compositions, article of manufacture, methods for treating a cancer patient, for evaluating a composition, for evaluating biological activity, for producing a composition and for evaluating the fragmentation of a composition and variant of pertuzumab

摘要

"compositions, article of manufacture, methods for treating a cancer patient, for evaluating a composition, for evaluating biological activity, for producing a composition, and for evaluating the fragmentation of a composition and variant of pertuzumab" The present application discloses variants of pertuzumab. in particular, it discloses: an unpaired cysteine variant comprising unpaired cys23 / cys88 cysteines in one or both of the pertuzumab variable light domains, an un-fucosylated pertuzumab variant, a low molecular weight species (lmws) of pertuzumab, and a high molecular weight species (hmws) of pertuzumab. The application further discloses isolated variants, compositions, pharmaceutical compositions and articles of manufacture comprising the variants as well as production methods and characterizing the variants and compositions thereof.