1: Introduction to Biopharmaceuticals

• Biopharmaceutical molecules
• Protein structure and properties
• Pharmacokinetic manipulations
• Immunogenicity
• Recombinant expression
• Gene and cell therapy 

2: Biostatistics

• Introduction to Statistics
• Methods of Data collection, Organization and presentation
• Summarizing data
• Demographic Methods and Health Services Statistics
• Sampling methods
• Estimation
• Hypothesis Testing
• Correlation and Regression

3: Concept of Pharmacokinetics and Pharmacodynamics

• Basic pharmacodynamic concepts
• Therapeutic drug monitoring
• Pharmacokinetic models
• Plasma drug concentration versus time curves

4: Protein Purification Processing

• Choosing the Right Protein Purification Strategy
• Affinity Tags
• Protein:Protein Interaction Analysis: In Vivo and In Vitro Methods
• Analysis of DNA:Protein Interactions
• Immunoassays: ELISA and Western Blot Analysis
• Mass Spectrometry Analysis 

5: Biopharmaceutical Manufacturing Facility

• Introduction
• Biopharmaceutical manufacturing process
• Key points in designing cultivation equipment
• Key points in designing purification equipment
• Optimization of bioprocesses using pilot scale facilities

6: Enzyme Technology and Biocatalysis

• Introduction to Enzyme Technology
• Basics of Enzymes as Biocatalysts
• Enzyme Discovery and Protein Engineering
• Enzyme Production and Purification
• Application of Enzymes in Solution: Soluble Enzymes and Enzyme Systems
• Immobilization of Enzymes (Including Applications)
• Characterization of Immobilized Biocatalysts
• Reactors and Process Technology

7: Biovalidation Research Methods

• Introduction (background) and Scope
• Legal basis
• Method validation
• Analysis of study samples
• Incurred samples reanalysis
• Ligand Binding Assay
• Reports

Introduction of Vaccine

• The History of Vaccination
• Immune System
• Overview of Vaccine
• Components of a vaccine
• Clinical Evaluation of Vaccine
• Government Schemes for Vaccination
• Vaccine Hesitancy

2: Types of Vaccine

• Whole-cell inactivated vaccines
• Protein subunit vaccines
• Recombinant vaccines
• Polysaccharide and conjugate vaccines
• Nucleic acid-based vaccines (mRNA vaccines)
• Viral vector vaccines
• Toxoid vaccines

3: Vaccine manufacturing process

• Upstream
• Downstream
• Formulation

4: Production and quality control of vaccines

• Prevention of cross-contamination in production
• Starting materials
• Media
• Seed lot and cell bank system
• Operating principles
• General rules for veterinary medicinal products including vaccines
• Good practice for quality control in laboratories
• Batch tests for immunological products

8. Scientific Communication and Research Skills

• Theory:
  • Writing research papers and grants
  • Presentation skills and conference etiquette
• Practical:
  • Preparing and presenting research findings
  • Peer review and feedback sessions

9. Project Work II

Practical