Formulação reconstituída estável método para a preparação de uma formulação artigo manufaturado e uso da formação

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 STEVEN J. SHIRE, XANTHE M. LAM, JEFFREY L. CLELAND, JAMES ANDYA, SYLVIA SAU-YAN WU, CHUNG C. HSU, DAVID E. OVERCASHIER, JANET YU-FENG YANG
Format Patent
LanguagePortuguese
Published 02.03.1999
Edition6
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Abstract 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.
AbstractList 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.
Author DAVID E. OVERCASHIER
JAMES ANDYA
JEFFREY L. CLELAND
JANET YU-FENG YANG
CHUNG C. HSU
SYLVIA SAU-YAN WU
XANTHE M. LAM
STEVEN J. SHIRE
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– fullname: DAVID E. OVERCASHIER
– fullname: JANET YU-FENG YANG
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Snippet A stable lyophilized protein formulation is described which can be reconstituted with a suitable diluent to generate a high protein concentration reconstituted...
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SubjectTerms HUMAN NECESSITIES
HYGIENE
MEDICAL OR VETERINARY SCIENCE
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
Title Formulação reconstituída estável método para a preparação de uma formulação artigo manufaturado e uso da formação
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