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.