The demand for robust and scalable lentiviral vector manufacturing processes for cell and gene therapy has driven the adoption of advanced methodologies. This presentation delves into an innovative approach to process development, focusing on a Quality by Design (QbD) strategy, with a particular emphasis on the powerful capabilities of JMP software.

In adherence to stringent regulatory requirements for Process Performance Qualification, our methodology seamlessly integrates traditional and modern principles while leveraging JMP as a critical tool during the Stage 1 Process Design phase of the Process Validation life cycle. Utilizing JMP for design of experiments (DOE) facilitates comprehensive characterization of the lentiviral vector manufacturing process, enabling precise identification of Critical Process Parameters (CPPs) and the establishment of Proven Acceptable Ranges (PARs).

By harnessing the statistical analysis and visualization features of the software, we ensure a data-driven approach to decision making, enhancing process understanding and control. This talk emphasizes the key role JMP plays in advancing the application of QbD principles to meet the evolving demands of bioprocessing.