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10/10/2000 - Cincinnati, Ohio -- Celsus Laboratories, Inc., a Cincinnati based manufacturer of heparin and other complex carbohydrates from animal tissue, has completed validation of its manufacturing process to clear the etiological agent responsible for transmissible spongiform encephalopathies (TSE). The best known TSE are “scrapie” in sheep and "mad cow disease”. The latter has been linked with a new variant of the inevitably fatal human brain disorder known as Creutzfeldt-Jakob Disease. TSE’s are associated with the transmissibility of a protease-resistant variant of the prion protein found in brain.

Celsus, more than one year ago, commenced the screening of its raw materials for the presence of prion antigens using an immunoassay developed at Celsus. The assay is sensitive to the presence of about 10,000 TSE infectious units, but not lower. The raw material testing, although not required by regulatory authorities, was nonetheless initiated by Celsus amid growing scientific concern over the potential presence of TSE in the food chain.

As one single infectious unit is theoretically sufficient to cause disease, Celsus simultaneously sponsored a study of its ability to remove about 1,000,000 TSE infectious units from a crude "stage 12" heparin sample spiked with scrapie. The sponsored study performed by a leading US academic institution for TSE research used a quantal-based detection system in hamsters sensitive to the presence of a single infectious unit. The result of the 250 days trial showed that all animals injected with the Celsus-purified heparin remained healthy and free of any detectable TSE-associated prion antigens. In contrast, animals, even those receiving only a single infectious unit of a non-purified sample developed the full-blown brain malady.

The validation of the Celsus process has heightened relevance given the findings of researchers at the Prion Unit of the Medicines Research Counsel of London that TSE may transmit more easily than was previously thought from one specie to another which may result in an occult sub-clinical form that may manifest at some time later. More recently, researchers at the Animal Health Institute in Edinburgh found that TSE may be transmitted through blood transfusion among species showing no symptoms of the disease.

For nearly 75 years, heparin has remained the anticoagulant of choice in the prevention and treatment of thrombo-embolic disorders, end-stage renal dialysis and cardiopulmonary bypass surgery; collection, fractionation, and analysis of blood; and non-thrombogenic coatings for coronary stents and other blood-interacting medical devices. Heparin also serves as an affinity ligand in the purification of many bio-engineered heparin-binding proteins, and as "the" raw material for low molecular weight heparins used clinically.

The validation study will become a part of Celsus' drug master files on its heparin-related products when filed with the FDA, the Medicines Control Agency of England, the Therapeutic Goods Administration of Australia and other regulatory agencies abroad.