PROTEIN FORMULATION

A stable lyophilized protein formulation is described which can be reconstituted with a suitable diluent to generate a high protein concentration reconstituted formulation which is suitable for subcutaneous administration. For example, anti-IgE and anti-HER2 antibody formulations have been prepared...

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Main Authors ANDYA JAMES, LAM XANTHE M, CLELAND JEFFREY L, SHIRE STEVEN J, OVERCASHIER DAVID E, WU SYLVIA SAU-YAN, HSU CHUNG C, YANG JANET YU-FENG
Format Patent
LanguageEnglish
Published 29.08.2013
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Summary:A stable lyophilized protein formulation is described which can be reconstituted with a suitable diluent to generate a high protein concentration reconstituted formulation which is suitable for subcutaneous administration. For example, anti-IgE and anti-HER2 antibody formulations have been prepared by lyophilizing these antibodies in the presence of a lyoprotectant. The lyophilized mixture thus formed is reconstituted to a high protein concentration without apparent loss of stability of the protein.
Bibliography:Application Number: US201213619576