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Heparin plot thickens, contaminant found
The full story of the heparin problems is beginning to emerge. The Chicago tribune reports that a still unidentified foreign substance has been found in the drug that is similar chemically to the real active ingredient. Now the question is, where did it come from? The U.S. FDA thinks that it could have been added deliberately or it may be a byproduct of the biological process.
While trying not to think the worst, situations where sawdust has been mixed into the pharmaceutical bread have happened before in China. The article cites a particular case with an antibiotic, gentamicin sulphate, where producers added other substances to fill out batches. The results included fatalities in the U.S.
Another possibility is that the product was harvested from sick pigs. Heparin comes from an enzyme in pig intestines (Ewww...those should only be used as sausage casings.) and the contaminated lots were made after an outbreak of "blue ear" that affected 250,000 pigs. Evidently those pigs should not have made it into the supply stream. This possibility is still under investigation but hasn't been pinpointed.
One interesting point has emerged from the story that shouldn't be news to anyone in the pharmaceutical industry. The normal testing protocols used for heparin did not discover the foreign substance due to its chemical similarity to the real ingredient. The testing done to the product in normal manufacturing only looks for specific quality attributes. It is not a broad spectrum process that considers every possibility.
The one glimmer of hope that has emerged from the incident is that the U.S. FDA plans to increase its overseas plant inspections and improve relations with foreign regulators. Be thankful for small favors.
Heparin plot thickens, contaminant found
March 7, 2008
The full story of the heparin problems is beginning to emerge. The Chicago tribune reports that a still unidentified foreign substance has been found in the drug that is similar chemically to the real active ingredient. Now the question is, where did it come from? The U.S. FDA thinks that it could have been added deliberately or it may be a byproduct of the biological process.While trying not to think the worst, situations where sawdust has been mixed into the pharmaceutical bread have happened before in China. The article cites a particular case with an antibiotic, gentamicin sulphate, where producers added other substances to fill out batches. The results included fatalities in the U.S.
Another possibility is that the product was harvested from sick pigs. Heparin comes from an enzyme in pig intestines (Ewww...those should only be used as sausage casings.) and the contaminated lots were made after an outbreak of "blue ear" that affected 250,000 pigs. Evidently those pigs should not have made it into the supply stream. This possibility is still under investigation but hasn't been pinpointed.
One interesting point has emerged from the story that shouldn't be news to anyone in the pharmaceutical industry. The normal testing protocols used for heparin did not discover the foreign substance due to its chemical similarity to the real ingredient. The testing done to the product in normal manufacturing only looks for specific quality attributes. It is not a broad spectrum process that considers every possibility.
The one glimmer of hope that has emerged from the incident is that the U.S. FDA plans to increase its overseas plant inspections and improve relations with foreign regulators. Be thankful for small favors.
Posted by Peter Welander on March 7, 2008 | Comments (0)
Industries: Process Control
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