STABLE FORMULATIONS OF NEISSERIA MENINGITIDIS rLP2086 ANTIGENS
AssigneeWyeth
InventorsLakshmi Khandke, Rasappa Arumugham, Bounthon Loun
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Abstract
The present invention relates to stable formulations of Neisseria meningitis rLP2086 Subfamily B Antigens in immunogenic compositions. The present invention also relates to methods of preserving the conformation of Neisseria meningitis rLP2086 Antigens and methods for determining the potency of Neisseria meningitis rLP2086 antigens.
Claims107
An immunogenic composition comprising a LP2086 (fHBP) Subfamily B polypeptide formulated so that the potency of the LP2086 (fHBP) Subfamily B polypeptide is stable over time.
An immunogenic composition comprising a detergent and a LP2086 (fHBP) Subfamily B polypeptide at a detergent-to-protein molar ratio of less than 10:1.
A method for stabilizing the potency of a LP2086 (fHBP) Subfamily B polypeptide in an immunogenic composition, said method comprising the step of (a) formulating the LP2086 (fHBP) Subfamily B polypeptide in a composition with a molar ratio of detergent to protein of between about 0.5:1 and about 10:1.
A method for stabilizing the potency of a LP2086 (fHBP) Subfamily B polypeptide in an immunogenic composition, said method comprising the step of (a) formulating the LP2086 (fHBP) Subfamily B polypeptide in a composition with between about 0.1 mg/ml and about 1 mg/ml aluminum and a molar ratio of detergent to protein of about 0.5:1 and about 10:1.
A method for determining the potency of a 2086 (fHBP) polypeptide in an immunogenic composition, said method comprising the steps of:
- (1) incubating a first monoclonal Ab and a second mAb with an immunogenic composition comprising a 2086 protein, wherein the first mAb is conjugated to a first tag that is used to capture the mAb and the second mAb is conjugated to a second tag that is detectable and wherein the first and second mAbs are directed to different conformational epitopes on a 2086 reference protein;
- (2) capturing the first mAb-bound 2086 protein using the first tag;
- and (3) detecting and quantifying the amount of captured second mAb-bound 2086 protein using the second tag.
Dependencies are inferred from the claim text.