Antibody formulations having optimized aggregation and fragmentation profiles
An antibody, preparation technology, applied in the field of antibody preparation with optimized aggregation and fragmentation properties
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[0123] 5.1 Methods of preparing antibody preparations
[0124] The present invention provides methods for preparing preparations of antibodies that immunologically specifically bind to an antigen of interest, or derivatives, analogs or fragments thereof. Such antibodies can be purified according to antibody purification methods known in the art. figure 1 with 2 It is another flow chart for preparing purified antibodies. In one embodiment, the method for preparing the liquid formulation of the present invention includes: using a semi-permeable membrane to set a suitable molecular weight (MW) cut-off value (such as intact antibody molecules and F(ab’) 2 Use 30kD cut-off value for fragments; 10kD cut-off value for antibody fragments such as Fab fragments) Concentrate the components containing purified antibodies or fragments to a concentration of about 15 mg / ml, about 20 mg / ml, about 30 mg / ml, and about 40 mg / Ml, about 50mg / ml, about 60mg / ml, about 70mg / ml, about 80mg / ml, about 90m...
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