摘要:
The invention relates to pharmaceutical formulations comprising a protein and free methionine in combination with one or more compounds capable of preventing the oxidation of aromatic amino acid residues within a protein. More specifically, the invention relates to stabilized, pharmaceutically effective preparations of oxidation-sensitive therapeutic agents. The invention further relates to a method of inhibiting the oxidation of such therapeutic agents.
摘要:
The invention provides methods of reducing fouling of ultrafiltration membranes in processes wherein virus particles are removed from aqueous solutions comprising virus particles and at least one protein by adding a surfactant or non-surfactant, non-ionic agent to the aqueous solution prior to filtration. The invention also provides methods to dissociate protein aggregates or to reduce the formation of protein aggregates by adding a surfactant or non-surfactant, non-ionic agent to the protein solution.
摘要:
The invention provides a method for reducing aggregation and inhibiting flocculation of a macromolecule, such as a protein, under physiological conditions, by the addition of certain cyclodextrins (CDs). The invention also provides a method to minimize inflammation at the injection site during subcutaneous administration of a macromolecule and pharmaceutical formulations for such administration. Further the invention provides methods of treating a CD20 positive cancer or an autoimmune disease, comprising administering a humanized anti-CD20 antibody in a pharmaceutical formulation of the invention. The invention further provides an in vitro dialysis method to evaluate the ability of an excipient to reduce aggregation of an antibody or other macromolecule under physiological conditions.
摘要:
The present invention relates to polypeptide formulations with reduced viscosity and methods of making and using polypeptide formulations with reduced viscosity.
摘要:
The invention provides methods of reducing fouling of ultrafiltration membranes in processes wherein virus particles are removed from aqueous solutions comprising virus particles and at least one protein by adding a surfactant or non-surfactant, non-ionic agent to the aqueous solution prior to filtration. The invention also provides methods to dissociate protein aggregates or to reduce the formation of protein aggregates by adding a surfactant or non-surfactant, non-ionic agent to the protein solution.
摘要:
The invention relates to pharmaceutical formulations comprising a protein and free methionine in combination with one or more compounds capable of preventing the oxidation of aromatic amino acid residues within a protein. More specifically, the invention relates to stabilized, pharmaceutically effective preparations of oxidation-sensitive therapeutic agents. The invention further relates to a method of inhibiting the oxidation of such therapeutic agents.
摘要:
The invention provides a method for reducing aggregation and inhibiting flocculation of a macromolecule, such as a protein, under physiological conditions, by the addition of 5% to 20% polyvinylpyrrolidone (PVP) with a molecular weight range of 2000 to 54,000 daltons. The invention further provides a method to minimize inflammation at the injection site during subcutaneous administration of a macromolecule. In further aspects, the invention provides pharmaceutical formulations for subcutaneous administration of a macromolecule, and methods of treating a CD20 positive cancer or an autoimmune disease, comprising administering a humanized anti-CD20 antibody in a pharmaceutical formulation of the invention. The invention further provides an in vitro dialysis method to evaluate the ability of an excipient to reduce aggregation of an antibody or other macromolecule under physiological conditions.