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 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
Agenda
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
Product recovery and purification
- Cell harvesting and removal
- Clarification - intracellular and extracellular proteins
- Chromatographic techniques
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?
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
Speakers
Adekunle Onadipe,
Pfizer Inc.Dr Adekunle Onadipe is an Associate Research Fellow in Bioprocess R&D, Cell Line Development at Pfizer Inc. USA. He leads a group of scientists responsible for the construction, development and characterization of mammalian and microbial cell lines for biotherapeutics and vaccines production. His group is also involved in the scale-up of bioprocesses from bench top to pilot scale bioreactors and process development for the establishment of cell banks to support the manufacture of biopharmaceutical products for early phase clinical trials.
Kunle joined Pfizer Limited in the UK in 2005 in Discovery Biology with responsibility for optimizing cell culture processes for the production of cell-based assay reagents. Prior to this he worked for 15 years at Lonza Biologics plc., in Slough UK where, as a Principal Group Leader in cell culture process development, he was responsible for constructing and developing production mammalian cell lines and culture processes, subsequently transferring them to full-scale production for clinical trials.
A microbiologist by training, Kunle has been involved in the production of biopharmaceuticals for more than 30 years and has a broad experience of microbial and mammalian cell culture methods. He obtained his PhD in Microbiology from the University of Surrey, Guildford UK.
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
Location
ADDRESS
Rembrandt Hotel
11 Thurloe Pl,
Kensington
London
SW7 2RS
United Kingdom
DIRECTIONS
The Rembrandt Hotel is located at 11 Thurloe Place, London, SW7 2RS. The hotel’s location in central London couldn’t be better, whether you’re travelling for business or leisure. You’ll be right between two of London’s most fashionable areas – South Kensington and Knightsbridge – within walking distance of museums, theatres, Harrods and Hyde Park.
You can hop on the Tube at South Kensington and take the District, Circle or Piccadilly lines direct to the City of London, Heathrow Airport and all other areas of the city. Look out of your window and you may well see the Victoria and Albert Museum – it’s right across the street.
