Stabil, isotonisk lyofiliseret proteinformulering

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 OVERCASHIER, DAVID E, LAM, XANTHE M, HSU, CHUNG C, WU, SYLVIA SAU-YAN, YANG, JANET YU-FENG, ANDYA, JAMES, CLELAND, JEFFREY L, SHIRE, STEVEN J
Format Patent
LanguageDanish
Published 08.09.2013
Subjects
CHEMISTRY
HUMAN NECESSITIES
HYGIENE
MEDICAL OR VETERINARY SCIENCE
METALLURGY
ORGANIC CHEMISTRY
PEPTIDES
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
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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: DK20040022777T