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Method of Detecting and Quantifying Contaminants in Heparin Preparations

Posted May 04 2009 5:00pm

Description of Invention:
Heparin is a naturally occurring acidic carbohydrate produced commercially from extracts of animal tissues (such as bovine lung or porcine intestine) and is used in the treatment of a wide range of diseases in addition to their classic anticoagulant activity. Heparin is also used to coat many medical devices, such as catheters, syringes, stents and filters. Recently, certain lots of heparin were associated with serious side effects and adverse events. Recalls were issued in multiple countries and it became evident that there was an extensive problem with heparin manufacture.

Traditional tests may not be able to determine the presence of contaminant(s) without lyophilizing and concentrating each sample and may not be suitable for testing finished medical devices. Therefore, there is a demonstrated need to develop other assay methods for detecting contaminating oversulfated compounds of any source in heparin and heparin derived products.

This technology relates to methods for detecting and/or quantifying oversulfated glycosaminoglycans based on inhibition of nucleic acid polymerases and resistance to enzymatic degradation. It also relates to the use of these methods to screen and quantify pharmaceutical preparations such as heparin preparations for oversulfated contaminants.

Robust, simple and effective method for detecting and optionally quantifying oversulfated contaminants in heparin preparations.

Development Status:
The method has been developed and qualified for sensitivity and identity, but full validation and commercialization have not been undertaken.

Daniela Verthelyi (FDA)

Patent Status:
HHS, Reference No. E-227-2008/0
PCT, Application No. PCT/US2009/056263 filed 08 Sep 2009

Relevant Publication:
  1. C Tami, M Puig, JC Reepmeyer, H Ye, DA D’Avignon, L Buhse, D Verthelyi. Inhibition of Taq polymerase as a method for screening heparin for oversulfated contaminants. Biomaterials 2008 Dec;29(36):4808-4814. [ PubMed abs ]

Licensing Status:
Available for licensing.

Collaborative Research Opportunity:
The FDA, Division of Therapeutic Proteins, Laboratory of Immunology, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this high throughput screening test for oversulfated glycosamineglycan contaminants in heparin. Please contact Daniela Verthelyi at or Alice Welch at for more information.

Internal Medicine
Internal Medicine - Diagnostics

For Additional Information Please Contact:
Fatima Sayyid MHPM
NIH Office of Technology Transfer
6011 Executive Blvd. Suite 325 Room 21,
Rockville, MD 20852
United States
Phone: 301-435-4521
Fax: 301-402-0220

Ref No: 1938

Updated: 05/2009

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