Vaccines Conference Workshops

As a scientific manager with experience in vaccine development from preclinical through commercial production, I will provide a perspective of the requirements and challenges of vaccine development and manufacturing. Vaccines differ as greatly as the diseases they are designed to prevent. Vaccines may be a live attenuated replicating or non-replicating virus, a protein or polysaccharide and be produced by bacteria, mammalian cells or even primary hosts such as eggs. While the product and processes used in manufacturing may be significantly different, many aspects of vaccine development and manufacturing are similar. A 30,000’ view of the challenges of vaccine development and manufacturing throughout the phases of product development will be discussed with presentation of some lessons learned.

• Successfully addressing cell line development issues
• Developing a preclinical strategy
• Solving manufacturing issues for clinical development
• Development of a process and mentality for process development documentation
• Successful technical transfer of a process into manufacturing

Richard M. Schwartz, PhD, Chief, Vaccine Production Program, Vaccine Research Center, NIAID, NIH

Indication-specific formulations require substantial manufacturing and analytical processes that are product-specific. IVT’s lead product, a peptide-based liposomal depot vaccine for prostate, breast and ovarian cancers, has been optimized for a phase 1 clinical trial. The challenges surrounding the readiness of the product for an IND application from a manufacturing and analytical chemistry standpoint will be discussed.

• Develop a scalable manufacturing process at the research level
• Implement the manufacturing process in a GMP facility
• Uncover what analytical tests you need today
• Tap into the regulator’s expectations for a first in man vaccine product

Marc Mansour, PhD, VP R&D, Imunovaccine Technologies Inc. (IVT)