Biotechnology for the Non Biotechnologist, ideal for non-Scientists and Scientists who need to understand the basic theory, principles, techniques, and potential of biotechnology
26-28 Sep 2018
& 10-12 Apr 2019
Join this extensive three-day training course to gain a thorough understanding of the fundamental principles of Biotechnology to deepen your knowledge of the key techniques used by Bio-technologists. It will show you the importance of meeting regulatory requirements along with the advances being made. You will also learn how to identify potential patents, as well as why and how they must be protected.
Introduction to Biotechnology
Introduction to Molecular Biology
Re-Expression of Proteins
Development of Production Organisms
Fermentation Technology and Large Scale Production
End of Day One and Drinks Reception
Process Optimisation and Scale-Up
Analysis of Biopharmaceuticals
Product Recovery and Purification
Formulation Design of Biopharmaceuticals
Patenting Biotech Inventions
Regulatory Considerations of Biopharmaceuticals
Application of Regulatory Principles
Advances in Regulation: Biosimilars
Advances in Regulation: Advanced Therapies
Mark Richardson (26-28 Sep 2018)
Mark Richardson is a Pharmaceutical/Biotech Drug Development Regulatory Affairs Consultant and is also Director of Richardson Associates Regulatory Affairs Ltd. After postdoctoral research in molecular biology at the Universities of Dundee and California at Berkeley, he joined British Biotech in 1988 to work on recombinant vaccines before becoming Head of Assay Development, then Biopharmaceutical Development Manager and subsequently moving into Regulatory Affairs with responsibility for rDNA products in preclinical and clinical development.
In 1997 he moved to Groupe Fournier as Head of the Gene Therapy Development Unit to lead a European oncology clinical development programme. Joining the CRO sector in 1999, first with Orion Clinical Services and later with i3 Research, he headed the Regulatory Affairs departments providing advisory and regulatory support for global development and clinical investigation of gene and cell therapy products, recombinant proteins and monoclonal antibodies, as well as for small molecule drugs.
Philip Webber (26-28 Sep 2018)
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.
Kate Smith (26-28 Sep 2018)
Kate Smith is currently Principal Scientist, Development Services, at BioReliance, UK, part of the Merck Group. In this position she is reponsible for providing technical supprt to both colleagues adn clients on the deign, execution and interpretation of viral clearance studies. Prior to transitioning into Development services Kate was responsible for managing the team involved in the preparatino of cell banks, viral seeds stocks and production of clinical lots of virus. .
Prior to joining BioReliance Kate was a Principal Group Leader in the Purification Development Group at Lonza Biologics, plc. She has more than 18 years experience in the development, scale-up, transfer and validation of purification processes for monoclonal antibodies and recombinant proteins from mammalian cell cultures. Her area of expertise is the design and management of Viral and DNA reduction studies used to support product safety.
Alison Sykes (26-28 Sep 2018)
Alison Sykes is Director Physico-Chem Analytics, for Fresenius-Kabi, SwissBio Sim, a post she took up in 2017. She was formerly a Director within the Biosimilar Unit of Merch Serono and Biosimilar Technical Director within Analytical Services at Lonza Biologics plc responsible for oversight and definition of all analytical activities relating to pre-clinical and clinical development of Biosimilars derived from mammalian and microbial cell culture. She had worked for Lonza for 25 years, responsible for running various different analytical teams and functions including cell culture support, method development and validation, stability and formulation and protein characterisation. She has been responsible for set-up and establishing FDA and MHRA approved laboratories and providing technical and advisory support for CMC development of biopharmaceuticals from pre-clinical through to clinical phases, including several successful BLA licence applications. A biochemist by training, she started her career working for the National Health Service and then moved to NIBSC. Her experience here on the human side of the drug industry and the need for global standards in protein drug development helped drive her enthusiasm for detailed analysis and characterisation of safe and efficacious biopharmaceuticals.
Adekunle Onadipe (26-28 Sep 2018)
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. He 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, he has been involved in the production of biopharmaceuticals for more than 27 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.
Peter O'Callaghan (26-28 Sep 2018)
Peter O’Callaghan holds BSc and PhD degrees in Genetics from Newcastle University. Since graduation he has gained over 10 years’experience in biotechnology research and development in academia and industry, during which time he co-authored patents as well as research articles and reviews in international peer-reviewed scientific journals and books.
Since 2011 he has been woking in the New Expression Technologies group at Lonza Biologics in Cambridge. He works as an Associate Principle Scientist where he leads efforts to develop new technologies for the industrial synthesis of antibody-based biotherapeutics.