Antibody formulation
AssigneeNovartis AG
InventorsMarta COSENZA, Christoph Heusser, Julia Neugebauer, Eveline Schaadt, Stefanie Urlinger, Maximillan Woisetschlaeger
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Abstract
Anti-BAFFR antibodies are formulated as lyophilisate or liquid formulation. The lyophilisates can be reconstituted to give a solution with a high concentration of the antibody active ingredient for delivery to a patient without high levels of antibody aggregation. The lyophilisate can be reconstituted with an aqueous reconstituent to provide an aqueous composition in which the antibody has a concentration of at least 50 mg/ml. The lyophilisate or aqueous pharmaceutical composition may include one or more of a sugar, a buffering agent, a surfactant, and/or a free amino acid.
Claims10
A method of treating a disease or disorder that is mediated by BAFF receptor or that can be treated by killing or depleting B cells, comprising administering to a subject, a lyophilized formulation comprising
- (i) an anti-BAFFR antibody wherein the antibody has a concentration of 20-120 mg/ml, and wherein said anti-BAFFR antibody includes heavy chain CDR1, CDR2 and CDR3 of SEQ ID NOs 3, 4 and 5 respectively, and light chain CDR1, CDR2 and CDR3 of SEQ ID NOs:
- 6, 7 and 8,
- (ii) a stabilizer,
- (iii) a buffering agent,
- (iv) a surfactant, and optionally
- (v) an amino acid.
Dependencies are inferred from the claim text.