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[SANET-MG] vaccine made in plant cells in vitro

Pharm crops are a problem unless the crop is grown in a bottle. That approach seems to work and possibly provides products free of prions and animal viruses.
 Financial Times FT.com

US regulators approve vaccine made in plant cells
>By Clive Cookson in London
>Published: February 1 2006 02:00 | Last updated: February 1 2006 02:00
The world's first vaccine made in plant cells has received regulatory approval in the US. The pioneering vaccine, developed by Dow Chemical with a consortium of US research institutions, works against Newcastle disease in poultry but the company says the technology could be applied quite quickly to other diseases - with avian flu a prime target.

There have been several research efforts around the world to produce vaccines in genetically modified plants, growing in fields or glasshouses, but these have run into trouble on reliability, safety and environmental grounds. Dow took a different approach, using cultures of GM plant cells contained in steel fermenters.

The company said its Concert plant cell approach removed "the challenges associated with making vaccines in whole plants or food crops", while retaining the advantages of a production system that can make large amounts of vaccine completely free of animal or bacterial contamination. All existing systems are based on animals, birds or microbes.

Butcher Mercer, head of Dow's animal health business, said the company applied for a product licence for the Newcastle disease vaccine, through the US Department of Agriculture's Centre for Veterinary Biologics, to prove that it could win regulatory approval for a plant-made vaccine. The process uses cells from tobacco plants, genetically altered to produce the parts of the disease-causing virus required to stimulate immunity.

"There are already several Newcastle disease vaccines on the market and another one is not going to set the world on fire," said Mr Mercer. "We used this vaccine to pave the regulatory pathway and show that we could meet the strict standards required. We have a full pipeline of products behind this one."

John Cuffe, head of research for animal health, said other plant-made products with greater commercial potential would reach the market by 2010. One is an avian flu vaccine, designed initially to prevent infection in birds, which could be extended to produce a human flu vaccine.

Dow began work on the project just five years ago, in collaboration with Washington University in St Louis, Boyce Thompson Institute for Plant Research, Benchmark Biolabs and Arizona State University's Biodesign Institute.

"Most of the research on plant vaccines had been done with 'open field' production systems but we felt that a cell culture system would be much more amenable for regulatory approval and would be much more reliable," said Mr Mercer. "An open field system can produce much larger volumes of material but we we only need microgrammes of protein for our vaccines."

*The European Commission will today demand that France be fined by the European Court of Justice for failing to transpose into law a directive designed to prevent the release of unauthorised genetically modified organisms into the environment, Karl de Meyer reports from Paris.

It is understood the College of Commissioners will launch the action after twice warning France last year for failing to draw up emergency plans in case of accidental release of modified organisms from laboratories.


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