Chapter 3

10.491 Spring 2012ICE BATCH PROCESS DESIGN V 23/14/2012

DATETOPICREADINGDUE

Feb 7 (T)1. Intro to 10.491 and Systems Thinking

Feb 9 (R)2. Biotech and pharmaceutical industry context

Feb 10 (F)3. Project Team meeting Team Rpt.

Feb 13 (M)4. Platform Technology and Product Life Cycle

Feb 14 (T)5. MAB Market Analyses and Forecast

Feb 16 (R)6. Business &Process economics

Feb 17 (F)7. Batch process design & flow sheet synthesisPS 1

Feb 20(M)8. Holiday - No Class

Feb 21 (T)*9. Intro to SuperPro Designer (D. Petridis)

Feb 23 (R)*10. Intro to SuperPro Designer (TA Consultation)

Feb 24 (F)*11. SuperPro Designer (Q&A session, D. Petridis)PS2

Feb 27 (M)12. Bioreactor kinetics and design

Feb 28 (T)13. Aseptic design and validation (J. Leung)

Mar 1 (R)14. Bioreactor kinetics and design

Mar 2 (F)15. Media designPS3

Mar 5 (M)16. Media and air sterilization

Mar 6 (T)17. Centrifugation

Mar 8 (R)18. Membrane filtration

Mar 9 (F)19. Membrane filtrationPS4

Mar 12 (M)20. Chromatography

Mar 13 (T)21. Chromatography

Mar 15 (R)22. Chromatography

Mar 16 (F)23. Intro. To Drug Regulations (J. Leung)

Mar 19(M)24. Quality Operations (J. Leung)PS5

Mar 20 (T)25. Project management and planning (J. Leung)

Mar 22 (R)26. Assessing uncertainty in design

Mar 23 (F)27. Single-Use Technology

Mar 26 (M)No Class Spring Break

Mar 27 (T)No Class Spring Break

Mar 29 (R)No Class Spring Break

Mar 30 (F)No Class Spring Break

Apr 2 (M)28. Scheduling and Debottlenecking PS6

Apr 3 (T)29. Drug product formulation (J. Leung)

Apr 5 (R)30. Portfolio Assessment (C. Pritchard)

Apr 6 (F)31. Risk Register and ManagementPS7

Apr 9 (M)32. Review and Consultation

Apr 10 (T)33. Review and Consultation

Apr 12 (R)34. Review and Consultation

Apr 13 (F)35. Review and ConsultationFinal Report

*Guest Lecturer: Dr. Demetri Petridis, Intelligen, Inc.

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