LEVEL 5 TRAINING PROGRAMME PART-TIME PROGRAMME TRAINING BASE: CARRIGALINE Block 1: Introduction, Cell Biology, Microbiology, Cell Culture Scale-up, Bioreactor Design Principles, Bioreactor Operations and Control. Bioreactor Disposable Technologies. TOPIC Week 1. Intro to Bioprocessing. Over view of course. Tour of training facility. DURATION DATE LOCATION DELIVERER ½ day theory. Sat. May 28th CARRIGALINE UQ Principles of Cell Biology. Week 2. Principles of Microbiology. Cell Culture Techniques. ½ day theory. 1½ day theory. Friday 3rd June Sat. June 4th CARRIGALINE UQ 1 day theory. Sat. June 11th CARRIGALINE KC Week 3. Bioreactor Operations. PART-TIME PROGRAMME TRAINING BASE: CARRIGALINE 1 LEVEL 5 TRAINING PROGRAMME Block 2: Bioreactor Operations and Controls; NIBRT Cell Culture Lab. in Dublin. Protein Purification Technologies, Downstream Processing. TOPIC Weeks 4. Bioreactor Operations – theory, practicals and assessments. Weeks 5. Bioreactor Operations – theory, practicals and assessments. Week 6. NIBRT Cell Culture Laboratory in Dublin. Cell growth, Cell counting techniques, Aseptic transfer, Bioreactor inoculation, Vicell operation, Bioanalyser operation and analysis. Week 7. Introduction and Downstream Processing Theory. Weigh and dispense / media-buffer preparation / WFI usage. Week 8. Downstream Processing Theory Contd. DURATION DATE LOCATION DELIVERER 1 day – theory practicals and assessments. Sat. June 18th CARRIGALINE KC 1 day – theory practicals and assessments. Sat June 25th CARRIGALINE AF 1 day practical. Sat. July 2nd NIBRT Lab. Dublin. 1 day – theory, practical and assessments. Sat. July 9th CARRIGALINE PALL 1 day - theory and practical and assessments. Sat. July 16th CARRIGALINE PALL Downstream Filtration Practical incl. 2 LEVEL 5 TRAINING PROGRAMME Filter Design and Filter Integrity Testing. Week 9. Purification processes Protein Purification / Separation Techniques / Column Design / Packing / Chromatography Systems. 1 days - theory and practical and assessments. Sat. July 23rd 3 CARRIGALINE PALL LEVEL 5 TRAINING PROGRAMME Block 3: Sterilisation / Sanitisation Techniques, Cleanroom Technologies, Formulation and Fill Finish, Regulatory Affairs / Validation, Revision and Theory Exam. TOPIC Week 10. Sterilisation Techniques / Cleaning and Sanitisation / Autoclaving. Week 11. Clean room Operations / HVAC Systems. Cleanroom Environmental Monitoring. Week 12. Formulation and Fill Finish Systems. DURATION DATE LOCATION DELIVERER 1 day theory, practical and assessment. Sat. Aug 6th CARRIGALINE KC 1 day theory, practical and assessment. Sat. Aug 13th CARRIGALINE KC ½ day – theory. Sat. Aug 20th CARRIGALINE AF CARRIGALINE UQ Lyophilisation Systems. ½ day – theory. Week 13. Course Revision. 1 day – theory revision. Sat. Aug 27th Week 14. Course Assessment. 1/2 day theory exam. Sat. 3rd Sept CARRIGALINE UQ 4