GSK and its partner Vivalis (France) received clearance from the FDA to begin testing an influenza vaccine in a Phse I trial in humans that will be produced in the Vivalis EB66 duck stem cell line. This is the first trial for the line as an alternative and better technology than chicken eggs for producing vaccines. The flu vaccine could be marketed as soon as 2015 if it progresses through its trials according to plan.
VIVALIS' EB66® platform, which was used to develop the EB66® cell line, uses a revolutionary technology to derive avian-based stem cells for vaccine production. EB66® cells are non-genetically modified and represent the closest cell-based substrate for chicken egg substitution. Unlike many other cell lines, the EB66® cell line does not require the use of viral genes to enable continuous and stable growth.
Vivalis issued a press release that further states:
"This achievement supports the regulatory review of the EB66® cell line by the US FDA and the corresponding Biologics Master File submitted to the agency in 2008. Evaluation or development programs for EB66® cells are being conducted by over 75% of the world's leading vaccine developers in human and animal health, with over 25 license and commercial agreements in place to date. Influenza is the largest and fastest growth sector in the vaccine field, having sales of $2.8 billion in seven major markets. This milestone is shared not only by VIVALIS but also our dedicated partners and shareholders. We continue in our commitment to advancing innovative technologies in markets where commercial success is defined by safety, efficacy, and efficiency," said Franck Grimaud, CEO, and Majid Mehtali, CSO, co-managers of VIVALIS.
SAFC collaborated with Vivalis on the creation of serum-free cell culture growth and viral production media to be used specifically with the EB66 cell line. See here for more information on EBx Media and Feeds on the SAFC website.
Posted by Bruce Lehr November 24th 2010.
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