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Octanine F – Factor IX at its Peak

Octanine F – Factor IX at its Peak. Very High Purity Factor IX Virus Inactivation and Elimination Haemophilia B Treatment and Prophylaxis. Octanine F Features at a Glance. Gently, highly purified Factor IX enriched 10,000fold over plasma Specific activity 150 to 200 IU/mg

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Octanine F – Factor IX at its Peak

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  1. Octanine F – Factor IX at its Peak Very High Purity Factor IX Virus Inactivation and Elimination Haemophilia B Treatment and Prophylaxis

  2. Octanine F Features at a Glance • Gently, highly purified Factor IX enriched 10,000fold over plasma Specific activity 150 to 200 IU/mg Non denatured, fully active • Safe in clinical use Effective and well-tolerated Non thrombogenic Non immunogenic • Virus inactivation and elimination High quality starting plasma Solvent / Detergent (S/D) treatment Nanofiltration

  3. Octanine F – Indications • Prophylaxis and treatment of bleeding in all forms of Haemophilia B • Dosage

  4. Octanine F Manufacturing Process Cryoprecipitate supernatant plasma Virus removal: Nanofiltration Ion exchange capture Sterile filtration, filling Ultrafiltration/Diafiltration Lyophilisation Ion exchange chromatography Quality Control and Batch Release S/D virus inactivation OCTANINE F Affinity chromatography

  5. Octanine F – Viral Safety: Conclusion • Octanine F fulfils all current requirements for virus safety set out by regulatory bodies, such as the Committee for Proprietary Medicinal Products* • Two effective steps against lipid enveloped viruses • One effective step against non enveloped viruses • A combination of methods based on different principles of action • Inactivation/removal with a high safety margin • Rapid virus inactivation • Robustness in the event of process variations • Validation of each step with a wide variety of viruses • An individual step efficacy equivalent to 4 log10 • Other process steps provide additional safety *CPMP/BWP/268/95, 1996. CPMP/BWP/269/95 rev 3., 2001

  6. Octanine F – Purified, Non Denatured Factor IX • Gentle purification steps avoid undesired Factor IX activation • Octanine F: Non denatured factor IX • Octanine F: Non activated factor IX A: Molecular weight markers B: Activated factor IX (Sigma) C: Non activated factor IX, Octanine F

  7. Octanine F – Purity • Octanine F is a high purity preparation of plasma-derived factor IX • Octanine F specific activity is in the range of 150 to 200 IU/mg of protein • Non detectable: Activated factor IX, as well as factors II, VII and X and their activated derivatives (IIa, VIIa, Xa)

  8. Octanine F – Pharmacokinetics

  9. Octanine – Clinical Experience • Octanine F at a mean dosage of 22.5 IU per kg BW for one or two treatment days was enough to ensure haemostasis in 93 % of cases in the treatment of acute bleeding • Octanine F efficacy was rated as “excellent” or “good” in 98 % of all cases • Octanine F has been used successfully in surgery

  10. Octanine F at a Glance – In Daily Clinical Use • Good clinical experience Excellent general safety Effective in prophylaxis Effective in bleeding control Effective in surgery Well-tolerated • Convenient handling Small injection volume Easy documentation Pull-off labels Dissolves rapidly • Presentation • Storage and shelf-life 24 months shelf-life at + 4 °C to + 8 °C. Do not freeze. Protect from light

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