Antihemophilic factor, recombinant

Recombinate Antihemophilic factor Baxter Genetics Institute Hemophilia A... [Pg.695]

The PEG could stabilize proteins by two different temperature-dependent mechanisms. At lower temperatures, it is preferentially excluded from the protein surface but has been shown to interact with the unfolded form of the protein at higher temperatures, given its amphipathic nature (57). Thus, at lower temperatures, it may protect proteins via the mechanism of preferential exclusion, but at higher temperatures possibly by reducing the number of productive collisions between unfolded molecules. PEG is also a cryoprotectant and has been employed in Recombinate, a lyophilized formulation of recombinant Antihemophilic Factor, which utilizes PEG 3350 at a concentration of 1.5mg/mL. The low-molecular weight liquid PEGs (PEG 300-600) can be contaminated with peroxides and cause protein oxidation. If used, the peroxide content in the raw material must be minimized and controlled throughout its shelf life. The same holds true for polysorbates (discussed below). [Pg.300]

Bioclate or Recombinate (recombinant) [CHO-expressed glycoprotein-recombinant antihemophilic factor]... [Pg.310]

BHK cell-expressed recombinant antihemophilic factor] Healthcare 500, and 1000 IU single-dose vials... [Pg.316]

Recombinant factor VIII is stabilized with human serum albumin during purification and in the final product. Although albumin has an excellent safety record and no recombinant antihemophilic factors have been associated with virus transmission, there is still concern about the safety of products that contain human- or animal-derived components (50). A second-generation recombinant factor VIII product has been developed with a modified manufacturing process and a formulation in which the recombinant factor VIII is stabilized by sucrose instead of albumin (50). [Pg.1322]

C. Negrier, J. Astermark, 1. Pabinger, ). Di Paola et al. Surgical Evaluation of rAHF-PFM, an Advanced Category Recombinant Antihemophilic Factor Prepared Using a Plasma/Al-bumin-Free Method. Blood 2003 102(ll) Ab-stract 2944. [Pg.454]

Recombinant Antihemophilic Factor VIII 424 Recombinant blood factor 9 Recombinant factor VIII (rFVII) 420,459 Recombinant HB 1422 Recombinant hematopoietic growth factor 15 Recombinant hepatitis B surface antigen (rHBsAg) 3... [Pg.1877]

Blood coagulation factors antihemophilic factor (recombinant) eptacog alfa (activated) factor IX contentrate (human) factor IX (recombinant) moroctocog alfa... [Pg.611]

A. General description The active substance in ReFacto is antihemophilic factor (recombinant), a 1438 amino-acid glycoprotein (approximately 170 kDa) that is produced in engineered Chinese hamster... [Pg.147]

Pharmacokinetics In a pharmacokinetic study of previously treated patients, the circulating mean half-Ufe for ReFacto was 14.5 5.3 hours (range 7.6-27.7 hours), which was not significantly different from plasma-derived antihemophilic factor (human), which had a mean half-life of 13.7 3.4 hours (range 8.8-23.7 hours). Pharmacokinetic studies on 66 patients showed the circulating mean half-life for rAHF (Recombinate) to be 14.4 + 4.9 hours, which was not significantly different from a plasma-derived human antihemophilic factor, which had a mean half-life of 14.0 + 3.9 hours. One study determined a mean clearance of 127 mF min per kg. [Pg.149]

E Role in therapy Antihemophilic factor is indicated for the treatment of bleeding episodes or perioperative treatment in patients with hemophilia A. Prophylactic use has also been advocated for the prevention and/or reduction of bleeding episodes. The largest issue in treatment with antihemophilic factor is the choice of formulations because of the relative risk of viral transmission. Recombinant factor VIII has the lowest risk of transmission of blood-borne viruses, but its use may be limited due to cost and availability. [Pg.149]

H. Other considerations Antihemophilic factor (recombinant) has been designated an orphan product for use in the treatment or prophylaxis of bleeding in hemophilia A, or prophylaxis before surgery. [Pg.149]

Hematologic Antihemophilic factor, and coagulation human recombinant... [Pg.453]

Antihemophilic factor-human recombinant heavy and light chains combination (factor VIII) produced in CHO cells... [Pg.454]

Antihemophilic factor, human recombinant factor VIII produced in BHK cells... [Pg.478]

Factor VIII, rDNA, Mab purifJBaxter [BIO] Antihemophilic factor (recombinant) [FDA] Antihemophilic factor [USAN]... [Pg.501]

Antihemophilic factor USP [USP] Blood-coagulation factor VIII, complex [CAS] Factor VIII, recombinant [SY]... [Pg.501]

Antihemophilic factor [factor VIII, AHF] (Alphanate, Bioclate, Helixate, Hemofil M, Koate-HP, Kogenate, Monoclate, Recombinate, others)... [Pg.772]

Antihemophilic factor) Corporation [BHK cells-expressed recombinant human protein]... [Pg.319]

Summary Basis for Approval,2000. Antihemophilic Factor (recombinant) Refacto . http //www.fda.gov/cber/sba/ahfgen030600S.pdf... [Pg.679]

Lusher J, Abildgaard C, Arkin S, Mannucci PM, Zimmermann R, Schwartz L, Hurst D. Human recombinant DNA-derived antihemophilic factor in the treatment of previously untreated patients with hemophiha A final report on a hahmark clinical investigation. J Thromb Haemost 2004 2 574-83. [Pg.680]

Coagulation factors factor VII antihemophilic factor, factor IX (human, recombinant)... [Pg.36]

Abshire TC, Brackmann HH, Scharrer I, Hoots K, Gazengel C, Powell JS, Gorina E, Kellermann E, Vosburgh E. Sucrose formulated recombinant human antihemophilic factor VIII is safe and efficacious for treatment... [Pg.1323]

Since trace amounts of mou.se or ham.ster protein may iiipuhfy with recombinant factor VIII, one. should he cau-iiou when administering the drug to individuaks with known hyperscnsitiviiy to plasma-derived antihemophilic factor or with hypersensitivity to biological preparations with trace ammint.s nf mouse or hamster proteins. [Pg.185]

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