Polypeptide microparticles
AssigneeSurModics, Inc.
InventorsJoram Slager, John V. Wall
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Abstract
The invention provides polypeptide microparticles and methods for the preparation thereof using a nucleating agent.
Claims18
A polypeptide microparticle comprising an antibody or an antibody fragment polypeptide and a nucleus or nuclei, the nucleus or nuclei comprising a nucleating agent, wherein the polypeptide is present in an amount of 90% or greater in the polypeptide microparticle by weight, and wherein the polypeptide microparticle has a substantially spherical shape and a diameter in the range of 0.3 μm to 10 μm, and having a weight ratio of nucleating agent to polypeptide in the range of about 1:100 to 1:10,000, respectively.
A microparticle set comprising a plurality of polypeptide microparticles comprising an antibody or an antibody fragment polypeptide, wherein polypeptide is present in an amount of 90% or greater in the polypeptide microparticles of the set and individual polypeptide microparticles in the set comprise a nucleus or nuclei comprising a nucleating agent, wherein the microparticles have a weight ratio of nucleating agent to polypeptide in the range of about 1:100 to 1:10,000, respectively, and wherein the set has a degree of monodispersity of 5 or less.
A polypeptide microparticle formed according to a method comprising steps of
- coalescing antibody or an antibody fragment polypeptides with a nucleating agent to form polypeptide nuclei, wherein coalescing is performed in solution;
- mixing a phase separation reagent with the solution to further coalesce polypeptide around the nuclei;
- cooling the mixture;
- and
- removing all or a portion of the phase separation reagent from the mixture, where, in the polypeptide microparticles that are formed, polypeptide is present in an amount of 90% or greater of the weight of the microparticle and wherein the nucleating agent and polypeptide are present in the microparticles at weight ratio in the range of about 1:100 to 1:10,000, respectively.
A therapeutic composition comprising polypeptide microparticles and configured for administration to a subject, wherein the polypeptide microparticles comprise an antibody or an antibody fragment polypeptide
- and a nucleus or nuclei, the nucleus or nuclei comprising a nucleating agent, wherein the polypeptide is present in an amount of 90% or greater in the polypeptide microparticle by weight, wherein the microparticles have a weight ratio of nucleating agent to polypeptide in the range of about 1:100 to 1:10,000, respectively, wherein the polypeptide microparticle has a substantially spherical shape and a diameter in the range of 0.3 μm to 10 μm, and wherein the polypeptides can be released from the microparticles and provide a therapeutic effect following administration to the subject.
Dependencies are inferred from the claim text.