Week 14: Analysis of Biopharmaceutical and validation studies
Chapter 7: Product Analysis. Pages: 185 to 189 and 199 to 201
We studied about the analysis of recombinant protein (Biopharmaceutical).
- Amino acid analysis
- Peptide mapping
- N-terminal sequencing
- Analysis of secondary and tertiary structures.
Moreover, we also studied about the validation protocols or practices (Good manufacturing practices) which the pharmaceuticall indusories carry out the make their manufacturing unit running in good condtions and to reduce the batch to batch variation.
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
