PME 539C Schedule – Fall 2009

Bioprocess Technology in Pharmaceutical Manufacturing

Lecture Date Topic Reading Assignment Discussion

 
1 9/4 Introduction to bioprocess Text: ch. 2 & pp.180- Introductions
technology 183 & Orientation
 
2 9/11 Fermentation and cell culture Text: ch. 1, 2 Group 1
3 9/18 Harvest and clarification: Text: ch. 3, 4 Group 2
centrifugation, micro- and depth
filtration
4 9/25 Filtration processes Ultra-, dia- Text: ch 4, 9 Group 3
filtration, viral clearance,
sterilizing filtration.
5 10/2 Chromatography systems Text: ch 5 Group 1
6 10/9 Auxiliary process operations - To be assigned Group 2
media and buffer preparation
 
  10/16 Midterm exam Lecture material 1-6  
7 10/23 Critical process utilities Text: ch 14, 16, 17 Group 3
8 10/30 Equipment Cleaning (Clean-In- Text: ch 12 Group 1
Place, Clean-Out of-Place)
9 11/6 Sterilization of Equipment, Piping Text: ch 13, 16 Group 2
and Process Fluids
10 11/13 Design of process equipment and Text: ch 7 Group 3
piping; cGMP & BPE guidelines
11 11/20 Biopharmaceutical manufacturing Text: ch 8, 17, 18 Groups 1 & 2a
facility
  11/27 No class    
12 12/4 Validation: basics, equipment and Text: ch 21 Groups 2b & 3
facility qualification
Term paper due
  12/11 Term paper presentations   Term paper
presentations
  12/18 Final Exam Lecture material 7-12