Compositions comprising solid particles
Described herein are isolated cell culture components such as, e.g., biologics and/or lipids, and methods for isolating cell culture components from a liquid cell culture medium. Methods of the present invention may include contacting a dehydration composition and a liquid cell culture medium comprising a target component to form a mixture; forming an at least partially dehydrated component in the mixture; and separating the at least partially dehydrated component from the mixture, thereby providing an isolated component. In some embodiments, the isolated component comprises the at least partially dehydrated component. In some embodiments, the isolated component is present in a composition (e.g., liquid phase) separated from the at least partially dehydrated component.
1. A composition comprising:
a plurality of particles, wherein each particle of the plurality of particles comprises an amorphous protein and the amorphous protein is present in each particle in an amount of at least 65% by weight of the particle,
wherein each particle of the plurality of particles is a solid particle that has a water content of less than 10% and a water activity of 0.25 or less, and
wherein the composition comprises aggregates of the protein in an amount less than 5% by weight of the protein in the composition.
2. The composition of claim 1 , wherein the protein is an antibody or a fragment thereof.
3. The composition of claim 1 , wherein the composition comprises aggregates of the protein in an amount less than 3% by weight of the protein in the composition.
4. The composition of claim 1 , further comprising a sugar.
5. The composition of claim 1 , further comprising a surfactant.
6. The composition of claim 1 , further comprising an antioxidant.
7. The composition of claim 1 , wherein the plurality of particles, upon contact with an aqueous solution, dissolve in the aqueous solution.
8. The composition of claim 1 , wherein the plurality of particles are suspended in the composition.
9. The composition of claim 8 , wherein the plurality of particles are suspended in an ester.
10. The composition of claim 8 , wherein the plurality of particles are suspended in a C1-C20 ester containing compound.
11. The composition of claim 1 , wherein the plurality of particles have a size of 2 μm to 20 μm.
12. The composition of claim 1 , wherein the protein in the plurality of particles has an activity, upon dissolution in a solution, that is within ±30% of the activity of the protein prior to the formation of the plurality of particles.
13. The composition of claim 1 , wherein the composition comprises at least 25% of the solid particles by weight of the composition.
14. The composition of claim 1 , wherein the composition comprises at least 50% of the solid particles by weight of the composition.
15. The composition of claim 1 , wherein the composition comprises at least 60% of the solid particles by weight of the composition.
16. The composition of claim 1 , wherein the composition, after storage at a temperature of about 4° C. to about 10° C. for at least 2 years, comprises aggregates of the protein in an amount less than 10% by weight of the protein.
17. The composition of claim 1 , wherein the protein, after storage of the composition at a temperature of about 4° C. to about 10° C. for at least 2 years, has an activity, upon dissolution in a solution, that is within ±30% of the activity of the protein prior to the formation of the plurality of particles.
18. The composition of claim 1 , wherein the composition, after storage at a temperature of about 25° C. for at least 1 year, comprises aggregates of the protein in an amount less than 10% by weight of the protein.
19. The composition of claim 1 , wherein the composition, after storage at a temperature of about 40° C. for at least 3 months, comprises aggregates of the protein in an amount less than 10% by weight of the protein.
20. The composition of claim 1 , wherein the plurality of particles are microspheres, wherein the protein of the microsphere retains at least 90% of its biological activity, and wherein the protein of the microsphere maintains a folded structure.
21. A composition comprising:
a solvent and a plurality of particles,
wherein each particle of the plurality of particles is a solid particle that comprises an amorphous protein and each particle of the plurality of particles has a water content of less than 10% and a water activity of less than 0.75,
wherein the composition comprises at least 25% of the solid particles by weight of the composition, and
wherein the composition comprises aggregates of the protein in an amount less than 5% by weight of the protein in the composition, and
wherein the solid particles of the plurality of particles are suspended in the solvent.
22. The composition of claim 21 , wherein the protein is an antibody or a fragment thereof.
23. The composition of claim 21 , further comprising a surfactant.
24. The composition of claim 21 , further comprising an antioxidant.
25. The composition of claim 21 , wherein the plurality of particles are microspheres.
26. The composition of claim 21 , wherein the solvent is an ester.
27. The composition of claim 21 , wherein the solvent is a C1-C20 ester containing compound.
28. The composition of claim 21 , wherein the protein in the plurality of particles has an activity, upon dissolution in a solution, that is within ±30% of the activity of the protein prior to the formation of the plurality of particles.
29. The composition of claim 21 , wherein the composition, after storage at a temperature of about 40° C. for at least 3 months, comprises aggregates of the protein in an amount less than 10% by weight of the protein.
30. The composition of claim 21 , wherein the composition comprises 40% to 60% of the solid particles by weight of the composition, wherein the amorphous protein is present in each particle of the plurality of particles in an amount of at least 65% by weight of the particle, and wherein the water activity of each particle of the plurality of particles is 0.25 or less.