Abstract: Provided are liquid and lyophilized recombinant Factor VIII formulations, including formulations for polymer-conjugated FVIII such as PEGylated Factor VIII.

Abstract: Provided are liquid and lyophilized rFVIII formulations, including full-length rFVIII (FL-rFVIII) formulations, B-domain deleted rFVIII (BDD-rFVIII) formulations, and BDD-rFVIII mutant (BDD-rVIII mutant) formulations. Also provided are liquid and lyophilized PEGylated rFVIII (PEG-rFVIII) formulations, including PEGylated full-length rFVIII (PEG-FL-rFVIII) formulations, PEGylated B-domain deleted rFVIII (PEG-BDD-rFVIII) formulations, and PEGylated BDD-rFVIII mutant (PEG-BDD-rFVIII mutant) formulations.

Abstract: The invention relates to a method for stabilizing a bulk solution of recombinant protein for frozen storage, which comprises providing a partially-purified solution of recombinant protein which has a monovalent salt concentration of at least 100 mM, and adding a carbohydrate to said solution in an amount sufficient that, upon freezing, the solution has a glass transition temperature of ?56° C. or higher.

Abstract: The invention relates to a method for stabilizing a bulk solution of recombinant protein for frozen storage, which comprises providing a partially-purified solution of recombinant protein which has a monovalent salt concentration of at least 100 mM, and adding a carbohydrate to said solution in an amount sufficient that, upon freezing, the solution has a glass transition temperature of ?56° C. or higher.

Abstract: The invention relates to a method for stabilizing a bulk solution of recombinant protein for frozen storage, which comprises providing a partially-purified solution of recombinant protein which has a monovalent salt concentration of at least 100 mM, and adding a carbohydrate to said solution in an amount sufficient that, upon freezing, the solution has a glass transition temperature of ?56° C. or higher.

Abstract: The invention relates to a method for stabilizing a bulk solution of recombinant protein for frozen storage, which comprises providing a partially-purified solution of recombinant protein which has a monovalent salt concentration of at least 100 mM, and adding a carbohydrate to said solution in an amount sufficient that, upon freezing, the solution has a glass transition temperature of ?56° C. or higher.

Abstract: A dehydrated composition is provided that includes freeze-dried erythrocytic cells. The invention further provides methods for loading a solute into a cell comprising disposing a cell in a solution having a solute concentration of sufficient magnitude to produce hyperosmotic pressure on the cell for transferring a solute from the solution into cell.

Abstract: A dehydrated composition is provided that includes freeze-dried erythrocytic cells. Alcohol (e.g., sterol or cholesterol) is at least partially removed from erythrocytic cells including erythrocytic membranes. After removal of at least part of the alcohol, the erythrocytic cells have a low phase transition temperature range, an intermediate phase transition temperature range, and a high phase transition temperature range. The erythrocytic cells may be loaded with an oligosaccharide (e.g., trehalose) which preserves biological properties during freeze-drying and rehydration. A process for increasing cooperativity of a phase transition of an erythrocytic cell. A process for preserving and/or increasing the survival of dehydrated erythrocytic cells, including storing dehydrated erythrocytic cells having a residual water content equal to or less than about 0.30 gram of water per gram of dry weight erythrocytic cells.

Abstract: A dehydrated composition is provided that includes freeze-dried erythrocytic cells. A method for loading a solute into a cell comprising disposing a cell in a solution having a solute concentration of sufficient magnitude to produce hyperosmotic pressure on the cell for transferring a solute from the solution into the cell. A method for retaining a solute in a cell.

Abstract: A method for reducing hemolysis in cells including washing cells in a solute solution having the capabilities of reducing cell hemolysis by at least about 0.50% for each 100 mOsm increase in osmolarity of the solute solution. A cell produced by the method for reducing hemolysis. The method permits removal of osmotically fragile cells from the population.

Abstract: A method for maintaining a viability level of a metabolite in a biological sample comprising disposing a biological sample into a solute solution comprising a solute and a chemical selected from the group consisting of a monosaccharide, a monosaccharide polyol, a cell metabolite-controlling agent, a salt, and mixtures thereof; and incubating the biological sample in the solute solution while maintaining a viability level of a metabolite in the biological sample.

Abstract: A dehydrated composition is provided that includes freeze-dried cells. A method for loading a solute into a cell comprising disposing a cell in a solution having at temperature of at least 25° C. and a solute concentration of sufficient magnitude to produce hyperosmotic pressure on the cell for transferring a solute from the solution into the cell. A method for reconstituting dried cells by drying loaded cells in a drying solution and reconstituting dried cells in a rehydration solution. A method for stabilizing cells by producing cells having an effective amount of a solute and a mean corpuscular hemoglobin greater than about 10.

Abstract: A dehydrated composition is provided that includes freeze-dried platelets. The platelets are loaded with trehalose which preserves biological properties during freeze-drying and rehydration. The trehalose loading is conducted at a temperature of from greater than about 25° C. to less than about 40° C., most preferably at 37° C., with the loading solution having trehalose in an amount from about 10 mM to about 50 mM. These freeze-dried platelets are substantially shelf-stable and are rehydratable so as to have a normal response to an agonist, for example, thrombin, with virtually all of the platelets participating in clot formation within about three minutes at 37° C.

Abstract: A dehydrated composition is provided that includes freeze-dried platelets. The platelets are loaded with trehalose which preserves biological properties during freeze-drying and rehydration. The trehalose loading is conducted at a temperature of from greater than about 25° C. to less than about 40° C., most preferably at 37° C., with the loading solution having trehalose in an amount from about 10 mM to about 50 mM. These freeze-dried platelets are substantially shelf-stable and are rehydratable so as to have a normal response to an agonist, for example, thrombin, with virtually all of the platelets participating in clot formation within about three minutes at 37° C.