FIELD: medicine.
SUBSTANCE: invention relates to crystalline forms of antibodies against EGF receptor, in particular, Mab C225 (cetuximab) and Mab h425 (EMD 72000), which as a result ensure obtaining biologically active antibody protein by dissolving or suspending in water medium. Such inventions relate to method of obtaining crystalline forms of anti- EGFR antibodies. Essence of method lies in the following: antibody and/or one of its versions and/or fragments, dissolved or suspended in water solution, are precipitated by means of precipitating agent. Invention also relates to pharmaceutical compositions, including at least one crystalline form of Mab C225 (cetuximab) or Mab h425 (EMD 72000), and optionally fillers and/or auxiliary substances and/or additional pharmaceutically active ingredients.
EFFECT: pharmaceutical compositions with antibodies Mab C225 (cetuximab) and Mab h425 (EMD 72000), obtained by dissolving or suspending in water medium have higher resistance to stress conditions, such as higher temperature, atmospheric humidity and do not contain toxic auxiliary substances.
8 ex
Authors
Dates
2010-08-27—Published
2004-11-12—Filed