Therapeutic Protein Production

About the chair

Brendan Fish is Director of New Product Introduction and Process Technology for GSK at Barnard Castle. With a career spanning over 20 years, he was Director of Bioprocess Sciences at MedImmune Cambridge where he was responsible for all aspects of the development of purification methodologies, product characterisation, QC, formulation and delivery for MedImmune products in relation to their use in commercial pharmaceutical processes. This included initial design and optimisation, scale-up, process cost modelling, process integration and technology transfer to GMP Production for clinical trial supply. Brendan was also at Delta Biotechnology Limited as a Consulting Scientist. He played a key role in the development of their biotechnology-based products providing expert opinion and strategies for QA, QC, Production, Marketing, Operations, Regulatory Affairs and Engineering on all aspects of Process Development. Early in his career, he was a Post-doctoral fellowship at University of Toronto in Canada working in the School of Nutritional Sciences, studying the anti-nutritional effects of lectins in the diet.

About the speakers

Philip Mellors is responsible for Eden Biodesign’s in house upstream development programs and management of its outsourcing requirements. The upstream development group has capabilities in molecular biology, cell line construction (microbial and mammalian), fermentation development, scale up and transfer into Eden’s GMP facilities. The group is also responsible for upstream bioprocess characterisation and validation. Prior to joining Eden, Phil led the bioprocess development team at Renovo PLC and has held positions at Lonza Biologics, CellTech-Medeva. Phil graduated with an Applied Biology degree from the University of Coventry in 1997. 

Dr Gareth Lewis has over 11 years of experience of bioreactor process development. After completing his PhD at the University of Birmingham/AstraZenca in 2003, he joined MedImmune, formally known as Cambridge Antibody Technology, as a cell culture process development scientist. In his current role at MedImmune he leads a team of scientists working on manufacturing cell line selection and preclinical process development. Alongside his core responsibilities for process development, technology transfer and CMC, Gareth has developed a keen interest in scale-down cell culture systems to aid improved process development and cell line selection strategies.

Paul Dalby is a Reader in Biochemical Engineering and Biotechnology at UCL.  His research addresses protein engineering and biophysics challenges associated with bioprocess development, protein engineering and biopharmaceutical formulation.  He graduated from the University of Cambridge with a degree and PhD in protein folding and engineering with Sir Prof Alan Fersht, then worked at the University of Pennsylvania with Prof William DeGrado.

He is currently Chairman of the RSC Biotechnology Group. Awards include the 2008 Evonik European Science-to-Business Award, the 2010 IChemE Innovation and Excellence Award in Bioprocessing, and the 2010 RSC Rita and John Cornforth Award for teamwork.

Patrick Hole is currently Head of Development at NanoSight and has been with the company five years. Previously he has completed a PhD in optoelectronics at the University of Southampton and a Masters Engineering degree at Oxford Universtiy. He has focussed on developing both the hardware and software involved in the Nanoparticle Tracking Analysis (NTA) technique, invented eight years ago, to be an easy to use, accurate and robust system.

Stephen Thompson has over twelve years’ regulatory affairs experience in the pharmaceutical industry as a consultant, joining Origin Pharmaceutical Services (which then became Constella Group), before moving to S-cubed Ltd as Director of Regulatory Affairs in March 2009.  Stephen has provided regulatory support to many pharmaceutical and biotechnology companies in both Europe and the USA, and has worked with European regulatory agencies and the US FDA. His experience includes the preparation, submission and approval of clinical trial applications for clinical studies in the EU and USA, as well as marketing authorisation applications and subsequent maintenance, for both small molecules and biologicals. 

www.regonline.co.uk/protein2011