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
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
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
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.
Adrian Haines
Swedish Orphan Biovitrium SA (Sobi)
Dr Adrian Haines is a Senior Process Manager within MSAT at Sobi (Swedish Orphan Biovitrum). Adrian has extensive experience in generating mammalian cell lines suitable for the GMP production of biologics and is extensively involved in the scientific oversight of both upstream and downstream process development, and process characterisation studies prior to regulatory filings. He joined the company (then Novimmune, Switzerland, subsequently acquired by Sobi) in 2015 and prior to this he worked at Lonza Biologics in the UK working on projects to develop new technologies and processes for generating manufacturing cell lines. Before that he worked for ML Laboratories/Cobra Research developing UCOE technologies for the expression of proteins in mammalian cells and at Therexsys Ltd, developing antibody targeted gene therapies. Prior to this he worked at Celltech Research Ltd, generating radiolabelling and cross-linking technologies for antibodies. A biochemist by training, he has been involved in the protein chemistry and production of monoclonal antibodies ~30 years, starting with his PhD where he generated monoclonal antibodies (using hybridoma technology) for the diagnosis of prostate cancer. He received a biochemistry degree from Imperial College, London, and his PhD from St Thomas’ Hospital Medical School, University of London. He is currently based in the UK.
Robert Alvarez
Lonza Biologics Plc
After completing his degree in molecular biology at the University of Reading, Robert Alvarez has been at Lonza Biologics for 17 years, of which 14 were spent working in the product stability group and 2 as Head of Business Planning and Innovation within Analytical Services (AS). Most recently he has accepted a new role as Site Head of Digital Transformation spearheading Lonza’s digitilisation strategy. Within AS he was a Subject Matter Expert responsible for the design and implementation of forced degradation and formulation studies, directing stability programs for multiple products and establishing standards for stability, as well as supporting stakeholders and customers. As analytical lead for mAb and non‑mAb programs, he has provided technical and advisory support for CMC development of biopharmaceuticals from pre-clinical through to clinical phases, including successful BLA licence applications.
Rhydian Howells
ProPharma Group
Rhydian Howells, associate director of regulatory affairs at Diamond Pharma services a Propharma group company. 20 years’ experience in the industry, 10 years at a large contract manufacturer developing manufacturing processes and analytical offerings for biological products followed by 10 years in regulatory CMC roles supporting clients with clinical development and marketing authorisation activities for large molecules and advanced therapies.
Marc Feary
Lonza
Marc Feary is Principal Scientist at Lonza. He has greater than 15 years’ experience in biopharmaceutical development and bioproduction, having held R&D and commercially-focused roles at Lonza Biologics facilities in Slough and Cambridge (UK). Marc holds a B.Sc. in Human Biological Sciences from Plymouth University and Ph.D. in Molecular Biology from the University of Kent.
Mardon McFarlane
Taxo Bioscience
Mardon McFarlane is a co-founder of a consultancy, Taxo Bioscience, that specialises in supporting pre-clinical and clinical stage biotech companies, by ensuring they make the correct, impactful decisions early in their journey to bring life-changing therapies to patients. Mardon specialises in the CMC aspect of drug discovery and has been involved in notable drug approvals during his 17+ years in the industry. His experience in the biotechnology sector started with biologics but over the last 10+ years he has migrated to the cutting-edge sector of cell and gene therapy. Mardon’s career has been focused on the processing aspects of drug manufacture and has spanned process development, technology transfer, scale up and large-scale manufacturing. Mardon holds an MEng in Biochemical Engineering from University College London.
Philip Webber
Dehns
Dr. Philip Webber obtained his first degree from Cambridge University, UK (Natural Sciences, Genetics) and then carried out research on the regulation of brain-specific genes at Warwick University, UK, where he obtained his PhD.
He qualified as a UK Chartered Patent Attorney and European Patent Attorney with Dehns (formerly Frank B. Dehn & Co.) London and Oxford, and is now a partner in their Life Sciences Group. He has a worldwide client-base including clients from the UK, Scandinavia, the US and Japan. Amongst other things, his work involves the preparation and filing of patent applications in Europe and throughout the world; acting for his clients in opposition procedures at the European Patent Office; and searching for and advising his clients on the relevance of competitors’ patents. He is an active member of the Life Sciences Committee of the UK Chartered Institute of Patent Attorneys (CIPA). He has spoken at a number of European conferences and on BBC Radio on the patenting of biotech inventions, as well as publishing a number of papers in this area.
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
