The company has signed a deal to license platform technology from North Carolina State University which details a method of producing undifferentiated avian cell cultures using avian primordial germ (PGC) cells. The new technology will add to the already popular EBx avian embryonic stem cell lines which are currently being used by Sanofi Pasteur, GlaxoSmithKline and Novartis for vaccine and therapeutic protein development.
"[We have signed this agreement] in order to be the sole company in the world to have all patents in avian stem cells. We want to build a very strong position [in this area]," Vivalis chief executive Franck Grimaud told in-PharmaTechnologist.com. "This is mainly to create new cell lines - that's what we are focussing on - for production of vaccines or proteins."
This new license related to culture processes and culture media for avian stem cells and supplements two licenses already signed with North Carolina State University in 2002. According to the United States Patent and Trademark Office the technology platform is described as: "A method of producing undifferentiated avian cells expressing an embryonic stem cell phenotype. The method includes the steps of collecting avian gonadal cells comprising primordial germ cells from an avian embryo after the formation of the primitive streak; depositing the avian gonadal cells in contact with a preconditioned feeder matrix; and growing the avian gonadal cells on the pre-conditioned feeder matrix in the presence of media for a time sufficient to produce an avian cell culture consisting essentially of undifferentiated avian cells expressing an embryonic stem cell phenotype."
Vivalis would develop its own cell lines using the technology and then license it out to partners. The license grants Vivalis exclusive rights to apply the methodology worldwide. The terms of the agreement were undisclosed.
Cell-based vaccine production offers an alternative to traditional egg-based vaccine production, being seen as safer and more efficient. Embryonated chicken eggs and chicken embryo fibroblasts (CEF) have been the traditional tools for vaccine production, but manufacturers are becoming increasingly disenchanted with the method, which involves a lengthy manufacturing process requiring numerous eggs, the risk of infection in donor flocks, bacterial contaminants, or the inability to manufacture particularly virulent viruses.
All human flu vaccines currently available on the market are produced using this egg-based technique, though the potential value cell-based vaccine manufacture could have has been widely acknowledged within the industry. Grimaud said the technology was not only attractive for influenza vaccine manufacturing, but that more than 25 viruses could be transferred to the cell lines for vaccine production.
Last month the company announced the first data evaluating EBx cell lines for the production of monoclonal antibodies.
The antibodies produced using the EBx cell lines showed remarkably low fucose content - a key point in favour of the production method as reduced fucose content is known to be associated with improved antibody-dependent cell cytotoxicity (ADCC) activity, particularly important in treating cancerous cells.