Abstract: Provided are formulations of anti-CD38 antibodies suitable for subcutaneous administration to a subject in need thereof. The formulations include a high concentration of antibody, a viscosity lowering agent, a stabilizing agent, a buffering agent and a surfactant. In certain embodiments, the viscosity of the solution is at most 25 mPa·s, and the pH of the solution is 5.9 to 7.0. In certain embodiments, the anti-CD38 antibody is isatuximab. The formulations will find use in treating CD38+ hematological malignancies, including multiple myeloma, as well as autoimmune and inflammatory diseases, in humans.

Abstract: A storage-stable pharmaceutical composition includes an aqueous solution of at least an antibody-derived therapeutically active protein chosen amongst antibody, nanobody or fusion protein and an amount effective to stabilize the antibody-derived therapeutically active protein of at least one lauryldimethylamineoxide and/or of one of its amine oxide analogs.

Abstract: A process of lowering the viscosity of a solution includes preparing a solution comprising a compound of formula I, at a concentration in the final formulation of between 10 and 250 mM, and a protein having at least one antibody fragment whose concentration is between 50 and 350 mg/mL and whose pH is between 5 and 8. The compound lowers the viscosity of the solution, which is difficult to inject, by a value of at least 15% relative to the viscosity of a solution of at least one protein having at least one antibody fragment of the same concentration and of the same pH not containing the compound.

Abstract: A storage-stable pharmaceutical composition includes an aqueous solution of at least an antibody-derived therapeutically active protein chosen amongst antibody, nanobody or fusion protein and an amount effective to stabilize the antibody-derived therapeutically active protein of at least one lauryldimethylamineoxide and/or of one of its amine oxide analogs.

Abstract: A container containing a therapeutic protein, characterized in that chaperones molecules are bound by a molecular linker to an inner surface of the container. The linker being interposed between the surface and the chaperone.

Abstract: A process of lowering the viscosity of a solution includes preparing a solution comprising a compound of formula I, at a concentration in the final formulation of between 10 and 250 mM, and a protein having at least one antibody fragment whose concentration is between 50 and 350 mg/mL and whose pH is between 5 and 8. The compound lowers the viscosity of the solution, which is difficult to inject, by a value of at least 15% relative to the viscosity of a solution of at least one protein having at least one antibody fragment of the same concentration and of the same pH not containing the compound.

Abstract: A container containing a therapeutic protein, characterized in that chaperones molecules are bound by a molecular linker to an inner surface of the container. The linker being interposed between the surface and the chaperone.