Abstract:
A process for the isolation of a protein from a natural source in sterile form for use as a pharmaceutical product, comprising the steps of: (1) providing a sterilised membrane whose pores are sufficiently small to exclude pathogens; (2) passing a protein solution derived from a natural source through the membrane in a sterile environment; and (3) collecting the sterile filtrate.
Abstract:
Ce matériau se présente sous la forme d'une pièce moulée, constituée d'un liant biocompatible contenant un ou plusieurs composés réalisant un apport de calcium et de phosphore, caractérisé par le fait qu'il a subi une opération de décapage surfacique destiné à assurer la mise en surface et donc l'accès en surface des éléments ajoutés au liant, notamment du calcium et du phosphore. Ce matériau peut avantageusement être utilisé pour la réalisation d'implants endo-osseux ou de prothèses osseuses.
Abstract:
The present invention relates to methods for terminal sterilization of solid forms of nanoparticulate active agent compositions via gamma irradiation. The nanoparticulate active agent has an effective average particle size of less than about 2 microns, prior to incorporation into a solid form for sterilization. The resultant sterilized compositions exhibit excellent redispersibility, homogeneity, and uniformity. Also encompassed are compositions made via the described method and methods of treating animals and humans using such compositions.
Abstract:
Methods are disclosed for sterilizing biological materials to reduce the level of one or more biological contaminants or pathogens therein, such as viruses, bacteria (including inter- and intracellular bacteria, such as mycoplasmas, ureaplasmas, nanobacteria, chlamydia, rickettsias), yeasts, molds, fungi, single or multicellular parasites, and/or prions or similar agents responsible, alone or in combination, for TSEs.
Abstract:
Methods are disclosed for sterilizing milk to reduce the level of active biological contaminants such as viruses, bacteria, yeasts, molds, mycoplasmas and parasites.
Abstract:
Methods are disclosed for sterilizing preparations of digestive enzymes to reduce the level of one or more active biological contaminants or pathogens therein, such as viruses, bacteria (including inter- and intracellular bacteria, such as mycoplasmas, ureaplasmas, nanobacteria, chlamydia, rickettsias), yeasts, molds, fungi, prions or similar agents responsible, alone or in combination, for TSEs and/or single or multicellular parasites. These methods involve sterilizing preparations of digestive enzymes, such as trypsin, -galactosidase and iduronate-2-sulfatase, with irradiation.
Abstract:
Methods of producing a terminally sterilized topical patch preparation are provided. In the subject methods, a topical patch preparation is exposed to electron beam radiation, preferably low level electron beam radiation, for a period of time sufficient to terminally sterilize the topical patch preparation. Also provided are the terminally sterilized topical patch preparations produced by the subject methods and methods of using the same.
Abstract:
The invention provides articles of manufacture and methods for preparing substantially non-immunogenic soft, and bone tissue xenografts for implantation into humans. The xenografts are prepared by removing at least a portion of a soft or bone tissue from a non-human animal to provide a xenograft; washing the xenograft in saline, and alcohol; subjecting the xenograft to cellular disruption treatment; exposing the xenograft to an aldehyde in an amount ranging from about 0.01 % to about 0.10 %; and digesting the xenograft with a glycosidase, and optionally following with a capping treatment. The invention further provides a soft or bone tissue xenograft for implantation into a human including a portion of a soft or bone tissue from a non-human animal, wherein the portion has extracellular components, and substantially only dead cells. The extracellular components have substantially no surface carbohydrate moieties which are susceptible to glycosidase digestion, and have an aldehyde in an amount ranging from about 0.01 % to about 0.10 % of crosslinking the proteins of the extracellular components. Each of the xenografts of the invention are substantially non-immunogenic, and have substantially the same mechanical properties as a corresponding native soft or bone tissue.
Abstract:
This invention pertains to methods of lyophilizing collagen-based biomaterials, which lyophilates, when reconstituted, retain hemostatic activity and can be extruded. This invention also pertains to methods of radiation-sterilization of lyophilized collagen-based biomaterials.
Abstract:
A material comprising a sterilized material and a sterile protective agent which comprises a polysaccharide made up of three or more monosaccharide molecules and having a positive charge.