Outsourced Vaccine Development

The authors discuss how strategic outsourcing to contract manufacturing organizations that have technical and regulatory expertise can add further value during vaccine development.
Jul 02, 2009
Volume 33, Issue 7

The recent influenza A H1N1 / H5N1 outbreaks, as well as increased concern over biodefense, have dramatically raised public interest in vaccination to "front page" news. Together, these events are driving demand for rapid development of novel vaccines. In both the public psyche and around the board tables of large pharmaceutical companies, vaccines are undergoing somewhat of a renaissance.

Images and figure courtesy of Eden Biodesign, Inc.
In 2007, vaccines demonstrated significant market growth, outperforming most other sectors of the industry, predominantly due to the success of Merck's (Whitehouse Station, NJ) Gardasil and continued strong performance of Prevnar from Wyeth (Madison, WI). This growth and a market of approximately $16.3 billion in 2007 (with projections of a $100 billion market by 2024 based on a similar compound annual growth rate)(1) has attracted the attention of companies not traditionally associated with vaccines. The vaccine industry is at present an oligopoly, dominated by major players Merck, sanofi-aventis/pasteur (Paris), GlaxoSmithKline (GSK, London), Novartis (Basel,) and Wyeth (Pfizer). However, the high performing potential of vaccines now represents an attractive prospect for other large pharma companies with concerns over diminishing returns through their traditional pipelines.

In addition to corporate organizations, the cost effectiveness of vaccination rather than treatment is widely recognized by international health authorities. Further sources of funding from philanthropic organizations such as the Bill and Melinda Gates Foundation have boosted the development and availability of pediatric vaccines in developing countries. Likewise, there continues to be high levels of biodefense funding for vaccine research and development (2).

Figure 1: Biotechnology medicines in development by product category.
Each of the above factors represents a driver for growth in vaccine development, which perhaps explains why there are more vaccine products (prophylactic and therapeutic) in development than any other class of biological medicine (see Figure 1)(3). This growth will only be sustained through innovation and strategic development, and although the biopharmaceutical industry has come a long way since the earliest days of vaccine manufacturing, the challenges remain fairly constant: What is the most reliable and cost effective manufacturing method? How does one ensure that the starting materials and final product are, respectively, consistently safe and of high quality? Who can manufacture the amount of vaccine needed for clinical trials and, eventually, commercial production?

In terms of both biochemical composition and methods of production, vaccines represent the most diverse class of biopharmaceuticals. Unlike monoclonal antibodies (mAbs) that are now produced and analyzed using relatively generic platform processes and methods, the complexity and variety of vaccines generate many challenges during process design and development. In this paper, the authors review the technological advances that will expedite vaccine development as well as add value to it. They also outline points to consider when choosing a contract manufacturing organization (CMO) for vaccine development projects.

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