Vivalis files BMF for EB66 cell line

By Nick Taylor

- Last updated on GMT

Related tags Cell line Biotechnology

Vivalis has filed the biologics master file (BMF) with the US Food
and Drug Administration for its EB66 vaccine and therapeutic
protein production technology.

Successful navigation of the regulatory step will enable companies that have licensed the EB66 cell line to file requests for clinical trials of products produced using the technology. Following authorisation from the FDA Vivalis expects approval for clinical trials to be requested by its commercial partners in 2009 or early 2010. Speaking to in-PharmaTechnologist.com, Franck Grimaud, Vivalis CEO, explained the advantages EB66 offers over egg based production and other cell lines. With regards to egg based production he said: "If you wanted to qualify a new egg based vaccine it would not be possible with new regulatory standards. It is a rough and simple system​." In addition scaling up production in cell lines is easier and the system can produce a new vaccine in a shorter space of time. Grimaud also went on to explain that EB66 offers advantages over other cell lines, primarily that it can produce almost all viruses currently manufactured in eggs whereas others only have the capability to make a small proportion. The EB66 cell line was spawned from Vivalis' EBx technology which involved research into the use of duck embryonic stem cells for the production of vaccines and therapeutic proteins. In EB66 Vivalis has created an immortal cell line, meaning one that will replicate indefinitely. This was acheived without genetically, chemically or virally modifying the cells, creating a production system without the inherent genetic instability or tumorigenicity associated with existing cell lines. These properties have generated a great deal of interest in the EB66 cell line technology, with Vivalis claiming 75 per cent of the major players in the vaccine market are currently using or testing the production technique. This includes such powerhouses as Sanofi Pasteur, GlaxoSmithKline and Novartis. In addition to this sector companies involved in the production of monoclonal antibodies have also been taking an interest in the technology. Vivalis commercial partners will be awaiting the outcome of the BMF, which covers the process of establishing the EB66 cell line, a description of the raw materials and facilities used and a demonstration the cell line is free from viral or bacterial contaminants. Majid Mehtali, Vivalis' chief scientific officer, said: "This filing represents a decisive step in the establishment of the EBx platform as a benchmark cellular substrate for the industrial production of a very large number of vaccines, as well as monoclonal antibodies with increased cytotoxic activity​."

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