Recombinant Urokinase (rUK)

Recombinant urokinase is a drug substance with a similar structure and function as Urokinase extracted from human urine.

Synonyms

• Recombinant human two-chain high molecular weight urokinase
• Recombinant human urinary type plasminogen activator
• HMW tc-uPA
• HMW-UK

Background and use

Extractive Urokinase is an enzyme used in human medicine for clot lysis in various indications (such as peripheral arterial occlusion, deep venous thrombosis, stroke, catheter clearance, myocardial infarction). Its biological function consists in the activation of plasminogen to plasmin, allowing for restoration of patency of blood vessels obstructed by thrombus formation or fibrin sleeves.

Recombinant urokinase developed by Cerbios is a drug substance with a similar structure and function as Urokinase extracted from human urine, which has been used in pharmaceutical products in Europe for the last thirty years. Cerbios’ rUK is obtained by state of the art rDNA technology from a CHO cell line and is therefore glycosilated.

Cerbios is ready to prepare cGMP material for clinical trials, to be carried out according to a potential partner’s clinical development strategy.

Regulatory compliance

The manufacturing technology makes use of chemically defined, serum-free, protein-free media; no growth factors or antibiotics are added. All the components of media and solutions are certified to be of non-animal origin. The technology has already been presented to FDA in a pre-IND meeting.

Intellectual property

The manufacturing system is based on a proprietary process.

For more information please see our website, or contact us.