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AssigneeAlthea Technologies, Inc.
InventorsKirill Yakovlevsky, Michael Shamashkin, Nazer Khalaf, Chandrika P. Govardhan, Chu W. Jung
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This invention relates to SPPs, spherical nanocrystalline composite particles or crystalline SPPs of biologically active proteins or compositions, including formulations, comprising such SPPs, spherical nanocrystalline composite particles or crystalline SPPs. More particularly, methods are provided for the production of SPPs, spherical nanocrystalline composite particles or crystalline SPPs of high concentrations of biologically active proteins, and for the preparation of stabilized SPPs, spherical nanocrystalline composite particles or crystalline SPPs for use alone, or in dry or slurry compositions. This invention also relates to methods for stabilization, storage and delivery of biologically active proteins using SPPs, spherical nanocrystalline composite particles or crystalline SPPs. The present invention further relates to methods using SPPs, spherical nanocrystalline composite particles or crystalline SPPs, or compositions or formulations comprising such SPPs, spherical nanocrystalline composite particles or crystalline SPPs, for biomedical applications, including biological delivery to humans and animals.
A crystalline spherical protein particle wherein said protein is an antibody or a single-chain Fv fragment of said antibody, wherein said protein has a conformation which is the same as that of the native, soluble counterpart of the protein, as indicated by an ELISA using a monoclonal antibody which specifically binds the native, soluble counterpart.
A crystalline spherical protein particle wherein said protein is an antibody or a single-chain Fv fragment of said antibody, wherein said protein has a β-sheet structural content that is less than about 20% different from the β-sheet structural content of the native, soluble counterpart of the protein, and has lost less than about 20% of the α-helical structural content of its native, soluble counterpart, as indicated by FTIR or Circular Dichroism (CD) spectroscopy.
A crystalline spherical protein particle wherein said protein is an antibody or a single-chain Fv fragment of said antibody, wherein said protein has about 100% of the biological activity of the native, soluble counterpart of the protein.
A crystalline spherical protein particle wherein said protein is an antibody or a single-chain Fv fragment of said antibody, wherein said protein has greater than about 50% to about 100% of the biological activity of the native, soluble counterpart of the protein as determined by a bioimmunoassay.
A crystalline spherical protein particle wherein said protein is an antibody or a single-chain Fv fragment of said antibody, wherein said antibody is a therapeutic antibody.
Dependencies are inferred from the claim text.