Platform for vaccines
Established continuous, embryonated chicken eggs and primary chicken embryo fibroblasts (CEF) have been used for decades for the manufacturing of human and veterinary vaccines. However, such substrates are limited by various drawbacks such as risks of bacterial contaminations (regular chicken embryos), need of large quantities of specific-pathogen free materials (SPF chicken embryos), limited life span (primary cells), genetic instability (continuous cell lines), low cell densities or poor productivities. Valneva's EB66® cell line is a unique and revolutionary alternative for the cost-effective manufacturing of vaccines currently produced in eggs or in CEFs.
EB66®, maintains most of the desirable features of ES cells (ie. strong expression of telomerase and stem cells markers, indefinite cell proliferation, long-term genetic stability, etc.) but displays new industrial- and regulatory-friendly characteristics (ie. proliferation in stainless-steel and single use bioreactors at high cell densities as suspension cells up to a 1000L scale, growth in chemically defined media, high susceptibility to various human and animal viruses, efficient production yields of a wide range of human and animal vaccines). Fully controlled GMP EB66® cell banks have been generated and a biologic master file describing the history, traceability of raw materials and results from extensive quality controls was filed in 2008 with the US FDA. It is licensed to the majority of players in the human and veterinary vaccine industry.