GENE529 PHARMACEUTICAL BIOTECHNOLOGY
| Course Code: |
2190529 |
| METU Credit (Theoretical-Laboratory hours/week): |
3(0-0) |
| ECTS Credit: |
8.0 |
| Department: |
Molecular Biology And Genetics |
| Language of Instruction: |
English |
| Level of Study: |
Graduate |
| Course Coordinator: |
|
| Offered Semester: |
Fall and Spring Semesters. |
Course Content
Provides connection between the biological sciences involved in the study of cellular system at the molecular level and the technological developments involved in exploiting rDNA technology and presenting the active material as a pharmaceutical product. Upstream and downstream processes, methods for analyzing and characterization of new generation drugs including their purity, stability and formulation are covered. Particular attention is placed on the method and process validation. The rules governing rDNA technology derived medicinal products in European Community, current good manufacturing process (cGMP) and current good laboratory practices (cGLP) for the product manufacturing in the pharmaceutical industry are also included.
