A Practical Approach to Teaching DOE for Biomanufacturing Using JMP (2026-EU-PO-2865)

Design of experiments (DOE) is a cornerstone of process development in the biopharmaceutical industry and a key component of Quality by Design (QbD) principles. However, many professionals entering the biomanufacturing field come from diverse academic backgrounds with limited exposure to structured experimental design. To address this gap, a three-day intensive course was developed at  the Biomanufacturing Training and Education Center jin Raleigh, NC, to introduce the concepts and practical applications of DOE within the context of biomanufacturing.

The course integrates three complementary components: (1) theoretical instruction covering the statistical foundations and rationale of DOE, (2) guided hands-on exercises using JMP to design, analyze, and interpret experiments, and (3) case studies derived from real biomanufacturing processes. This combination allows participants to connect abstract statistical principles with practical process challenges, enhancing both conceptual understanding and technical proficiency.

This educational model demonstrates an effective framework for training multidisciplinary professionals in DOE for biopharmaceutical process development. By coupling interactive software-based learning with authentic biomanufacturing examples, the course bridges the gap between statistical theory and industrial practice, supporting the development of a data-driven workforce aligned with QbD objectives.