Protein-based drug products using monoester-free polysorbate detergent
AssigneeNovavax, Inc.
InventorsMarco CACCIUTTOLO, Ernest MAYNARD, Daniel SCOTT
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Abstract
Compositions include a biological component and polysorbate, where the polysorbate is free of monoesters. The invention also provides pharmaceutically acceptable carriers and buffers comprising monoester-free polysorbate, detergent-core nanoparticles comprising monoester-free polysorbate, methods for producing the monoester-free polysorbate, and methods of manufacturing the pharmaceutical compositions using a monoester-free polysorbate.
Claims20
A pharmaceutical nanoparticle comprising an active polypeptide ingredient associated with a polysorbate core, wherein the polysorbate is substantially free of monoesters.
A method of making a pharmaceutical nanoparticle, comprising:
- i) providing a polysorbate;
- ii) separating a monoester-free fraction of the polysorbate from a monoester fraction of the polysorbate;
- and
- iii) combining the monoester-free fraction of the polysorbate with an active polypeptide ingredient.
A method of making a pharmaceutical nanoparticle, comprising:
- i) providing a protein extract comprising an extraction detergent;
- ii) contacting the protein extract with an affinity resin;
- and
- iii) eluting protein bound to the affinity resin with a buffer comprising a monoester-free polysorbate to obtain the pharmaceutical nanoparticle.
A pharmaceutically acceptable buffer comprising a monoester-free polysorbate.
A composition, comprising a biological component and a monoester-free polysorbate.
Dependencies are inferred from the claim text.