The growing demand for robust, scalable lentiviral vector manufacturing processes in cell and gene therapy has accelerated the adoption of advanced methodologies. This presentation highlights an innovative Quality by Design (QbD) approach to process development, with an emphasis on leveraging the powerful capabilities of JMP software.
To meet stringent regulatory requirements for Process Performance Qualification (PPQ), our methodology integrates traditional and modern principles while leveraging JMP as a critical tool within the Stage 1 Process Design phase of the process validation lifecycle. Using JMP for design of experiments (DOE), we enable comprehensive characterization of the lentiviral vector manufacturing process, precise identification of critical process parameters (CPPs), and the establishment of proven acceptable ranges (PARs).
By harnessing JMP’s statistical analysis and visualization tools, we ensure a data-driven approach to decision making, enhancing process understanding and control. This talk emphasizes JMP’s pivotal role in applying QbD principles to meet the evolving challenges of bioprocessing in a regulated environment. In addition, it includes a live demonstration of how the Design Space Profiler was used to define robust PARs.
Presenters
Skill level
- Beginner
- Intermediate
- Advanced
