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Simple new method detects contaminants in life-saving drug
November 18, 2008ANN ARBOR, Mich.---The blood-thinning drug heparin is highly effective when used to prevent and treat blood clots in veins, arteries and lungs, but earlier this year its reputation as a lifesaver was sullied when contaminated heparin products caused serious allergic reactions that led to a large number of deaths.
Now, University of Michigan researchers have demonstrated a simple, inexpensive method for detecting contaminants in heparin, a development that could prevent such tragedies in the future.
The new method is described in a paper published online Nov. 14 in the journal Analytical Chemistry.
The method relies on potentiometric polyanion sensors originally developed in the lab of U-M researcher Mark Meyerhoff as a tool for detecting heparin in blood. In the latest work, Meyerhoff and coworkers show that the disposable sensors also can be used to distinguish pure heparin from heparin that is tainted with small quantities of oversulfated chondroitin sulfate (OSCS), the culprit in the recent deaths.
"In this technique, the magnitude of the voltage you get from the sensing membrane is dependent on polyion charge density," Meyerhoff said, "and because the contaminant has a higher charge density than heparin, the method allows us to detect the contaminant in the presence of excess heparin."
The new method is simpler and less expensive than analytical methods such as nuclear magnetic resonance (NMR) and capillary electrophoresis (CE), which have been suggested for detection of OSCS contaminants.
Meyerhoff, who is the Philip J. Elving Professor of Chemistry, envisions the procedure being used on site in drug manufacturing plants to screen raw materials or finalized, biomedical grade heparin products for contaminants.
University of Michigan
The method relies on potentiometric polyanion sensors originally developed in the lab of U-M researcher Mark Meyerhoff as a tool for detecting heparin in blood. In the latest work, Meyerhoff and coworkers show that the disposable sensors also can be used to distinguish pure heparin from heparin that is tainted with small quantities of oversulfated chondroitin sulfate (OSCS), the culprit in the recent deaths.
"In this technique, the magnitude of the voltage you get from the sensing membrane is dependent on polyion charge density," Meyerhoff said, "and because the contaminant has a higher charge density than heparin, the method allows us to detect the contaminant in the presence of excess heparin."
The new method is simpler and less expensive than analytical methods such as nuclear magnetic resonance (NMR) and capillary electrophoresis (CE), which have been suggested for detection of OSCS contaminants.
Meyerhoff, who is the Philip J. Elving Professor of Chemistry, envisions the procedure being used on site in drug manufacturing plants to screen raw materials or finalized, biomedical grade heparin products for contaminants.
University of Michigan
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ASGE issues guidelines on management of antithrombotic agents for endoscopic procedures
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Scientists successfully reprogram blood cells
Researchers have transplanted genetically modified hematopoietic stem cells into mice so that their developing red blood cells produce a critical lysosomal enzyme -preventing or reducing organ and central nervous system damage from the often-fatal genetic disorder Hurler's syndrome.
Investigation of contaminated heparin syringes highlights medication safety issues
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Drug-eluting stents better than bare-metal stents for heart attack patients
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Otamixaban for the treatment of patients with non-ST-elevation acute coronary syndromes
Data from a phase II trial of an investigational intravenous drug designed to block the formation of blood clots shows potential to reduce the risk of death, a second heart attack, or other coronary complications compared with the current standard of care in patients presenting with acute coronary syndromes (heart attacks or unstable angina).
Patient safety advanced by revised heparin standards
Continuing to help ensure the identity, purity and quality of heparin, the U.S. Pharmacopeial (USP) Convention has revised written and physical standards for the widely used blood thinner.
'Artificial Golgi' may provide new insight into key cell structure
Scientists in New York and North Carolina are reporting assembly of the first functioning prototype of an artificial Golgi organelle.
Research highlights new approaches to prevent blood clots
Blood clotting, or coagulation, is an important process that prevents excessive bleeding when a blood vessel is injured.
HORIZONS AMI will help set guidelines for drug and stent therapy
The HORIZONS AMI clinical trial measuring the safety and efficacy of the use of the medication bivalirudin compared to standard drug therapy - heparin and glycoprotein IIb/IIIa inhibitors -- in heart attack patients who receive angioplasty, found that after 1 year, use of bivalirudin resulted in significantly lower rates of all-cause death, death from cardiac causes, and major bleeding.
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