摘要:
Provided is a pharmaceutical composition involving a concentrated mixture of a precipitated protein and a liquid medium and a method for manufacturing the concentrated mixture. The concentrated mixture is manufacturable by precipitation of a protein with a biocompatible polymer precipitating agent, followed by removal of sufficient liquid to concentrate the resulting mixture to the desired degree. The precipitated protein can be stored for a significant time in the concentrated mixture, such as intermediate between processing stages during manufacture operations.
摘要:
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.
摘要:
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.
摘要:
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.
摘要:
A method is disclosed for preparing a transplantable tissue which has been cryopreserved with an intracellular cryoprotectant and then thawed. After thawing, the tissue is treated with a diluent (or eluent) solution to reduce the level of cryoprotectant in the cells to a substantially non-toxic level. This is conducted using a single dilution step. Cryoprotectants which are removable in this manner include dimethylsulfoxide, glycerol, propanediol and other compounds which penetrate the cells.The dilution step does not require end point titration and can be conducted over a time period greater than about 5 minutes.
摘要:
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.
摘要:
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.
摘要:
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 Clostridium botulinum neurotoxin protein and a glass-forming agent. These vaccine compositions are useful in the treatment of humans and other animals at risk of infection from Clostridium botulinum neurotoxin.
摘要:
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.
摘要:
A method of revitalizing cells or tissues that are to be cryopresserved for storage at ultracold temperatures, e.g. -196.degree. C. is disclosed which comprises preincubation of the cells or tissue from about 5 minutes to about 24 hours. The preincubation may be conducted at a temperature ranging from about 27.degree. C. to 42.degree. C., after which the tissue or cells are cryopreserved.