Xyntha Description

See Table 1.

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Xyntha Vial Kit: Xyntha, Antihemophilic Factor (Recombinant) freeze-dried is supplied in kits that include single-use vials that contain nominally 250, 500, 1000, or 2000 IU per vial. Actual factor VIII activity in IU is stated on the label of each Xyntha Antihemophilic Factor (Recombinant) vial.
In addition, each Xyntha Antihemophilic Factor (Recombinant) kit contains: one pre-filled diluent syringe containing 4 mL 0.9% Sodium Chloride with plunger rod for assembly, one vial adapter, one sterile infusion set, two alcohol swabs, one bandage, one gauze, and one package insert.
Xyntha Solofuse: Xyntha Antihemophilic Factor (Recombinant), is supplied in a kit that includes the Xyntha freeze-dried powder that contain nominally 250, 500, 1000, 2000, or 3000 IU and 4 mL 0.9% Sodium Chloride solution for reconstitution in a prefilled dual-chamber syringe. Actual factor VIII activity in IU is stated on the label of each Xyntha Antihemophilic Factor (Recombinant) pre-filled dual-chamber syringe.
Drug Substance: Proper name: Antihemophilic Factor (Recombinant) [BDDrFVIII].
Chemical name: BDDrFVIII (B domain deleted recombinant factor VIII).
Molecular Formula and Molecular mass: Moroctocog alfa is expressed as a single-chain polypeptide containing 1438 amino acid residues, which is cleaved during processing to the mature, 2-chain form. The total molecular mass including glycosylation is approximately 173 kDa.
Physicochemical properties: Antihemophilic Factor (Recombinant) the active ingredient in Xyntha, is a recombinant coagulation factor VIII produced by recombinant DNA technology for use in therapy of factor VIII deficiency. Antihemophilic Factor (Recombinant) is a purified glycoprotein with an approximate molecular mass of 170 kDa consisting of 1438 amino acids. It does not contain the B-domain, which has no known function in the circulating form of factor VIII. The amino acid sequence of moroctocog alfa is comparable to the 90 + 80 kDa form of factor VIII. The post-translational modifications and in vitro functional characteristics of moroctocog alfa are comparable to those of endogenous factor VIII.
Product Characteristics: Antihemophilic Factor (Recombinant) is secreted by a genetically engineered Chinese hamster ovary (CHO) cell line. The CHO cell line has been extensively studied and found to be free of detectable viruses. The cell line is grown in a chemically-defined cell culture medium that does not contain any materials derived from human or animal sources. The purification process has been refined to affinity purify moroctocog alfa using a column chromatography method that employs a chemically synthesized affinity ligand, replacing the murine monoclonal antibody sepharose resin and eliminating a potential risk of viral contamination associated with the murine monoclonal antibody and its manufacture, and of hypersensitivity reactions to murine protein.
Antihemophilic Factor (Recombinant) is inherently free from the risk of transmission of human blood-borne pathogens, such as human immunodeficiency virus (HIV), hepatitis viruses and parvovirus, because it is not purified from human blood and is manufactured from a well-characterized cell line in the absence of human- or animal-derived materials. To further enhance the viral safety profile and provide additional assurance to the hemophilia A community, a solvent-detergent viral inactivation step and a virus-retaining nanofiltration step have been included during purification.
The protein is purified by a chromatography purification process that yields a high-purity, active product. The potency expressed in international units (IU) is determined using the chromogenic assay of the European Pharmacopoeia. The Pfizer In-House Recombinant Factor VIII Potency Reference Standard has been calibrated against the World Health Organization (WHO) International Standard for factor VIII activity using the one-stage clotting assay. This method of potency assignment is intended to harmonize Xyntha with clinical monitoring using a one-stage clotting assay. The specific activity of Xyntha is 5500 to 9900 IU per milligram of protein.