The present invention is directed to stable formulations of modified antibodies, each comprising an antibody fragment in an aqueous solution covalently attached to at least one nonproteinaceous polymer, such as poly(ethyleneglycol), through a succinimide moiety. CDP870 is an example of one such modified antibody. The formulations of the present invention include a buffer that maintains the solution at a pH of 3.5 to about 6, wherein all components of the modified antibody, including a succinimide ring of the succinimide moiety, are stable.
本发明涉及修饰
抗体的稳定制剂,每种
抗体都包括
水溶液中的
抗体片段,通过琥珀
酰亚胺分子与至少一种非蛋白聚合物(如聚
乙二醇)共价连接。CDP870 就是这种修饰
抗体的一个例子。本发明的制剂包括一种缓冲液,可使溶液的 pH 值保持在 3.5 至 6 左右,其中修饰
抗体的所有成分,包括琥珀
酰亚胺分子的琥珀
酰亚胺环,都是稳定的。