Bridging Vaccine Translational Research

Interest in vaccines has never been greater, as shown by substantial high-profile private and public investment in the sector. For example, the market for vaccines for children and adolescents, is estimated to grow from $4.3 billion in 2006 to $16 billion by 2016 (1). Product development service providers, including contract manufacturing organisations (CMOs), can bridge vaccine translational research, enabling sponsors to rapidly develop and access new vaccines during early-stage clinical trials.

Many companies developing vaccines, unlike biotech companies developing monoclonal antibody products, need to make considerable capital investment in establishing their own manufacturing facilities, often at a time when capital is required to support clinical development. Table 1 shows a selection of top-tier biotechs that are developing vaccines and have established internal manufacturing capability.

This trend reflects, in part, the unique process and analytical challenges faced in developing each new vaccine, when compared to the platform approach that is more readily adopted for monoclonal antibody products (MABs). This article focuses on process design issues for the development of vaccines, comparing current commercial, technical and regulatory trends with the issues faced by companies developing highly characterised monoclonal antibodies.

RAPIDLY EXPANDING MARKET OPPORTUNITIES FOR BIOTECHS DEVELOPING VACCINES

The adage that ‘prevention is better than cure’ has been the basis for substantial interest in vaccines over the past few years from:

• Governments
• Pharmaceutical companies
• Not-for-profit organisations

For governments struggling with rising healthcare costs, vaccines represent a cost-effective investment: for preventing illness; for government personnel rapidly mobilised for overseas operations; for use against pandemics, such as influenza; and more recently for preventing cancers caused by viral infections