Stable protein: phospholipid compositions and methods
AssigneeAmgen Inc.
InventorsDavid Collins, Younsik Cha, David Brems
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Abstract
The invention relates to stable compositions of proteins and related methods wherein a protein capable of transitioning into the molten globular state is contacted with a negatively charged lipid vesicle, thereby stabilizing the protein against thermally-induced aggregation, denaturation, and loss of activity. The protein:phospholipid complex directly stabilizes the secondary and tertiary structure of the protein, and the compositions are useful in high temperature formulations and in novel delivery vehicles.
Claims42
A composition comprising a cytokine mixed with a pre-formed intact phospholipid liposome vesicle, said liposome vesicle composed of negatively charged phospholipids, wherein said composition has at least a 25:1 (mole:mole) ratio of liposome:cytokine, to form a liposome-cytokine complex wherein only a portion of the cytokine is inserted into the lipid portion of the liposome vesicle, wherein said liposome-cytokine complex is directly stabilized against unfolding of the secondary structure of said cytokine, and wherein said composition has improved shelf life.
A method of preparing a liposome-cytokine composition comprising mixing a cytokine with a pre-formed intact phospholipid liposome vesicle, wherein said liposome vesicle is negatively charged, wherein said composition has at least a 25:1 (mole:mole) ratio of liposome:cytokine, wherein only a portion of said cytokine is inserted into the lipid portion of said liposome vesicle, wherein said liposome-cytokine complex is directly stabilized against unfolding of the secondary structure of said cytokine, wherein said composition has improved shelf life, and obtaining said liposome-cytokine composition.
Dependencies are inferred from the claim text.