摘要:
The present invention provides improved methods for the manufacturing of IVIG products. These methods offer various advantages such as reduced loss of IgG during purification and improved quality of final products. In other aspects, the present invention provides aqueous and pharmaceutical compositions suitable for intravenous, subcutaneous, and/or intramuscular administration. In yet other embodiments, the present invention provides methods of treating a disease or condition comprising administration of an IgG composition provided herein.
摘要:
The present invention provides methods for providing a prognosis of treatment of diseases associated with inflammatory disease of the brain, including MS, e.g., relapsing-remitting multiple sclerosis (RRMS), Alzheimer's disease, and Parkinson's disease using molecular markers that are shown to be overexpressed or underexpressed in patients treated with intravenous immunoglobulins (IVIG). Also provided are methods to identify compounds that are useful for the treatment or prevention of MS, e.g., relapsing-remitting multiple sclerosis (RRMS), Alzheimer's disease, and Parkinson's disease.
摘要:
Provided herein are stable co-formulations of immunoglobulin and hyaluronidase that are stable to storage in liquid form at room temperature for at least 6 months and at standard refrigerator temperatures for 1-2 years. Such co-formulations can be used in methods of treating IG-treatable diseases or conditions by subcutaneous administration.
摘要:
The present invention provides methods for providing a prognosis of treatment of diseases associated with inflammatory disease of the brain, including MS, e.g., relapsing-remitting multiple sclerosis (RRMS), Alzheimer's disease, and Parkinson's disease using molecular markers that are shown to be overexpressed or underexpressed in patients treated with intravenous immunoglobulins (IVIG). Also provided are methods to identify compounds that are useful for the treatment or prevention of MS, e.g., relapsing-remitting multiple sclerosis (RRMS), Alzheimer's disease, and Parkinson's disease.
摘要:
The present invention provides novel methods for reducing the serine protease and/or serine protease zymogen content of a plasma-derived protein composition. Also provided are methods for manufacturing plasma-derived protein compositions having reduced serine protease and\or serine protease zymogen content. Among yet other aspects, the present invention provides aqueous and lyophilized compositions of plasma-derived proteins having reduced serine protease and/or serine protease zymogen content. Yet other aspects include methods for treating, managing, and/or preventing a disease comprising the administration of a plasma-derived protein composition having a reduced serine protease or serine protease zymogen content.
摘要:
The present invention relates to a new and improved method for preparing a highly concentrated immunoglobulin composition from pooled plasma for subcutaneous injection. A composition comprising 20% or more immunoglobulin suitable for subcutaneous use is also described.
摘要:
The present invention provides compositions and pharmaceutical formulations of Factor H derived from plasma. Also provided are methods for the manufacture of the Factor H compositions and formulations, as well as methods for the treatment of diseases associated with Factor H dysfunction.
摘要:
The present invention provides, among other aspects, storage stabile aqueous formulations of immunoglobulins with histidine at a mildly acidic to neutral pH. The present invention also provides methods for stabilizing immunoglobulin compositions by formulating with histidine at a mildly acidic to neutral pH. Advantageously, the methods and formulations provided herein allow stabile aqueous compositions of immunoglobulins at mildly acidic to neutral pH useful for parenteral administration.
摘要:
The present invention provides analytical methods for detecting anti-polymer antibody in an individual. The methods involve contacting a sample from the individual with a water soluble polymer-modified carrier and detecting binding of antibody to the water soluble polymer on the water soluble polymer-modified carrier wherein binding is indicative of the presence of antibody to the water polymer-modified polypeptide. Antibody may be detected to water soluble polymers such as polyethylene glycol, polysialic acid, dextran, hydroxyalkyl starch, or hydroxyethyl starch. When antibody to the water soluble polymer polyethylene glycol is to be detected, the carrier is modified with a non-linear polyethylene glycol derivative.