Week 12: Final product analysis: Protein based contaiminants
Chapter 7: Product Analysis. Page: 173 to 185
We studied about the introduction of this chapter and discussed that how the protein based impurities are detected by Quality control (QC) team and at which stages these can be removed during drug development process.
Moreover, The estimation of drug potency was also also discussed.
Various methods for the detection of durg potency and protein based contaiminants was studied
Course Material
- Week 1: Introduction to Pharmaceutical Biotechnology
- Week 2: Drug development process and properties of effective drug
- Week 3: impact of genomics and other technologies upon drug discovery
- Week 4: Functional Genomics, Pharmacogenomics, routes of drug administration
- Week 5: Lab scale studies, pre clinical studies and drug toxicity
- Week 6: clinical trails, role of regulatory authorities, legal and regulatory issues
- Week 7: Sources of recombinant proteins (drugs)
- Week 8: Upstream processing for production of biopharmaceutical
- Week 9: Recovering the recombinant protein at manufacturing scale
- Week 10: purification of biopharmaceutical
- Week 11: Final product formulations and its processing
- Week 12: Final product analysis: Protein based contaiminants
- Week 13: Final product analysis: Non protein based contaiminants
- Week 14: Analysis of Biopharmaceutical and validation studies
- Week 15: Polymers used in pharmaceutical industory and controlled drug release systems
- Chapters 15
- Department Biotechnology
- Teacher
Mrs. Misbah Hussain
