Moroctocog alfa (BDDrFVIII)

Specification

• Cat#: THP-0085
• Product Name: Moroctocog alfa (BDDrFVIII)
• Description: The product, also known as B domain deleted recombinant factor VIII, is a recombinant DNA-based product with functional characteristics comparable to those of endogenous coagulation Factor VIII, the essential human blood clotting protein that is impaired in Hemophilia A. The product is identical in sequence to endogenously produced Factor VIII, but does not contain the B-domain, which has no known biological function. The product is produced through recombinant DNA technology and purification, resulting in a 1438 amino acid, 170 kDa protein. Clinical evaluation has shown that BDDrFVIII is pharmacokinetically equivalent to full-length recombinant FVIII.
• Sequences: Not Available
• Species: Human
• Molecular Weight: 173000.0 Da (glycosylated)
• Purity: >99% by SDS-Page and HPLC analysis
• Cas No: 284036-24-4
• Formula: Not Available
• Endotoxin Level: <0.001 EU per 1 μg by the LAL method
• Biological Activity: 250U-3000U/vial

Pharmaceutical Information

• Pharmaceutical Application: Moroctocog alfa
• Applications: The product is approved by Health Canada for the control and prevention of hemorrhagic episodes and for routine and surgical prophylaxis in patients with hemophilia A (congenital factor VIII deficiency or classic hemophilia). The product is also approved by the European Medicines Agency for the treatment and prophylaxis of bleeding in patients with Haemophilia A (congenital factor VIII deficiency).
• Examples of Clinical Use: Bleeding in Haemophilia A (congenital factor VIII deficiency).
• Pharmacodynamics: Antihemophilic Factor binds factor IXa along with calcium and phospholipid, which converts factor X to factor Xa to facilitate the clotting cascade.
• Mechanism of action: Antihemophilic factor (AHF) is a protein found in normal plasma which is necessary for clot formation. The administration of AHF provides an increase in plasma levels of AHF and can temporarily correct the coagulation defect of patients with hemophilia A (classical hemophilia). As factor VIII is the specific clotting factor deficient in patients with hemophilia A, replacement of clotting factor with Moroctocog alfa, also known as BDDrFVIII (B domain deleted recombinant factor VIII), is the cornerstone of the prevention and treatment of bleeding for this disorder.
• Affected organisms: Not Available
• Targets: Target 1. Coagulation factor X; Target 2. Phytanoyl-CoA dioxygenase, peroxisomal; Target 3. Coagulation factor IX; Target 4. Asialoglycoprotein receptor 2; Target 5. 78 kDa glucose-regulated protein; Target 6. Calreticulin; Target 7. Calnexin; Target 8. Protein ERGIC-53; Target 9. Prolow-density lipoprotein receptor-related protein 1; Target 10. Multiple coagulation factor deficiency protein 2; Target 11. von Willebrand factor; Enzyme 1. Prothrombin; Enzyme 2. Vitamin K-dependent protein C

Related Reading

The origin of Moroctocog alfa (BDDrFVIII)

Moroctocog alfa, also known as BDDrFVIII, is a recombinant factor VIII (rFVIII) product used for the treatment of hemophilia A, a genetic bleeding disorder caused by deficient or defective factor VIII. Moroctocog alfa is produced using recombinant DNA technology, where the gene for factor VIII is inserted into a host cell (usually a mammalian cell) for production. The "BDD" in BDDrFVIII stands for "B-domain deleted," indicating that a portion of the B-domain of the factor VIII molecule has been removed during the manufacturing process. This modification is intended to improve the stability and pharmacokinetics of the factor VIII molecule.
The development and manufacturing of Moroctocog alfa involve a complex process that includes cell line development, fermentation, purification, and formulation. The product undergoes rigorous testing to ensure safety, efficacy, and consistency before being approved for clinical use. Moroctocog alfa has been developed by various pharmaceutical companies and has undergone extensive clinical trials to demonstrate its safety and effectiveness in managing bleeding episodes and preventing bleeding in people with hemophilia A. It is an important treatment option for individuals with this condition, providing them with the necessary factor VIII to support blood clotting and prevent excessive bleeding.

Composition and structure of Moroctocog alfa (BDDrFVIII)

The specific composition of Moroctocog alfa (BDDrFVIII) may vary depending on the manufacturer and formulation, but typically it includes the following components:
1. Recombinant factor VIII: This is the active ingredient responsible for replacing the missing or deficient factor VIII in patients with hemophilia A.
2. Stabilizers: These are additives used to protect the protein and maintain its stability during storage and handling. Common stabilizers include human serum albumin, sucrose, and other inert substances.
3. Buffering agents: These are used to maintain the pH of the solution within a specific range to ensure the stability and activity of the factor VIII protein.
4. Antioxidants: These are added to prevent oxidation of the protein, which could lead to degradation and loss of activity.
5. Preservatives: In some formulations, preservatives may be added to prevent microbial contamination during storage.
Moroctocog alfa (BDDrFVIII) is a recombinant human coagulation factor VIII (FVIII) used to treat hemophilia A, a genetic disorder that impairs the body's ability to form blood clots. The structure of Moroctocog alfa (BDDrFVIII) is comprised of a heavy chain and a light chain, which are connected by a metal ion. The heavy chain contains the A1, A2, and B domains, while the light chain contains the A3, C1, and C2 domains.
The structure of Moroctocog alfa (BDDrFVIII) closely resembles the structure of endogenous FVIII, allowing it to effectively replace the missing or deficient FVIII in individuals with hemophilia A. This enables normal blood clotting to occur and helps prevent excessive bleeding.

Clinical application of Moroctocog alfa (BDDrFVIII)

Moroctocog alfa is produced using a technology called B-domain deleted (BDD), which removes a section of the factor VIII molecule and is designed to improve the stability and pharmacokinetic properties of the product.
The clinical application of Moroctocog alfa includes the following:
1. Treatment and Prevention of Bleeding Episodes: Moroctocog alfa is used for the on-demand treatment of bleeding episodes in patients with hemophilia A. It is also used as prophylaxis to prevent or reduce the frequency of bleeding episodes in individuals with severe hemophilia A.
2. Surgical Prophylaxis: Moroctocog alfa can be used as part of a prophylactic treatment regimen to prevent bleeding during and after surgical procedures in patients with hemophilia A.
3. Management of Hemophilia A: Moroctocog alfa is an important component of comprehensive care for patients with hemophilia A, helping to restore the missing factor VIII and improve the blood clotting process.
4. Home Treatment: Moroctocog alfa can be used for home treatment by patients or their caregivers, allowing for greater flexibility and independence in managing bleeding episodes and prophylactic treatment.
5. Prophylactic Therapy for Joint Health: Prophylactic treatment with Moroctocog alfa can help preserve joint health and prevent the development of joint damage in patients with hemophilia A.
6. Prevention of Hemarthrosis: Hemarthrosis, or bleeding into the joints, is a common complication of hemophilia A, and Moroctocog alfa can help prevent and manage this condition.