International organizations have reported on a worldwide shortage of manufacturing facilities for vaccines.  

The aim of this colloquium is to improve those statistics.

Manufacturing today’s vaccines involves adherence to regulatory requirements, appropriate facility design, a clear results-oriented process, quality control, validation, and adequate funding to drive the entire operation. At the Manufacturing Vaccines Colloquium, experts will share their insights and real-life experiences of the manufacturing process to help you plan for and manage your vaccine development projects.

Professionals working in vaccine production and facility operations will outline the numerous details comprising the manufacturing process, and will share advice to help vaccine developers with the goal of heading into the manufacturing phase.

Expert presentations will be combined with ample discussion to maximize the networking experience and enhance information sharing.


Topics will include:

Process Design & Development

• Design process & set up team
• cGMP from an industry perspective – real-life experiences
• Analytical process
• product release, 
• characterization, and 
• monitoring through the life cycle (early product development through launch) 
• Documentation and procedures 
• Personnel training and documentation of training
• Scale-up challenges 
• Implementing process improvements

Facility Design Considerations 

• Capacity 
• Balance between time to market and timing to spend capital 
• Facility requirements for bulk product vs. sterile operations (formulation, filling, etc.) 

QC Monitoring / Testing 

• Raw materials, e.g. supplier auditing for quality and consistency
• Environmental monitoring 
• Product stability 
• Bulk vs. sterile operations
• Investigations into manufacturing deviations and change control 

Validation 

• Traditional areas: cleaning, sterilization, process 
• Container closure validation 
• Computer system validation 
• Expectations for demonstrating consistency

Final Product Considerations 

• Packaging
• Shipping 
• Testing on importation

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

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

Deadline for submitting a proposal: March 9, 2007

Click here to submit a proposal

For more information, please contact:
Mary Ruberry, Conference Director
Phone: 781-972-5421 • E-mail: mruberry@healthtech.com