Process for producing stable HIV Th-CTL peptides
AssigneeWyeth
InventorsLakshmi Khandke, Ranjit Sarpal, Xudong Cindy Yang
Life of this patent
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Abstract
A process for producing a stable formulation of hydrophobic HIV Th/CTL peptides first requires the preparation of a formulation buffer containing 12.5 mM succinic acid and 3% mannitol, and adjusting the pH of the formulation buffer to 1.7 to 2.1. The hydrophobic peptides are then dissolved in the formulation buffer, filtered and lyophilized. Prior to use, the lyophilized peptides are reconstituted with 12.5 mM sodium succinate, and then mixed with at least one adjuvant to produce an immunogenic composition that is stable at 2-8° C. for at least three hours.
Claims10
A process for solubilizing hydrophobic HIV Th/CTL peptides, comprising the steps of:
- (a) preparing an aqueous formulation buffer comprising 12.5 mM succinic acid and 3% mannitol;
- (b) adjusting the pH of the formulation buffer to 1.7 to 2.1;
- and
- (c) dissolving at least one hydrophobic HIV Th/CTL peptide in the formulation buffer.
A process for preparing a stable formulation of hydrophobic HIV Th/CTL peptides, comprising the steps of:
- (a) preparing an aqueous formulation buffer comprising 12.5 mM succinic acid and 3% mannitol, and adjusting the pH of the formulation buffer to 1.7 to 2.1;
- (b) dissolving a mixture of hydrophobic HIV Th/CTL peptides in the formulation buffer;
- (c) filtering the peptide formulation obtained in step (b);
- and
- (d) lyophilizing the filtrate, whereby the lyophillized HIV Th/CTL peptides are stable at 2-8° C. for at least 24 months.
Dependencies are inferred from the claim text.