Introduction:

Biotechnology, 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.

This five-day course will provide an overview of how biotech products are being developed and manufactured, and discuss the scientific and regulatory environment. The interactive programme 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

Objectives:

• 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…?

This course is ideal for non-scientists and scientists needing to understand the basic theory, principles, techniques and potential of biotechnology.

Course Outlines:

Day 1

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

Day 2

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

Day 3

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?

Day 4

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

Day 5

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