Catridecacog API Manufacturers

General Description:

Catridecacog, identified by CAS number 606138-08-3, is a notable compound with significant therapeutic applications. Coagulation Factor XIII A-Subunit (Recombinant), also known as catridecacog, is a recombinant form of the Factor XIII-A2 homodimer composed of two factor XIII (FXIII) A-subunits . For people with congenital deficiency or mutation of Factor XIII, a rare bleeding disorder, exogenous replacement of this key coagulation factor is essential for management and prevention of bleeding episodes. Also known as Fibrin Stabilizing Factor (FSF), Factor XIII is an endogenously available coagulation factor and the final enzyme within the blood coagulation cascade. Within the body, FXIII circulates as a heterotetramer composed of 2 catalytic A-subunits and 2 non-catalytic B-subunits (FXIII-A2B2) . When activated by thrombin at the site of injury, the FXIII A2B2 pro-enzyme is cleaved resulting in activation of the catalytic A-subunit and dissociation from its carrier B-subunit. As a result, the active transglutaminase from subunit A cross-links fibrin and other proteins resulting in increased mechanical strength and resistance to fibrinolysis of the fibrin clot. This contributes to enhanced platelet and clot adhesion to injured tissue, thereby improving blood coagulation and maintenance of hemostasis . When supplied as the recombinant form, Coagulation Factor XIII A-Subunit (Recombinant) binds to free human FXIII B-subunit resulting in a heterotetramer (rA2B2) with a similar activity profile and half-life as the endogenously available form. In patients with congenital factor XIII A-subunit deficiency, this product (marketed as Tretten) is indicated for the routine prophylaxis of bleeding. In these patients, activated rFXIII has been shown to increase the mechanical strength of fibrin clots, slow down fibrinolysis, and to enhance platelet adhesion to the site of injury. As the half-life of endogenous Factor XIII is long (5-11 days), prophylactic therapy with the replacement of FXIII can be given every 4-6 to maintain hemostasis. Other drug products with similar structure and function to Coagulation Factor XIII A-Subunit (Recombinant) include , which is a purified endogenous (human) form of coagulation factor XIII. Compared to Coagulation Factor XIII A-Subunit (Recombinant), which is produced through recombinant DNA technology where the target protein is grown in yeast and then isolated, the human form is isolated from pooled human plasma. Coagulation Factor XIII A-Subunit (Recombinant) is available in the US as the commmercially available product Tretten, and in the EU as NovoThirteen. Tretten is manufactured as an intracellular, soluble protein in yeast (Saccharomyces cerevisiae) production strain containing the episomal expression vector, pD16. It is subsequently isolated by homogenization of cells and purification by several chromatography steps, including hydrophobic interaction and ion exchange chromatography .

Indications:

This drug is primarily indicated for: For routine prophylaxis of bleeding in patients with congenital factor XIII A-Subunit deficiency. Its use in specific medical scenarios underscores its importance in the therapeutic landscape.

Absorption:

The absorption characteristics of Catridecacog are crucial for its therapeutic efficacy: Following intravenous administration, the maximum concentration (Cmax) was found to be 0.48 IU/mL . The drug's ability to rapidly penetrate into cells ensures quick onset of action.

Half-life:

The half-life of Catridecacog is an important consideration for its dosing schedule: 7.1 days. This determines the duration of action and helps in formulating effective dosing regimens.

Clearance:

The clearance rate of Catridecacog is a critical factor in determining its safe and effective dosage: 0.41 mL/h/kg. It reflects the efficiency with which the drug is removed from the systemic circulation.

Toxicity:

Classification:

Catridecacog belongs to the None, classified under the direct parent group Peptides. This compound is a part of the Organic Compounds, falling under the Organic Acids superclass, and categorized within the Carboxylic Acids and Derivatives class, specifically within the Amino Acids, Peptides, and Analogues subclass.

Categories:

Catridecacog is categorized under the following therapeutic classes: Blood and Blood Forming Organs, Blood Coagulation Factors, Hemostatics. These classifications highlight the drug's diverse therapeutic applications and its importance in treating various conditions.