Modularized PAT Online Training Platform to Accelerate the Workforce Innovation in Biopharmaceuticals Manufacturing

Performance Period: 9/1/2021 to 2/28/2023

In this project, we will create a modularized extensible online training platform on leading-edge process analytical technologies (PAT). The platform can provide large-scale, low-cost, and high-quality life-long customized training for industry, non-profits, and college students, support workforce innovation and facilitate biomanufacturing 4.0. Integrated with existing professional training certification programs on process control, design of experiments, and data analytics, this PAT training platform includes: (1) end-to-end bioprocess hybrid models, which can leverage the existing mechanistic models from each unit operation, provide risk- and science-based production process understanding, and quantify the spatiotemporal causal interdependencies of critical process parameters (CPPs) and critical quality attributes (CQAs); (2) bioprocess risk and sensitivity analyses, which can guide process specifications and troubleshooting, reduce release times, and support quality-by design (QbD); and (3) risk-based prediction, which can provide a reliable guidance on decision making, accelerate process development, and support manufacturing automation. In addition, the digital twin-based virtual lab (vLab) and realistic case studies will be developed to reinforce the biomanufacturing mechanism learning, support the understanding of bioprocess uncertainties, provide experiential learning, and facilitate real problem-solving skills development.