Antibody formulation
AssigneeNovartis AG
InventorsClaudia Mueller, Matthias Willmann
Life of this patent
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Abstract
Anti-CD40 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.
Claims32
A lyophilised formulation prepared by lyophilising an aqueous formulation having a pH of 5.0-7.0 and comprising
- (i) an anti-CD40 antibody wherein the antibody has a concentration of 20-150 mg/ml, and wherein said anti-CD40 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 stabiliser,
- (iii) a buffering agent,
- (iv) a surfactant, and optionally
- (v) an amino acid.
The aqueous pharmaceutical composition of claim 8, wherein the reconstitution factor is 1:3.
An aqueous pharmaceutical composition having a pH of 5.0 to 7.0 comprising
- (i) an anti-CD40 antibody wherein the antibody has a concentration of at least 50 mg/ml, and wherein said anti-CD40 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 stabiliser,
- (iii) a buffering agent,
- (iv) a surfactant, and optionally
- (v) an amino acid.
Dependencies are inferred from the claim text.