Ivan R.S. Correia,Czeslaw H. Radziejewski,Wolfgang Fraunhofer,Nicholas William Warne,Angela Kantor
申请号:
US14534776
公开号:
US20150071944A1
申请日:
2014.11.06
申请国别(地区):
US
年份:
2015
代理人:
摘要:
The invention provides compositions and methods for inhibiting fractionation of immunoglobulins comprising a lambda light chain based on the observation that iron, in the presence of histidine, results in increased fragmentation of a recombinant fully human IgG molecule containing a lambda light chain due to cleavage in the hinge region. The invention further provides an aqueous pharmaceutical formulation comprising an antibody, or antigen-binding portion thereof, that binds the p40 subunit of IL-12/IL-23 and a buffer system comprising histidine, wherein the formulation has enhanced stability, including enhanced resistance to fragmentation.