Patent application number | Description | Published |
20090185996 | HYDROXYETHYL STARCH-CONTAINING POLYPEPTIDE COMPOSITIONS - The invention provides compositions containing hydroxyethyl starch and polypeptides, including therapeutic polypeptides such as interleukin-11, that provide for enhanced stability of the polypeptide following storage at room temperature or elevated temperatures. | 07-23-2009 |
20090298743 | HYDROPHOBIC COMPOSITIONS CONTAINING RECONSTITUTION ENHANCER - Disclosed are compositions comprising a hydrophobic active agent, a polymer and a reconstitution enhancing agent. Reconstitution of the lyophilized form of the compositions takes less time than in the absence of the enhancing agent. | 12-03-2009 |
20100129379 | STABILIZED ANTIBODY FORMULATIONS AND USES THEREOF - The present invention provides methods of optimizing certain stable liquid formulations of antibodies that immunospecifically bind to antigens of interest. Such formulations are suitable for parenteral administration to a subject, and exhibit increased stability, low to undetectable levels of aggregation, low to undetectable levels of antibody fragmentation/degradation, and very little to no loss of the biological activities of the antibodies, even during long periods of storage. The methods of the invention provide formulations that offer multiple advantages over formulations produced by non-optimized methods, including less stringent or more readily available transportation and storage conditions, less frequent dosing, and/or smaller dosage amounts in the therapeutic, prophylactic and diagnostic uses of such formulations. The invention further provides methods of identifying antibodies exhibiting certain phase behaviors such that the antibodies can be formulated by the methods of the invention. Also provided are prophylactic, therapeutic, and diagnostic uses of such antibody formulations. | 05-27-2010 |
20110091415 | Hydroxyethyl Starch-Containing Polypeptide Compositions - The invention provides compositions containing hydroxyethyl starch and polypeptides, including therapeutic polypeptides such as interleukin-11, that provide for enhanced stability of the polypeptide following storage at room temperature or elevated temperatures. | 04-21-2011 |
20120083446 | NOVEL ALBUMIN-FREE FACTOR VIII FORMULATIONS - An albumin-free Factor VIII formulation comprising, 4% to 10% of a bulking agent selected from the group consisting of mannitol, glycine and alanine; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; 100 mM to 300 mM NaCl; and a buffering agent Alternatively, the formulation can comprise 2% to 6% hydroxyethyl starch; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; 100 mM to 300 mM NaCl; and a buffering agent. In a further embodiment, the formulation can comprise: 300 mM to 500 mM NaCl; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; and a buffering agent. | 04-05-2012 |
20120134958 | HYDROXYETHYL STARCH-CONTAINING POLYPEPTIDE COMPOSITIONS - The invention provides compositions containing hydroxyethyl starch and polypeptides, including therapeutic polypeptides such as interleukin-11, that provide for enhanced stability of the polypeptide following storage at room temperature or elevated temperatures. | 05-31-2012 |
20130184216 | NOVEL ALBUMIN-FREE FACTOR VIII FORMULATIONS - A Factor VIII composition formulated without albumin, comprising the following formulation excipients in addition to Factor VIII: 4% to 10% of a bulking agent selected from the group consisting of mannitol, glycine and alanine; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; 100 mM to 300 mM NaCl; and a buffering agent for maintaining a pH of approximately between 6 and 8. Alternatively, the formulation can comprise 2% to 6% hydroxyethyl starch; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; 100 mM to 300 mM NaCl; and a buffering agent for maintaining a pH of approximately between 6 and 8. In a further embodiment, the formulation can comprise: 300 mM to 500 mM NaCl; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; and a buffering agent. | 07-18-2013 |
20130309273 | Thermostable Vaccine Compositions and Methods of Preparing Same - The disclosure provides compositions relating to thermostable vaccines and methods of preparing same. Specifically, the disclosure provides for methods of preparing thermostable vaccines based on a recombinant ricin neurotoxin protein and uses of co-adjuvants to develop a composition capable of eliciting an immune response in a subject. | 11-21-2013 |
20150025010 | NOVEL ALBUMIN-FREE FACTOR VIII FORMULATIONS - A Factor VIII composition formulated without albumin, comprising the following formulation excipients in addition to Factor VIII: 4% to 10% of a bulking agent selected from the group consisting of mannitol, glycine and alanine; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; 100 mM to 300 mM NaCl; and a buffering agent for maintaining a pH of approximately between 6 and 8. Alternatively, the formulation can comprise 2% to 6% hydroxyethyl starch; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; 100 mM to 300 mM NaCl; and a buffering agent for maintaining a pH of approximately between 6 and 8. In a further embodiment, the formulation can comprise: 300 mM to 500 mM NaCl; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; and a buffering agent. | 01-22-2015 |
Patent application number | Description | Published |
20080248522 | HIGH-PRESSURE INCLUSION BODY SOLUBILIZATION AND PROTEASE CLIPPING OF RECOMBINANT FUSION PROTEINS - Described herein are methods for the solubilization and proteolytic cleavage of fusion protein aggregates, including autocatalytic fusion proteins, at pressures greater than atmospheric pressure to yield soluble target polypeptides. | 10-09-2008 |
20080249286 | HIGH-PRESSURE REFOLDING OF PROTEINS IN THE PRESENCE OF BINDING PARTNERS - Methods for producing biologically active protein from aggregated and/or denatured proteins which comprise subjecting the protein to high hydrostatic pressure in the presence of a ligand or specific binding agent are disclosed. The ligand can be a macromolecule, such as another protein, a nucleic acid, or other macromolecules, or the ligand can be a small organic molecule. | 10-09-2008 |
20100075399 | METHODS FOR PROTEIN REFOLDING - The present invention discloses improved methods of disaggregating protein aggregates, and refolding denatured proteins, using high pressure. In particular, the present invention provides for the use of agitation, high temperature, “stepped” depressurization, dialysis and dilution under pressure to increase the speed and extent of aggregate dissolution and protein refolding. | 03-25-2010 |
20100158951 | Method of Preparing an Immunologically-Active Adjuvant-Bound Dried Vaccine Composition - The disclosure provides a method of preparing an immunologically-active adjuvant-bound freeze dried vaccine composition. A specific embodiment provides a stable vaccine composition comprising an aluminum-salt adjuvant, a recombinant | 06-24-2010 |
20100255536 | HIGH PRESSURE REFOLDING OF PROTEIN AGGREGATES AND INCLUSION BODIES - The present disclosure provides an effective method for the refolding of denatured proteins in solution so that properly folded, biologically active protein in solution is recovered in high yield. The refolding takes place at pressures between about 0.25 kbar to about 3.5 kbar, advantageously at about 1.5 kbar to about 3 kbar. Typically a chaotropic agent is present at a concentration which is not effective for denaturing protein at atmospheric pressure, and optionally, oxidation-reduction reagents can be incorporated in the refolding solution so that native intramolecular disulfide bonds can be formed where that is desired. The method is applicable to substantially all proteins, especially after solubilization and/or denaturation of insoluble protein aggregates, inclusion bodies, or abnormal oligomeric (soluble) aggregates. | 10-07-2010 |
20100330162 | Spray freeze dry of compositions for pulmonary adminstration - This invention provides methods and compositions to preserve bioactive materials, such as viruses, bacteria, cells, or liposomes, in freeze dried particles suitable for pulmonary administration. Methods provide spray freeze drying of formulations to form stable freeze dried particles. | 12-30-2010 |
20110046357 | HIGH PRESSURE REFOLDING OF PROTEIN AGGREGATES AND INCLUSION BODIES - The present disclosure provides an effective method for the refolding of denatured proteins in solution so that properly folded, biologically active protein in solution is recovered in high yield. The refolding takes place at pressures between about 0.25 kbar to about 3.5 kbar, advantageously at about 1.5 kbar to about 3 kbar. Typically a chaotropic agent is present at a concentration which is not effective for denaturing protein at atmospheric pressure, and optionally, oxidation-reduction reagents can be incorporated in the refolding solution so that native intramolecular disulfide bonds can be formed where that is desired. The method is applicable to substantially all proteins, especially after solubilization and/or denaturation of insoluble protein aggregates, inclusion bodies, or abnormal oligomeric (soluble) aggregates. | 02-24-2011 |
20110243996 | Spray freeze dry of compositions for intranasal administration - This invention provides methods and compositions to preserve bioactive materials, such as peptides, nucleic acids, viruses, bacteria, cells, or liposomes, in freeze dried particles suitable for intranasal administration. Methods provide spray freeze drying of formulations to form stable freeze dried particles for intranasal administration. | 10-06-2011 |
20120046225 | STABLE GLUCAGON FORMULATIONS FOR THE TREATMENT OF HYPOGLYCEMIA - The delivery of biopharmaceutical and other therapeutic agents parenterally to an animal via a minimally invasive, low pain administration is provided. The agents are delivered to the patient via, e.g., the epidermal, dermal, or subcutaneous layer of the skin in a concentrated form of injectable glucagon that is dissolved in a pharmaceutically acceptable carrier. | 02-23-2012 |
20130315966 | Method of Preparing an Immunologically-Active Adjuvant-Bound Dried Vaccine Composition - The disclosure provides a method of preparing an immunologically-active adjuvant-bound freeze dried vaccine composition. A specific embodiment provides a stable vaccine composition comprising an aluminum-salt adjuvant, a recombinant | 11-28-2013 |
20140171364 | STABLE GLUCAGON FORMULATIONS FOR THE TREATMENT OF HYPOGLYCEMIA - The delivery of biopharmaceutical and other therapeutic agents parenterally to an animal via a minimally invasive, low pain administration is provided. The agents are delivered to the patient via, e.g., the epidermal, dermal, or subcutaneous layer of the skin in a concentrated form of injectable glucagon that is dissolved in a pharmaceutically acceptable carrier. | 06-19-2014 |