Biotechnology for the Non-Biotechnologist
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Biotechnology for the Non-Biotechnologist Course
Introduction:
Biotechnology, is the use of biology to solve problems and make useful products. The most prominent area of biotechnology is the production of therapeutic proteins and other drugs through genetic engineering.
The importance of the biotech industry has increased significantly over recent years and biotech companies now dominate the new drug pipeline. The industry is gaining momentum and advancements in biomedical science and increased innovation hold vast potential for the growth of the biotech market.
Biotechnology for the Non-Biotechnologist training course will provide an overview of how biotech products are being developed and manufactured, and discuss the scientific and regulatory environment.
The interactive program will cover the latest advances in regulation, including biosimilars and advanced therapies, and address the role and importance of patents within biotech, including what actually can be patented.
Course Objectives:
Delegates attending Biotechnology for the Non-Biotechnologist training course will learn how to:
- Gain an introduction to the fundamental principles of biotechnology
- Improve your understanding of the key techniques used by biotechnologists
- Understand the key regulatory considerations for biopharmaceuticals
- Discuss advances in regulation – biosimilars and advanced therapies
- Learn how to identify potential patents, and why and how they must be protected
Who Should Attend?
Biotechnology for the Non-Biotechnologist course is ideal for:
- Non-scientists and scientists need to understand the basic theory, principles, techniques, and potential of biotechnology.
Course Outlines:
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 Optimization and Scale-up
- Scale-up strategies
- Strain improvement
- Media improvement
- Process improvement
Analysis of Biopharmaceuticals
- Biological activity
- Physicochemical characterization
- 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
- Optimizing 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 recognize what is patentable
- Drafting claims to biotech inventions
- Maximizing 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 characterization
- Assessment of process change
- Comparability guidance and strategy
