BIOT 5640: Drug Product Processes for Biopharmaceuticals
Lecture - 3 credits
- Covers the development and implementation of the drug product manufacturing process for biopharmaceuticals.
- Focuses on biologic products, specifically proteins.
- Covers the workflow required for the development and implementation of the production process with the scientific and engineering principles highlighted.
- Topics include the preformulation process for early stage product development, the selection of formulation compatible with the targeted product presentation, optimization of formulations to meet stability and usage objectives, the design of a scalable process for production, large-scale process equipment and operations, process scale-up considerations, and regulatory compliance issues for drug product manufacturing facilities and operations.
- Students who do not meet course prerequisites may seek permission of instructor.
Covers the development and implementation of the drug product manufacturing process for biopharmaceuticals. Show more.