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Tamiflu – Difficult or Easy to Make?

 

An argument that Tamiflu manufacturer Roche Holding has been using, to ward off attempts by rivals to launch their own production of the drug, is that it is extremely difficult to manufacture. As the Wall Street Journal reported:

 

In early October, with world-wide concern about bird flu spreading, the Swiss pharmaceutical company was under mounting pressure to allow other manufacturers to produce the antiviral drug as well. Roche resisted, saying Tamiflu…was too difficult for other companies to manufacture. Roche even pointed to a potentially "explosive" chemical step in the production process and said repeatedly that it would take several years for anyone else to make Tamiflu.

 

But a growing number of countries and companies are claiming they could quickly produce quantities of the drug, if allowed by Roche. The National Health Research Institutes of Taiwan says it has already produced small quantities. The Indian pharmaceuticals company Cipla says the same.

 

Against this is the argument that Tamiflu might be relatively easy to concoct in a laboratory, but producing commercial quantities is far more complex. In any case, Tamiflu is made from shikimic acid, which mainly is derived from the star anise spice, and star anise is in short supply.

 

However, the Shanghai Institute of Organic Chemistry says it has developed a different raw material, though will not give further details. And Professor John W. Frost, a chemist at Michigan State University, has also developed a technique for making shikimic acid without star anise.

 

And this week Roche revealed that it too is using synthetic shikimic acid for about a third of its Tamiflu production. It told journalists, during a tour of several of its plants, that a Japanese subsidiary had developed a fermentation process which was now used at a German plant operated by a Dutch company, DSM Nutritional Products.

 

According to an excellent report in the San Francisco Chronicle:

 

Three weeks ago, the Dutch operators of this vitamin plant switched the acid-making bugs to the big tank. It boosted production fivefold. "I am absolutely convinced that the productivity from fermentation will be more competitive than processing star anise," said John Buckingham, biotech plant manager for DSM Nutritional Products.

 

The watery acid produced at the 75-acre plant is shipped by tank truck to other subcontractors who perform somewhat risky chemical tricks -- involving toxic and potentially explosive processes -- that turn the acid into a milky substance ready for final mixing into the active drug.

 

Back at Roche headquarters in Basel, in a three-story building overlooking a children's playground and the Rhine River, the final blending steps take place. It is a warren of gray pipes, valves and round pressure gauges, like the insides of an old submarine, but smelling like a high school chemistry lab. The plant hums with powerful electric blenders stirring enclosed vats of Tamiflu, which through a glass porthole looks like vanilla yogurt.

 

Spun, filtered and dried in a vacuum, Tamiflu assumes a lightweight and wispy texture like cotton candy. Tanks of it are rolled across the street, to a clean-room where the drug is processed with alcohol into a dense white powder and slipped into yellow-and-white capsules, 10,000 per hour.

 

In 30-pound steel buckets, the capsules are sent to Kaiseraugst, a sprawling Roche factory about 10 miles outside Basel. Robot arms lift the buckets into machines that slip 10 pills -- a course of treatment -- into white cardboard boxes. Plant operator Marcus Zeh said his two Tamiflu lines stamp out "hundreds of thousands" of boxes per day -- enough at current rates to treat at least 60 million people.

 

Tamiflu – difficult or easy to make? It sure doesn’t sound easy.

   

Martin Roth
November 12th, 2005