Low acidic species compositions and methods for producing and using the same

摘要

The instant invention relates to low acidic species (AR) compositions comprising a protein, e.g., an antibody, or antigen-binding portion thereof, and methods, e.g., cell culture and/or protein purification methods, for producing such low AR compositions. Methods for using such compositions to treat a disorder, e.g., a disorder in which TNFα is detrimental, are also provided.

主权项

1. A method of making a pharmaceutical composition, comprising mixing
(a) 25-100 mg of a low acidic species composition comprising adalimumab, wherein the low acidic species composition comprises less than 10% total acidic species of adalimumab, wherein the acidic species of adalimumab have a net negative charge relative to the adalimumab main species and the acidic species comprise species selected from the group consisting of charge variants, structure variants, fragmentation variants and any combinations thereof; wherein the acidic species of adalimumab do not include process-related impurities selected from the group consisting of host cell proteins, host cell nucleic acids, chromatographic materials and media components, and wherein said low acidic species adalimumab composition demonstrates increased cartilage penetration as compared to a non-low acidic species composition of adalimumab; and (b) a pharmaceutically acceptable carrier, thereby making a pharmaceutical composition.