Course Date:  September 5-7, 2017

Course Registration:

Learn how to apply the fundamental principles of Design of Experiments (DoE) methods to the analysis and optimization of bioprocesses. DoE is critical to defining the design space for a process, which is central to the quality-by-design concepts presented in the ICH Guideline for Development and Manufacture of Drug Substances Q11. This course focuses on the application of DoE methods through the use of JMP statistical software, bioprocess case studies and hands-on laboratory activities. The case studies focus on microbial fermentation, chromatography and pharmaceutical product/process development and provide real data. This course is suitable for bioprocess development scientists and engineers; process validation staff interested in defining operating ranges and attribute specifications; and other professionals with previous hands-on bioprocess experience who want to learn about DoE.