Corifact
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Uses
Corifact is a Factor XIII Concentrate indicated for routine prophylactic treatment and peri-operative management of surgical bleeding in adult and pediatric patients with congenital FXIII deficiency.
History
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Other Information
Corifact, Factor XIII Concentrate (Human), is a heat-treated, lyophilized concentrate of coagulation factor XIII for reconstitution for intravenous use. Corifact (FXIII) consists of two A-subunits and two B-subunits, and is made from pooled human plasma. Each vial contains 1000-1600 units FXIII, 120 to 200 mg human albumin, 120 to 320 mg total protein, 80 to 120 mg glucose and 140 to 220 mg sodium chloride. Sodium hydroxide may have been used to adjust the pH.
All plasma used in the manufacture of Corifact is obtained from US donors and is tested using serological assays for hepatitis B surface antigen and antibodies to HIV-1/2 and HCV. The plasma is tested with Nucleic Acid Testing (NAT) for HCV, HIV-1, HAV and HBV and found to be non-reactive (negative), and the plasma is also tested by NAT for Human Parvovirus B19. Only plasma that passed virus screening is used for production, and the limit for Parvovirus B19 in the fractionation pool is set not to exceed 104 International Units of Parvovirus B19 DNA per mL.
Corifact is manufactured from cryo-depleted plasma into an ethanol precipitate, which is then purified by the following four steps:
- Precipitation/adsorption
- Ion exchange chromatography
- Heat-treatment (+60°C for 10 hours in an aqueous solution)
- Virus filtration over two 20 nm filters in series
The sterile filtered final bulk solution is filled into vials and lyophilized. These four manufacturing steps were independently validated in a series of in vitro experiments for their capacity to inactivate or remove both enveloped and non-enveloped viruses. Table 2 shows the virus clearance capacity of the Corifact manufacturing process, expressed as mean log10 reduction factor.
| Manufacturing Steps | Virus Reduction Factor (log10) | |||||
|---|---|---|---|---|---|---|
| Enveloped Viruses | Non-Enveloped Viruses | |||||
| HIV, Human immunodeficiency virus type 1, model for HIV-1 and HIV-2 | ||||||
| BVDV, bovine viral diarrhea virus, model for HCV | ||||||
| WNV, West Nile virus | ||||||
| PRV, pseudorabies virus, a model for large enveloped DNA viruses | ||||||
| HAV, Hepatitis A virus | ||||||
| CPV, canine parvovirus, model for B19V | ||||||
| B19V, Human parvovirus B19 | ||||||
| N/A, not applicable | ||||||
| n.d., not done | ||||||
|
||||||
| HIV | BVDV | WNV | PRV | HAV | CPV | |
| Al(OH)3 Adsorption / Vitacel® and Defibrination | n.d. | n.d. | n.d. | 6.9 | n.d. | n.d. |
| Ion Exchange Chromatography | 5.0 | 3.3 | n.d. | ≥8.0 | 3.4 | 3.7 |
| Heat Treatment | ≥7.7 | ≥8.1 | ≥7.4 | N/A* | 4.3 | 1.0† |
| 20 nm / 20 nm Virus Filtration | ≥6.1 | ≥5.0 | ≥7.4 | ≥6.4 | ≥5.6 | 6.1 |
| Cumulative Virus Reduction (log10) | ≥18.8 | ≥16.4 | ≥14.8 | ≥21.3 | ≥13.3 | 10.8 |
Sources
Corifact Manufacturers
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Csl Behring Gmbh
![Corifact (Factor Xiii Concentrate (Human)) Kit [Csl Behring Gmbh]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Corifact | Warner Chilcott (us), Llc
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2.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopausefemhrt therapy consists of a single tablet to be taken orally once daily.
2.2 Prevention of Postmenopausal Osteoporosisfemhrt therapy consists of a single tablet taken orally once daily.
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