BIOE474
Biopharmaceutical Process Development and Manufacturing
Covers the fundamental steps involved in process development and manufacturing of biopharmaceuticals. An overview of different classes of biopharmaceuticals as well as manufacturing requirements for clinical development and regulatory approval will be provided. In depth coverage of manufacturing steps including cell culture, purification and formulation as well as drug product manufacturing, analysis and stability will be covered. Scientific literature will be used to highlight current challenges and novel solutions in each step of the manufacturing process. Scale up considerations, GMP requirements and process economics will also be introduced.
Spring 2026
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During the Spring 2020 and Spring 2021 semesters, students could choose to take some of their courses pass-fail mid-semester which skews grade data aggregated across multiple semesters.
Average GPA of 3.55 between 34 students*
* "W"s are considered to be 0.0 quality points. "Other" grades are not factored into GPA calculation. Grade data not guaranteed to be correct.