cGMP Fermentation Operations
This laboratory-based course focuses on the application of microbial fermentation techniques at production scale and evaluation of the issues inherent in the integration of microbial fermentation unit operations, scale-up/production, and current Good Manufacturing Practice (cGMP) compliance. This course is organized around six laboratory sessions that follow the process of making a protein at commercial scale. Lectures associated with lab sessions prepare students for pilot-scale laboratory experiences in media preparation, bioreactor operation, process utilities, and manufacturing quality systems that relate to microbial fermentation in a commercial cGMP facility.
This course is delivered in a hyflex format, which means students may choose to attend any lecture and/or any laboratory session either in person or online. (Note that in-person attendance is required for one course activity.) Students choosing to attend any lecture or laboratory online have the option of joining that session virtually in real time or viewing a recording made previously.
- Large-scale biosafety and cGMP operations
- Facilities and utilities
- Equipment qualification
- Cleaning in place: design and validation
- Automation and process control
- Deviations and failure investigations
- Large-scale safety, cleanroom operations, cGMP documentation
- Warehouse, weigh-outs, utilities
- Equipment and process qualification
- Clean-in-place operations
- Automation and data analysis
- Failure investigations
At the end of this course, students should be able to:
- Prepare cGMP-compliant documentation and follow Standard Operating Procedures (SOPs) as they pertain to upstream manufacturing operations.
- Apply the concepts of equipment qualification and cleaning validation in the context of upstream biomanufacturing operations.
- Describe facilities and services in support of upstream biomanufacting operations.
- Analyze common process failures to determine root cause and develop CAPAs.
Prerequisites & Requirements
BBS 426 is a co-requisite.
All reading assignments will be available on the course website, other internet websites (especially the U.S. FDA web site), BTEC cGMP-simulated documentation, and laboratory manuals (all provided by BTEC). All laboratory attire and safety equipment will be provided.