ABSTRACT
Recombinate is indicated for the prevention and control of bleedings in patients suffering from hemo philia A. It is also indicated in the prophylaxis for surgery
Manufacturer: Baxter Healthcare Corporation, Hyland Immuno, Glendale, CA 91203, https://www.baxter.com/
Marketing: Baxter Healthcare Corporation, Hyland Immuno, Glendale, CA 91203, https://www.baxter.com/
Manufacturing
The recombinant antihemophilic factor (rAHF) is a glycoprotein very similar to the naturally occurring human coagulation factor VIII. It is produced in CHO cells using recombinant DNA technology. The glycoprotein is coexpressed with von Willebrand’s factor, which stabilizes rAHF in a noncovalently linked complex during production. Purification involves a number of chromatographic steps, including immunoaffinity chromatography using murine monoclonal antibodies against the heavy chain of rAHF. The purified rAHF consists of a combination of heterologous heavy and light chains very similar to the natural human glycoprotein. The final product consists of rAHF, human serum albumin (as a stabilizer), calcium, polyethylene glycol, sodium, histidine, polysorbate 80, traces of bovine and hamster proteins from the culture, murine protein from the purification, and von Willebrand’s factor.
