Biotechnology for the Non-Biotechnologist Training Course: Latest Advances in Regulation, Including Biosimilars and Advanced Therapies (ONLINE EVENT: June 24-28, 2024/On-Demand)
Tuesday, 18 June 2024
Dublin, June 18, 2024 (GLOBE NEWSWIRE) -- 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
*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
*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
*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.
*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.
*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.
*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.
*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.
For more information about this conference visit https://www.researchandmarkets.com/r/gac498
*About ResearchAndMarkets.com*
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