Most vaccine facilities are multi-product, and will be used to manufacture products other than the one(s) originally forecasted to support known product lines.

New vaccine facilities and their operations must be flexible and adaptable to accommodate new products effectively in both the short and long-term. Clearly, projects must be cost-effective to design, construct and operate in both schedule and cash flow.

Facilities must be able to turn around for new campaigns quickly or, if necessary, be retrofi tted for new products with minimum downtime. However, there are rational limits that should be recognized and evaluated to determine the best value for a particular project or scenario.

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This masterclass will provide an overview, specific scenarios and several case studies covering areas such as:

• Vaccine facilities design, approaches and prioritization of facility capabilities
• Successful approaches and specifi c tools to be utilized in projects
• Innovative approaches for facility fl exibility
• Effective designs by interactive design teams and tools
• Trends in the future facility designs and capabilities from emerging market demands

• Vaccine Facility Design Professionals
• Vaccine Operations and Professionals
• Production and Engineering Professionals
• Validation and Quality Experts
• Regulatory Affairs Professionals
• Planning and Risk Management Professionals

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Regulation is an issue faced by all vaccine developers at different stages of the development process. New manufacturing methods and technologies for developing new and/or improved vaccines, present unique challenges to National Regulatory Authorities.

There are also challenges evaluating the manufacturing as well as the clinical outcomes of vaccines made with these new technologies. Can these technologies be scaled-up, are the resulting products manufactured consistently from lot to lot; are they stable? What endpoints do we use to evaluate these vaccines in the clinic for safety and effi cacy? Are there special safety concerns that must be considered when evaluating the risk versus benefi t of these new vaccines? Which strategy to follow for registering vaccines from developing countries into developed countries?

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This masterclass is dedicated to the regulatory issues within vaccine development and will look at areas such as:

• Scientific and regulatory overview of EMEA Guidelines
• Quality control of cell substrates and vaccines
• Analytical strategy for vaccines: what technique to use?
• Effective development and validation of biological potency assays
• Risk management strategies
• Assembling a vaccine marketing authorization dossier

• Regulatory Affairs Professionals
• Clinical Development Scientists
• Formulation Chemists
• Analytical Scientists
• Quality Control Professionals
   

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