BEC 591 606 cGMP Biomanufacturing Operations

3 Credit Hours

This online lecture-based course introduces students to upstream and downstream biomanufacturing for the production of biopharmaceuticals. The course will provide students with key upstream fermentation and cell culture concepts used by biomanufacturing industries including microbial growth, bioreactors, process controls, etc. Downstream concepts include separations, homogenization, chromatography, and ultrafiltration. There will be a specific focus on scale-up and cGMP operations for both upstream and downstream unit areas.

Prerequisite

P: BIO 183 and CH 221 or 225.

Course Objectives

Introduce students to a variety of biopharmaceutical product types

Present concepts related to design and execution of processes for biopharmaceutical manufacturing, starting with aerobic fermentation processes, the use of bioreactors for mass cultivation of microbes for biomanufacturing, and key fermentation process indicators including growth kinetics and yield coefficients through basic analytical assays

Present typical downstream unit operations for recovery and purification of biopharmaceutical products, including their purpose and parameters likely to impact their performance and cover basic concepts involved in developing and scaling up downstream processing steps

Describe current Good Manufacturing Practice (cGMP), including why and how it is implemented in biopharmaceutical manufacturing.

Course Outline

Week 1: Introduction to biomanufacturing products and process; Overview of biomolecule structure and properties (focus on proteins); Introduction to current Good Manufacturing Practices
Week 2: Introduction to Microbial Growth
Week 3: Expression Systems
Week 4: Introduction to Bioreactors
Week 5: Oxygen Transfer
Week 6: Sterilization Methods
Week 7: Probes and Biosensors
Week 8: Process Controls
Week 9: Introduction to Downstream Processing; Introduction to Harvest Stage; Cell Lysis
Week 10: Solid-Liquid Separations; Disc Stack Centrifugation
Week 11: Depth Filtration; calculation workshop; Exam 1
Week 12: Downstream Measurements; Introduction to Chromatography
Week 13: Chromatography Procedures and Equipment; Chromatography Scale-up and Design
Week 14; Chromatography Design workshop; Introduction to Ultrafiltration, equipment, and procedures
Week 15: Ultrafiltration Design; Filling and Final Finish
Week 16: Final Exam

Textbooks

None.

Software Requirements

Reliable Internet access.

Updated: 6/23/2023