Bioprocess Unit Operations and GMP Exercises

• Explain principles and main components of relevant unit operations for biomanufacturing
• Recognize technical components on real life plants.
• Evaluate cleanability and hygienic design of these components
• Operate a pilot scale experimental setup, incl. data acquisition, control manipulation, and sampling.
• Maintain good operating condition by monitoring critical process parameters
• Analyze results and apply theory on practical experimental problems.
• Formulate conclusions concerning the quality of the experimental data and applicability of the theory
• Analyze a process operation’s conformity to GMP standards.

This practical course includes 4 unit operation exercises and 3 Good Manufacturing Practice (GMP) exercises which are performed in groups of 3 students.
The unit operation exercises cover a full biomanufacturing process: Upstream fermentation exercise for all groups (2 full days) as well as 3 selected unit operations (1 day each) from the following downstream unit operations: Centrifugation, Homogenization, Rotary Drum Vacuum filtration, Ultrafiltration, Ultrafiltration with vibrating membrane, Protein purification with Ion Exchange Chromatography.
The three GMP exercises include: I) a hygienic evaluation of one of the above used units. II) a cleaning in place (CIP) and sterilization in place (SIP) exercise, and III) an audit exercise with the aim of auditing a fictional biomanufacturing company using the previously used processing equipment according to EudraLex Vol 4
6 reports have to be handed in, which includes 4 reports from the unit operation exercises, were one includes the executed hygienic evaluation. The CIP/ SIP report contains results from the CIP exercise as well as the Sterilization in place (SIP) from the fermentation exercise. Finally, an audit report based on the audit roleplay with the fictional pharma producer has to be made. Overall, the course contains 6 mandatory physical exercise days, 4 days with classroom activities (e.g. introduction to exercises, audit roleplay). The rest of the time is reserved for exercise preparation and report writing.

• 36 – 49

Theoretical course in chemical unit operation/process technology is necessary. Basic knowledge in inorganic, organic, analytical chemistry, physics, thermodynamics and mathematics is required to solve the report questions. It is expected that missing theory will be revised on a self-study basis.

Exercises in pilot scale

Maximum: 30.

Please be aware that this course has a limited number of seats available. If there are too many applicants, a pool will be created for the remainder of the qualified applicants, and they will be selected at random. You will be informed 8 days before the start of the course, whether you have been allocated a spot.