In-depth research has revealed that vaccine manufacturers are faced with a wide range of challenges including the need for flexibility and versatility, management of scale-up and process change, and the consequent necessity for ensuring product consistency and obtaining regulatory approval.

Advances are being made in upstream and downstream processing and also in characterizing the vaccine after process change implementation. 

At this event delegates will learn from the experts how to take advantage of improved manufacturing technology, how to control and monitor product consistency, and how to save time and expense with their regulatory dealings. 

I am looking for speakers for in-depth, case-driven talks on the following and related topics: 

Scale-Up and Rapid Response to Pandemics

• Achieving flexibility in capacity / measures to speed up the reaction to a pandemic
• Scale-up of production from bench to commercialization

Process Optimisation for Vaccine Manufacture

• Determining specifications of the process
• Advances in purification technology
• Designing and validating a manufacturing process
• Maintaining sterility during production
• Managing aggregation
• Measures to reduce cost of goods
• Case study on vaccine production with particular cell lines
• Benefits of manufacturing vaccines in the developing world

Quality Issues and Comparability

• Benefits of Quality by Design for maintaining quality and potency of the product and for risk analysis
• Release and change control assays to ensure consistent antigen and product characteristics / comparability
• Advances in analytical technologies for characterizing the produc
• Potency assays that correlate with protection as part of a change control exercise

Working with the Regulatory Authorities

• Experiences of handling the regulatory requirements regarding vaccine manufacturing and implementing change

Single Use Systems (Disposables) for Vaccine Manufacture

• Analysis of the pros and cons of disposables and conventional methods
• Regulatory authority experiences regarding the use of single use systems
• Example of how single use systems lend themselves to the management of multi-product facilities
• Application of single use systems for pandemic preparedness or for biodefence vaccines

If you would like to give an oral presentation at this conference, please submit a proposal including a title and brief summary about your recent work in the area of Production & Manufacturing of Vaccines.

All proposals are subject to review by the Scientific Advisory Committee to ensure the overall quality of the conference.

If you are interested in presenting, please click here to submit a speaking proposal for review. 
Deadline for submission is February 12, 2010

Nicole Lyscom
Conference Producer
Cambridge Healthtech Institute
Phone: +44 7791 866489
Email: nlyscom@healthtech.com 

For partnering and sponsorship information, please contact:
Suzanne Carroll
Manager, Business Development
Cambridge Healthtech Institute
Phone: 781-972-5452
Email: scarroll@healthtech.com