1 / 10

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

tracy
Download Presentation

Octanine F – Factor IX at its Peak

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related