Subcutaneous Formulations Of Anti-CD38 Antibodies And Their Uses

A pharmaceutical composition comprising:

• a) daratumumab,
• b) from about 5 mM to about 50 mM of a buffer,
• c) from about 100 mM to about 300 mM of a saccharide,
• d) from about 0.01% w/v to about 0.1% w/v of a surfactant, and
• e) from about 0.1 mg/mL to about 2.5 mg/mL methionine,
• wherein the pharmaceutical composition is at pH 5.0 to 6.0, and
• wherein the daratumumab in the pharmaceutical composition has a percentage (%) purity of at least 97.0% as measured by SDS-PAGE under non-reducing conditions, and
• wherein at least 98% of the daratumumab in the pharmaceutical composition is present as a monomer as measured by size exclusion separation.