Stabile isotonic lyophilized protein formulation

Details Stabile isotonic lyophilized protein formulation Stabile isotonic lyophilized protein formulation

A - Human Necessities

61

K

A61K 39/395 (2006.01) A61K 9/19 (2006.01) A61K 38/16 (2006.01) A61K 47/26 (2006.01)

Patent

CA 2226575

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.

Formulation de protéine lyophilisée stable pouvant être reconstituée au moyen d'un diluant approprié pour donner une formulation reconstituée à forte concentration en protéine se prêtant à une administration sous-cutanée. Par exemple, des formulations d'anticorps anti-IgE et anti-HER2 ont été préparées par lyophilisation de ces anticorps en présence d'un lyoprotecteur. Le mélange lyophilisé ainsi obtenu est reconstitué pour donner une forte concentration en protéine sans perte apparente de stabilité de la protéine.

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