Friday, September 21, 2012

Pharma’s next danger: deindustrialization

You probably know that deindustrialization in the west cannot allow US to launch new moon flight and basically NASA has to stop the majority of projects. Do you know what? Terrible news! The next will be Pharma. Already now we can see a dangerous sign for inability to manufacture medicinal products!
Danish drugmaker Lundbeck has told doctors in a letter that beginning in December, it will stop supplying its leukemia drug Elspar because it has been unable to get a steady supply of the API.
 In an email to FiercePharma, Matt Flesch, Lundbeck senior manager of communications, explained the drug is a very old biological product and difficult to manufacture. The company has used a contractor to make Elspar. Flesch said that when Lundbeck acquired the product in 2006, the company had to update underlying process technology and analytical methods to meet new guidelines for biologics. Still, he said, "Authorities in some markets outside the U.S. have been reluctant to accept many of these improvements, due to evolving and often tighter controls linked to biologics." Even with all of the investments, the company has had difficulty getting a guaranteed supply of the API, and to do that would require additional process and specification changes that might not be approved by regulators.
And do not blame the authorities – there is always a possibility to solve any problem if there is a desire and industrial and scientific competence. Otherwise? Welcome to post-industrial deindustrialized world!

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