Solid forms of anti-egfr-antibodies

Details Solid forms of anti-egfr-antibodies Solid forms of anti-egfr-antibodies

A - Human Necessities

61

K

A61K 9/14 (2006.01) A61P 35/00 (2006.01) C07K 16/28 (2006.01)

Patent

CA 2547446

The invention relates to solid forms of antibodies against the EGF receptor, especially precipitates and crystals of monoclonal antibodies against the EGF receptor, especially preferably Mab C225 (Cetuximab) and Mab h425 (EMD 72000), that create biologically active antibody proteins by dissolution or suspension in an aqueous medium. Said proteins can be obtained by precipitation of the antibody dissolved or suspended in the aqueous medium and/or one of the variants or fragments thereof by means of a precipitation reagent. The invention also relates to pharmaceutical preparations containing at least one solid form of the cited antibody in a precipitated non-crystalline form, a precipitated crystalline form or a soluble or suspended form, and optionally carrier and/or auxiliary substances and/or other pharmaceutical active ingredients, and to a method for producing inventive solid forms of anti-EGFR- antibodies.

La présente invention concerne des formes solides d'anticorps anti-récepteur EGF, en particulier des précipités et des cristaux d'anticorps monoclonaux anti-récepteur EGF, de préférence de Mab C225 (Cetuximab) et Mab h425 (EMD 72000), qui conduisent à la dissolution ou à la suspension en milieu aqueux pour donner une protéine d'anticorps à action biologique, et qui peuvent être obtenues par précipitation de l'anticorps qui est dissous ou en suspension dans un milieu aqueux, et/ou d'une variante et/ou d'un fragment de celui-ci, au moyen d'un réactif de précipitation. L'invention a également pour objet des préparations pharmaceutiques contenant au moins une forme solide des anticorps mentionnés ci-dessus dans une forme non cristalline, cristalline précipitée, ou soluble ou en suspension, ainsi qu'éventuellement des substances de support et/ou des substances auxiliaires et/ou d'autres principes actifs pharmaceutiques, ainsi qu'un procédé pour préparer lesdites formes solides d'anticorps anti-EGFR.

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