Course Details
Course Outline
5 days course
Introduction to Biotechnology
- Historical perspective
- Diversity of biotechnology products
- Impact on society
- Product development overview
Introduction to Molecular Biology
- DNA, RNA, genes, plasmids and vectors
- Protein synthesis – transcription and translation
Re-expression of proteins
- Recombinant DNA techniques
- Monoclonal antibodies – from mouse to human
- Transgenic animals and plants
Development of Production Organisms
- Transfection
- Selection
- Preservation
Fermentation Technology and Large-Scale Production
- Types of fermenters
- Fermentation basics
- Modes of operation
- Process development
Process Optimisation and Scale-up
- Scale-up strategies
- Strain improvement
- Media improvement
- Process improvement
Analysis of Biopharmaceuticals
- Biological activity
- Physicochemical characterisation
- Purity, impurities and contaminants
Product Recovery and Purification
- Cell harvesting and removal
- Clarification – intracellular and extracellular proteins
- Chromatographic techniques
Formulation Design of Biopharmaceuticals
- Factors affecting degradation
- Choice of excipients
- Prolonging shelf life
Process Economics
- Drug development and bioprocess economics
- Optimising bioprocess economics
- Manufacturing make or buy
- Future manufacturing alternatives
Patenting Biotech Inventions
- What is a patent?
- What are the basic criteria for patentability?
- What can be patented?
- Can you patent genes, proteins, hybridomas, and stem cells?
Patent Workshop
- How to recognise what is patentable
- Drafting claims to biotech inventions
- Maximising protection for an invention
- Understanding the examination process
- Enforcing patents
Regulatory Considerations of Biopharmaceuticals
- General principles
- Product quality and control
- Pre-clinical safety
Application of Regulatory Principles
- What do regulators want?
- Specifications
- Product characterisation
- Assessment of process change
- Comparability guidance and strategy
Advances in Regulation: Biosimilars
- Comparability, equivalence and biosimilarity
- Biosimilars guidance
- Guidance vs practice – a case study
Advances in Regulation: Advanced Therapies
- Gene therapy
- Cell therapy
- Tissue-engineered products
