Stabilized Protein Crystals, Formulations Containing Them and Methods of Making Them
AssigneeAlthea Technologies, Inc.
InventorsAlexey L. MARGOLIN, Nazar K. KHALAF, Nancy L. ST. CLAIR, Scott L. RAKESTRAW, Bhami C. SHENOY
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Abstract
This invention relates to methods for the stabilization, storage and delivery of biologically active macromolecules, such as proteins, peptides and nucleic acids. In particular, this invention relates to protein crystals, formulations and compositions comprising them. Provided are methods and compositions for encapsulating proteins, glycoproteins, enzymes, antibodies, hormones and peptide crystals or crystal formulations into compositions for biological delivery.
Claims30
A formulation, said formulation comprising:
- (a) a protein crystal, and
- (b) at least one polymeric carrier, wherein said formulation is encapsulated within a matrix of said polymeric carrier such that the formulation is characterized by at least a 60 fold greater shelf life when stored at 50° C. than the soluble form of said protein in solution at 50° C., as measured by T1/2.
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A composition for the release of a protein, said composition comprising:
- (a) a protein crystal formulation, and
- (b) at least one polymeric carrier, wherein said formulation is encapsulated within a matrix of said polymeric carrier, and wherein said formulation is characterized by at least a 59 fold greater shelf life when stored at 40° C. and 75% humidity than the nonformulated form of said protein crystal when stored at 40° C. and 75% humidity, as measured by T1/2.
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A process for producing microspheres by encapsulating protein crystals, comprising the steps of:
- (a) suspending said protein crystals in a polymeric carrier dissolved in an organic solvent to produce a suspension of coated protein crystals;
- (b) transferring said suspension of coated protein crystals, polymeric carrier and organic solvent to an aqueous solution containing an emulsifier;
- and
- (c) hardening said polymeric carrier by evaporating the organic solvent in the presence of said emulsifier to produce said microspheres.
-187. (canceled)
Dependencies are inferred from the claim text.