Control Engineering

Peter Welander

The lessons of heparin
March 28, 2008

Over the last few days I have been at the INTERPHEX conference in Philadelphia. While there, I asked a number of people that I chatted with what they thought the lessons of heparin might be. I don't think anyone wanted to talk for the record. The whole thing makes everybody a little too nervous.

There was sort of a general consensus with several points:

• Anybody who wants to source in China will have to pay a whole lot closer attention to quality control. The U.S. FDA and Chinese equivalent are far from being able to help in any meaningful way.
• Don't assume a producer has the slightest idea of what GMP means. There simply is not enough experience base in China yet, but it is growing.
• This experience will give a boost to companies to produce in the U.S. or more established parts of the world, but it will probably be a small boost. Outsourcing to China still has its cost appeal, and that's hard to ignore.
• Regulation will improve, but don't expect anything overnight.
• Companies will likely put some additional effort into more synthetic products that don't involve dead animal parts as feedstock. At least as long as costs are reasonable.

If we have another episode like this while heparin is still fresh in our minds, it could change things dramatically in a very short time.

And, to answer the question that I am sure is foremost in your thinking, yes, I got to hear the Wanamaker pipe organ play for about 20 minutes. I certainly enjoyed it, but the concert was very short.

Posted by Peter Welander on March 28, 2008 | Comments (0)