There are a number of factors that need to be considered when developing a manufacturing process for vaccines that will be acceptable to regulatory authorities. Careful planning of the development and scale-up of the manufacturing process can avoid problems at later stages. This planning, combined with an overall regulatory strategy, can add value to a product and increase attractiveness to potential investors or partners.

This audio conference discusses the requirements for different types of vaccines, requirements at different stages of development, problems associated with scale-up and process change, as well as differences in requirements in the USA and Europe.

This audio conference covers:

• Regulatory expectations for different types of vaccine
• Regulatory expectations for different stages of development
• How to plan process change and scale-up
• Differences in USA and Europe requirements
• The importance of a well planned regulatory strategy

About the speaker:

David Kirke is an Associate Director at ERA Consulting (UK) Ltd. and specializes in quality (CMC) aspects of biological products, particularly vaccines. His responsibilities include compilation of marketing authorisation applications, investigational medicinal product dossiers, scientific advice procedures, orphan drug applications, gap analyses and regulatory strategy planning as well as general consulting on biological processes and European regulatory affairs. Before joining ERA David gained thirteen years of experience in research, including six years working in biological process development, scale-up and technology transfer in the biopharmaceutical industry. He has experience with a wide range of biotech processes including conventional and recombinant vaccines (viral and bacterial), bacterial expression systems, yeast expression systems, cell culture systems and DNA vaccines.

David completed a PhD and post doctoral studies in Molecular Microbiology at the School of Pharmaceutical Sciences, University of Nottingham, before moving to the biotech industry. He spent three years at Phico Therapeutics developing a commercial process for production of recombinant bacteriophages then moved to Schering-Plough where he worked on development and scale-up of production processes for vaccines. He joined ERA consulting in early 2008.

Who should attend?

• Cheif Executive Officers
• Chief Scientific Officers
• R&D Scientists
• Regulatory Affairs
• Project Managers