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Helixate® FS is a recombinant antihemophilic factor indicated for:
Helixate FS is not indicated for the treatment of von Willebrand disease.
Helixate FS Antihemophilic Factor (Recombinant) is a coagulation factor VIII produced by recombinant DNA technology. It is produced by Baby Hamster Kidney (BHK) cells into which the human factor VIII gene has been introduced.8 The cell culture medium contains Human Plasma Protein Solution (HPPS) and recombinant insulin, but does not contain any proteins derived from animal sources. Helixate FS is a purified glycoprotein consisting of multiple peptides including an 80 kD and various extensions of the 90 kD subunit. It has the same biological activity as factor VIII derived from human plasma. No human or animal proteins, such as albumin, are added during the purification and formulation processes of Helixate FS.
The purification process includes a solvent/detergent virus inactivation step in addition to the use of the purification methods of ion exchange chromatography, monoclonal antibody immunoaffinity chromatography, along with other chromatographic steps designed to purify recombinant factor VIII and remove contaminating substances.
Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents.9-13 Several of the individual production and raw material preparation steps in the Helixate FS manufacturing process have been shown to decrease TSE infectivity of that experimental model agent. These TSE reduction steps include the Fraction II+III separation step for HPPS (6.0 log10) and an anion exchange chromatography step (3.6 log10).
Helixate FS is formulated with the following as stabilizers (see Table 6) in the final container and is then lyophilized. The final product does not contain any preservative. It is a sterile, nonpyrogenic powder preparation for intravenous injection. Intravenous administration of sucrose contained in Helixate FS will not affect blood glucose levels.
| Stabilizer | 250 IU, 500 IU, 1000 IU | 2000 IU, 3000 IU |
|---|---|---|
|
Sucrose |
0.9–1.3% |
0.9–1.2% |
|
Glycine |
21–25 mg/mL |
20–24 mg/mL |
|
Histidine |
18–23 mmol/L |
17–22 mmol/L |
Table 7 lists the inactive ingredients/excipients also contained in the final product.
| Inactive Ingredient/Excipient | 250 IU, 500 IU, 1000 IU | 2000 IU, 3000 IU |
|---|---|---|
|
Sodium |
27–36 mEq/L |
26–34 mEq/L |
|
Calcium |
2.0–3.0 mmol/L |
1.9–2.9 mmol/L |
|
Chloride |
32–40 mEq/L |
31–38 mEq/L |
|
Polysorbate 80 |
64–96 μg/mL |
64–96 μg/mL |
|
Sucrose |
28 mg/vial |
52 mg/vial |
|
Imidazole, tri-n-butyl phosphate, and copper |
Trace amounts |
Trace amounts |