539 Schedule

PME 539C Schedule – Fall 2009 Bioprocess Technology in Pharmaceutical Manufacturing

Lecture Date

Topic

Reading Assignment

Discussion

1

9/4

Introduction to bioprocess technology

Text: ch. 2 & pp.180183

Introductions & Orientation

2

9/11

Fermentation and cell culture

Text: ch. 1, 2

Group 1

3

9/18

Harvest and clarification: centrifugation, micro- and depth filtration

Text: ch. 3, 4

Group 2

4

9/25

Filtration processes Ultra-, diafiltration, viral clearance, sterilizing filtration.

Text: ch 4, 9

Group 3

5

10/2

Chromatography systems

Text: ch 5

Group 1

6

10/9

Auxiliary process operations media and buffer preparation

To be assigned

Group 2

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-InPlace, Clean-Out of-Place)

Text: ch 12

Group 1

9

11/6

Sterilization of Equipment, Piping and Process Fluids

Text: ch 13, 16

Group 2

10

11/13

Design of process equipment and piping; cGMP & BPE guidelines

Text: ch 7

Group 3

11

11/20 Biopharmaceutical manufacturing facility

Text: ch 8, 17, 18

Groups 1 & 2a

Text: ch 21

Groups 2b & 3

12

11/27

No class

12/4

Validation: basics, equipment and

facility qualification 12/11

Term paper presentations

12/18

Final Exam

Term paper due Term paper presentations Lecture material 7-12