Under the agreement, Synthetics Genomics Vaccines (SVGI) will sequence genes representing various viruses, including influenza, and apply its synthetic genomics technology to produce seed strains for vaccine manufacturing. Novartis, meanwhile, will use SVGI’s findings to develop disease-preventing vaccines.
The three-year deal between the companies is supported by the US Biomedical Advanced Research and Development Authority, the government agency responsible for overseeing vaccine and drug development for public-health emergencies.
Eric Althoff, a Novartis spokesperson, told Outsourcing-Pharma, “At Novartis we have an ongoing commitment to pandemic preparedness,” adding SGVI’s synthetic technology “could speed vaccine production by 1-2 months, saving crucial time, especially in the case of a pandemic.
“As the onset of a pandemic may evolve rapidly, it is important to invest in new technologies that will enable the production of as many safe and effective vaccine doses as soon as possible,” commented Althoff. “With the introduction of this new technology we hope to continue pre-pandemic preparedness efforts to benefit public health,” he added.
Unlike most existing methods, synthetic vaccinology can be used to design and construct vaccines based on computer transmitted data, without using materials from infected patients. This speeds up the manufacturing process by eliminating the need to source virus strains and genes from clinical samples.
‘Bank’ of synthetic flu virus strains
The companies say that part of their plan is to develop a library of synthetic flu virus strains, ready to go to production as soon as the World Health Organisation (WHO) identifies the strains. This will provide “intitial immunization with a sufficiently matched vaccine during the first pandemic wave, while an optimally matched vaccine seed is being synthesized,” said Althoff.
Novartis ramped up cell-based vaccine capacity in 2009 by starting work on a new manufacturing facility in Holly Springs, North Carolina, US, in November 2009. Once completed, the site will have the capacity to provide 150m doses of influenza vaccine within six months of a flu pandemic being announced.
According to Althoff, the facility will be ready to respond to such a pandemic as early as 2011 if licensed in an emergency, while the site should be running at full scale and approved for commercial production by 2013.