS) that adheres to both current Good Manufacturing Practices (cGMP) and current Good Laboratory Practices (cGLP). The main goal was to streamline workflows and minimize process variability, bridging the gaps between vendor manuals and day-to-day laboratory needs. By tracking metrics such as resolution time, error or failure frequency, and operator confidence, we hoped to effectively reduce down and hold times, increase operator efficiency, and support the development of a centralized repository that will provide troubleshooting strategies for all operators in the laboratory and across different BMS sites.