Level: Intermediate
Tiffany Rau, Bioprocessing Expert, Tiffany D. Rau
Wayne J. Levin, President, Predictum
Philip J. Ramsey, Senior Data Scientist and Statistical Consultant and Professor of Mathematics and Statistics, Predictum and University of New Hampshire
Quality by Design (QbD) initiatives are an important part of CMC (Chemistry, Manufacturing, and Control) and essential to a successful journey to final approval for a biologic; either an originator molecule or a biosimilar. QbD also facilitates the development of next generation processes and the learnings from one initiative can often be leveraged for other bio-molecular process development initiatives. The goal is to deliver on scientific and business requirements while meeting or exceeding regulatory expectations. Since QbD requires designing, characterizing, and optimizing every unit operation of the manufacturing process, it requires a synthesis of engineering, scientific, and statistical tools. Although JMP provides a powerful suite of statistical tools for QbD, additional tools are needed to further empower team members to complete QbD initiatives faster as timelines continue to become shorter and shorter. In this presentation we will introduce a new tool, a bioreactor simulator, built on JSL that supports QbD initiatives. During the presentation a live demonstration of the simulator will be given that will show it interacting with JMP: e.g., input experimental designs, analyze results, assess capability, build predictive models, and simulate numerous manufacturing scenarios to find optimized bioreactor design parameters that insure a high quality drug is manufactured through the product lifecycle.
