Dublin, Nov. 07, 2024 (GLOBE NEWSWIRE) -- The "Biotechnology for the Non-Biotechnologist Training Course" has been added to ResearchAndMarkets.com's offering.
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 intensive 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.
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
Certifications:
- CPD: 18 hours for your records
- Certificate of completion
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
Course 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
- RecombinantDNAtechniques
- Monoclonal antibodies - from mouse to human
- Transgenic animals and plants
DAY TWO
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
DAY THREE
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
DAY FOUR
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
DAY FIVE
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
Course Speakers
- Adekunle Onadipe, Pfizer
- Adrian Haines, Swedish Orphan Biovitrium SA (Sobi)
- Robert Alvarez, Lonza Biologics
- Rhydian Howells, ProPharma Group
- Marc Feary, Lonza
- Mardon McFarlane, Taxo Bioscience
- Philip Webber, Dehns
For more information about this conference visit https://www.researchandmarkets.com/r/l9bly0
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