6437 BioGX

Heparin Contamination

Pharma QC

This novel real-time PCR-based reagent detects ruminant (bovine, caprine, and ovine) and porcine origin DNA.The US FDA recently released a protocol utilizing this reagent to identify ruminant DNA in pig-derived crude heparin. It has been independently evaluated using very strict performance criteria and was recenty converted to BioGX’s easy to use Sample-Ready™ format. Note: this reagent is has only been validated on the Cepheid SmartCycler II. Please Note: Due to the innovative nature of our products, new reagents are frequently being brought online. Please check our site regularly for the latest updates. BioGX Ruminant and Porcine DNA Panel

Ruminant DNA, Porcine DNA, IAC. Product #204-0002 4-plex panel (3 channels) Packaging: 48 Sample-Ready™ reagents [4 reactions per tube, 12 tubes per pouch]

 Ruminant and Porcine DNA Panel Development Information

CLICK HERE to access the complete FDA protocol Background

FDA considers the presence of any non-porcine origin material (especially ruminant material) in heparin to render that drug adulterated. According to FDA, “the control of the animal origin of crude heparin is important to ensure the safety of drugs and devices that contain heparin and to protect public health.

Publication Reference

Development of a Multiplex Real-Time PCR Assay for the Detection of Ruminant DNA in Raw Materials used for Monitoring Crude Heparin for Quality

Authors: Sharla M. Peters1, Yolanda L. Jones1, Frank Perrella2, Tai Ha3, and Haile F. Yancy1

Affiliations: 1U. S. Food and Drug Administration, Center for Veterinary Medicine, Office of Research, 8401 Muirkirk Road, Laurel, Maryland 20708, USA. 2U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Compliance, Silver Spring, MD 20993, USA. 3Nebraska Department of Agriculture, 301 Centennial Mall South, Lincoln, Nebraska 68508, USA.

Abstract: A real-time PCR assay was developed for the determination of ruminant material in porcine-derived crude heparin products. The assay consists of a bead format with lyophilized primers and probe sets that identify ruminant (bovine, ovine, caprine) and porcine material and also contain an internal amplification control. The assay was verified by two analysts: the first located at the FDA and the second at an independent State laboratory. Performance of the assay was evaluated against stringent acceptance criteria developed by the U.S. FDA’s Center for Veterinary Medicine’s Office of Research. The heparin Multiplex Real-Time Assay (hMRTA) for the detection of ruminant DNA in porcine crude heparin passed the stringent acceptance criteria for specificity, sensitivity, and selectivity. The assay met sensitivity and reproducibility requirements previously established by the multiplex real-time PCR assay (MRTA) for detection of ruminant animal material in feed. The hMRTA, when used in porcine crude heparin, exhibited 98% sensitivity, 98% true positives, 2% false negatives. This multiplex PCR-based assay detects three ruminant species, verifies porcine origin and could be used as a screening tool or as a confirmatory assay. It is capable of providing additional assurances of crude heparin quality and will help to identify and control the species origin of the heparin supply. The control of the animal origin of crude heparin is important to ensure the safety of drugs and devices that contain heparin and to protect public health.

Please also refer to FDA’s Draft Guidance for Industry, titled: Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality. CLICK HERE for link to document.