Another important driver of the cell culture market will be the production of seasonal influenza vaccines, as well as pandemic vaccine candidates. The next generation of seasonal influenza and pandemic vaccines will be produced by cell culture-based technology. This trend bodes well for the continued growth of the cell culture market.
The traditional method of manufacturing influenza vaccines has been through egg-based technology. However, due to the sheer quantity of vaccines that may be needed in the future, both for seasonal influenza and pandemic influenza, there is a move away from egg-based systems. Cell-based vaccine production dramatically reduces the possibility for contamination and promises to be a more reliable, flexible, and expandable platform than egg-based methods.
While both methods could produce an equally effective vaccine against a virus, egg-based production is physically limited by the availability of specialized eggs and alone may not be able to meet the accelerated demands of a global influenza pandemic. Cell-based technology offers many benefits over egg-based production, including scalability, production risk mitigation (In the case of an avian flu pandemic, egg-producing flocks could decline, jeopardizing vaccine production capabilities.), speed of development (manufacturers are able to bypass the steps needed to adapt the virus strains to grow in eggs), and hypoallergenicity.
The U.S. government has been encouraging manufacturers to develop cell-based flu vaccine methods in recent years. The National Institute of Allergy and Infectious Diseases (NIAID) supports a research program to advance the development of cell culture technologies to improve and modernize the production of influenza vaccines. Between fiscal years 1998 and 2005, NIAID’s support for research for cell culture technology totaled approximately $35 million, according to the Department of Health and Human Services (HHS).
In addition, in March 2005 the HHS awarded a five-year contract to Sanofi Pasteur for $97 million to develop cell-based influenza vaccine technology, with the goal of obtaining the FDA license for a vaccine. In September 2006, Sanofi Pasteur announced that it had completed a clinical trial of its cell culture-based seasonal influenza vaccine and demonstrated the production-scale potential of a cell line in a successful bioreactor run of 20,000 L.
In October 2005, Chiron initiated a Phase I/II study of an investigational cell culture–derived influenza vaccine in the U.S. The company has also completed enrollment of a second Phase III study of a influenza cell culture vaccine in Europe. In July 2006, Novartis reported that it plans to build a new plant to make cell-culture-based influenza vaccines. The plant could begin production as early as 2011 and be ready for full production as early as 2012.