Chuẩn bị dược phẩm sinh học khác nhau mà con người albumin huyết thanh (HSA) đã được mô tả như là một chất ổn định tiềm năng và b-Interferons g-Interferon Interleukin-2 Urokinase Erythropoietin mô hoạt hóa plasminogen Tumour yếu tố hoại tử đơn dòng kháng thể chuẩn bị g-Globulin chuẩn bị viêm gan B kháng nguyên bề mặt | THE DRUG MANUFACTURING PROCESS 151 Table . Some major excipient groups that may be added to protein-based biopharmaceuticals in order to stabilize the biological activity of the finished product Serum albumin Various individual amino acids Various carbohydrates Alcohols and polyols Surfactants Table . Various biopharmaceutical preparations for which human serum albumin HSA has been described as a potential stabilizer a- and b-Interferons Tissue plasminogen activator g-Interferon Tumour necrosis factor Interleukin-2 Monoclonal antibody preparations Urokinase g-Globulin preparations Erythropoietin Hepatitis B surface antigen conditions of low pH or elevated temperature it is stable for over 10 h at 60 C . It also displays excellent solubility characteristics. It is postulated that albumin stabilizers exert their stabilizing influences by both direct and indirect means. Certainly it helps decrease the level of surface adsorption of the active biopharmaceutical to the internal walls of final product containers. It also could act as an alternative target . for traces of proteases or other agents that could be deleterious to the product. It may also function to directly stabilize the native conformation of many proteins. It has been shown to be an effective cryoprotectant for several biopharmaceuticals . IL-2 tPA and various interferon preparations helping to minimize potentially detrimental effects of the freeze-drying process on the product. However the use of HSA is now discouraged due to the possibility of accidental transmission of blood-borne pathogens. The use of recombinant HSA would overcome such fears. Various amino acids are also used as stabilizing agents for some biopharmaceutical products Table . Glycine is most often employed and it as well as other amino acids has been found to help stabilize various interferon preparations as well as erythropoietin factor VIII Table . Amino acids carbohydrates and polyols that have found most .
