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 or nucleic acid crystals, formulations and compositions
comprising them. Methods are provided for the crystallization of proteins
and nucleic acids and for the preparation of stabilized protein or
nucleic acid crystals for use in dry or slurry formulations. The present
invention is further directed to encapsulating proteins, glycoproteins,
enzymes, antibodies, hormones and peptide crystals or crystal
formulations into compositions for biological delivery to humans and
animals. According to this invention, protein crystals or crystal
formulations are encapsulated within a matrix comprising a polymeric
carrier to form a composition. The formulations and compositions enhance
preservation of the native biologically active tertiary structure of the
proteins and create a reservoir which can slowly release active protein
where and when it is needed. Methods are provided preparing stabilized
formulations using pharmaceutical ingredients or excipients and
optionally encapsulating them in a polymeric carrier to produce
compositions and using such protein crystal formulations and compositions
for biomedical applications, including delivery of therapeutic proteins
and vaccines. Additional uses for the protein crystal formulations and
compositions of this invention involve protein delivery in human food,
agricultural feeds, veterinary compositions, diagnostics, cosmetics and
personal care compositions.