DUBLIN–(BUSINESS WIRE)–The “Biotechnology
for the Non-Biotechnologist” conference has been added to ResearchAndMarkets.com’s
offering.
Biotechnology for the Non Biotechnologist, ideal for non-Scientists and
Scientists who need to understand the basic theory, principles,
techniques, and potential of biotechnology.
Course Overview
This intensive three-day course is ideal for non-scientists and
scientists needing to understand the basic theory, principles,
techniques and potential of biotechnology.
You will gain an overview of how biotech products are being developed
and manufactured, and discuss the scientific and regulatory environment.
The latest advances in regulation will be covered, including biosimilars
and advanced therapies. The course will also discuss the role and
importance of patents within biotech, including what actually can be
patented.
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:
The course has been designed for those working in:
- Quality assurance
- Regulatory affairs
- Legal and IP
- Business development
- Sales and marketing
- Engineering
- Finance
- Clinical
- Training
- Project management
Agenda:
Day One
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
General discussion
Day Two
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
General discussion
Day Three
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
General discussion
For more information about this conference visit https://www.researchandmarkets.com/r/cujq9w
Contacts
ResearchAndMarkets.com
Laura Wood, Senior Press Manager
press@researchandmarkets.com
For
E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call
1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related
Topics: Biotechnology