Scientific Brochure
Kogenate® FS Antihemophilic Factor (Recombinant), Formulated with Sucrose
The original therapy for hemophilia A was Factor VIII (FVIII) replacement with human plasma or cryoprecipitate. This approach was inadequate because of the large volume of plasma and extraneous protein infused to achieve hemostasis. These products were also suboptimal because they could not undergo any virus-inactivation or reduction process.
Today's ultra-high purity FVIII products are highly concentrated; for example, Kogenate FS has up to four-hundred-fold the concentration of factor VIII in comparison with human plasma. The resulting injection volume is small, allowing convenient home treatment of bleeding episodes.
Kogenate FS is the second-generation recombinant Factor VIII product exclusively researched, developed, and manufactured by Bayer. It eliminates the use of human albumin in both the purification process and final formulation. Kogenate FS offers patients excellent tolerability, efficacy, and convenience.
| Safety from viruses and prions |
Recombinant source - expressed in mammalian cell line without the addition of bovine proteins to the culture |
Proven 15-year record with Kogenate® or Kogenate® FS with no confirmed virus transmissions
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| Sucrose formulation -No addition of human albumin during purification or as a stabilizer in final formulation |
Further risk reduction of virus or prion transmission
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| State-of-the-art award-winning continuous perfusion manufacturing process, innovative purification such as chelate chromatography, and quality assurance with continuous quality improvement process |
Long-term commitment by Bayer to improving hemophilia care |
| Effective and validated virus/prion inactivation and removal steps in Kogenate® FS purification process |
Confidence in safety of treatment |
| General safety |
Recombinant, homogenous protein |
Minimal rate of adverse events, predictable clinical response |
| Full-length, native human FVIII molecule |
Low risk of neoantigenicity |
| Expressed in mammalian cells necessary for post-translational modification to ensure proper activity and functionality |
rFVIII most similar to natural protein present in human plasma |
| Final product contains trace amounts of mouse and hamster proteins |
| Efficacy |
Extensive clinical testing |
Predictable clinical response |
| Functional nonmodified human rFVIII |
No increase in inhibitor development |
| Natural structure of protein domains |
Predictable excellent hemostasis |
| Over 15 years worldwide clinical experience with rFVIII; extensive international trials with Kogenate FS® |
Confidence in using a product from a company with over 20 years experience in FVIII production |
| Efficacy comparable to Kogenate® |
Predictable clinical response |
| Convenience |
Low diluent injection volume (2.5mL) |
Rapid infusion time |
| Peel-off adhesive vial label |
Simplified documenation with infusion log recording; better patient compliance |
In our quest to improve hemophilia care, Bayer HealthCare has pioneered the development of a nonplasma source for the FVIII molecule using recombinant DNA technology. Our goal became a reality in the late 1980's with the initiation of clinical trials of Kogenate® Antihemophilic Factor (Recombinant), a recombinant replacement therapy formulated with albumin. The structure and properties of this recombinant molecule are similar to those of FVIII derived from human plasma.
Today, Kogenate® FS Antihemophilic Factor (Recombinant), Formulated with Sucrose, represents the latest important step for non-plasma-derived FVIII products.
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