Stabilizing excipients used in final product formulations

Stabilizing excipients used in final product formulations 

A range of various substances may be added to a purified (polypeptide) biopharmaceutical product in order to stabilize that product (Table 3.22). Such agents can stabilize proteins in a number of different ways. Specific examples include  

Various individual amino acids Various carbohydrates Alcohols and polyols Surfactants 

Tissue plasminogen activator Tumour necrosis factor Monoclonal antibody preparations y-Globulin preparations Hepatitis B surface antigen 

Various amino acids are also used as stabilizing agents for some biopharmaceutical products (Table 3.24). 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, 

However, the use of HSA in now discouraged due to the possibility of accidental transmission of blood-borne pathogens. The use of recombinant HSA would overcome such fears. 

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