DUBLIN–(BUSINESS WIRE)–The “Biotechnology for the Non-Biotechnologist Training Course” conference has been added to ResearchAndMarkets.com’s offering.
This intensive three-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.
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.
Benefits of attending:
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.
It will be relevant for anyone needing either an overview or refresher, particularly those working in:
Quality assurance
Regulatory affairs
Legal and IP
Business development
Sales and marketing
Engineering
Finance
Clinical
Training
Project management
Key Topics Covered:
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
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
Product Recovery and Purification
Cell harvesting and removal
Clarification – intracellular and extracellular proteins
Chromatographic techniques
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
For more information about this conference visit https://www.researchandmarkets.com/r/7mdphb
Contacts
ResearchAndMarkets.com
Laura Wood, Senior Press Manager
[email protected]
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