JP-2022528310-A5 -

Dates

Publication Date

20221228

Application Date

20191216

Description

Reference 1: Lolas A. Microbial Control Strategies in Bioprocessing Falling Short of Assur-ing Product Quality and Satisfying Regulation Expectations. American Pharm. Rev. (2013); www. americanpharmaceuticalreview. com/Featured-Articles/134040-Microbial-Control-Strategies-in-Bioprocessing-Fal ling-Short-of-Assuring-Product-Quality-and-Satisfying-Regulation-Expectations. 2: Suvarna K, et al. Case Studies of Microbiological Contamination in Biological Product Manufacturing. American. Pharm. Rev. 14(1) 2011: 50-56. 3: Issekutz A. Removal of Gram-Negative Endotoxin from Solutions By Affinity Chromatography. J. Immunol. Met. 61(3) 1983: 275-281. 4: Anspach F. Endotoxin Removal By Affinity Sorbents. J. Biochem. Biophys. 449(1-3) 2001: 665-681. 5: Guo W, et al. Removal of Endotoxin from Aqueous By Affinity Membrane. Biomed. Chromatogr. 11(3) 1997: 164-166. 6: Chen H, et al. Factors Affecting Endotoxin Removal from Recombinant Therapeutic Proteins By Anion Exchange Chromatography. Prot. Expr. Purif. 64(1) 2009:76-81. 7: Hirayama C, et al. Cross-linked N,N Dimethylaminopropylacrylamide Spherical Particles for Selective Removal of Endotoxin. J. Chromatogr. A 676(2) 1994: 267-275. 8: Hoess A, Lidington R. Lipopolysaccharide-Binding and Neutralizing Peptides. World Patent WO 1995005393 A2 1993l; www. google. com/patents/ WO1995005393A2? cl=en:Method. 9: Kang Y. Endotoxin removal from protein solutions by immobilized metal affinity chromatography, 2000, archives. njit. edu/vol01/etd/2000s/2000/njit-etd2000-023/njit-etd2000-023. pdf. 10: Luo R, Kang Y. Methods for endotoxin removal from biological solutions using immobilized meta affinity, United States Patent US6365147B1, 1999. Exemplary embodiments of the present invention are described below. <1> A method for depleting or removing endotoxins from a known or suspected endotoxin-containing source by a solid-phase extraction material in an essentially aqueous system, - The step of providing a supply that is known to contain endotoxins or is suspected to contain endotoxins. - A step of contacting the feed, which is known to contain endotoxin or suspected to contain endotoxin, with a positively charged solid-phase material having a surface on which ferric is immobilized, wherein the solid-phase extract material is immobilized with (2-aminoethyl)amine (TREN) ligand. - A step of incubating the supply, which is known to contain endotoxins or is suspected to contain endotoxins, for a time sufficient to bind the endotoxins to the porous solid phase material. - The step of separating the solid phase material from the essentially aqueous system, A method that optionally includes the step of isolating the essentially aqueous system from which the endotoxin has been removed or depleted. <2> The method according to <1>, wherein the solid-phase extraction is a method selected from the group consisting of chromatography, filtration, coprecipitation, and combinations thereof. <3> The method according to <1> or <2>, wherein the solid phase material comprises a chromatographic material for depleting or removing endotoxins from the feed, which is known to contain endotoxins or is suspected to contain endotoxins, by ferric chelation. <4> The method according to any one of <1> to <3> for the production of a composition containing a low endotoxin bacteriophage, particularly for therapeutic purposes, such as the purification of recombinant-produced proteins, the removal of endotoxins and/or viruses from cell culture components used in the preparation of recombinant-produced proteins, and the removal of endotoxins from in vitro diagnostic assay reagents. <5> A method according to any one of <1> to <4>, which is carried out in combination with other purification methods. <6> The method according to <5>, wherein the other purification method is selected from hydrophobic interaction chromatography, preferential exclusion chromatography, and anion exchange chromatography. <7> A fraction obtained by the process of the present invention, which contains bacteriophages in an essentially aqueous system, with endotoxins removed or depleted, wherein the endotoxin concentration is less than 1 EU per 10⁹ infectious bacteriophage particles. <8> A kit comprising at least one component for carrying out the method described in any one of <1> to <6>. <9> The kit according to <8>, wherein the at least one component is at least one of the solid-phase extraction materials, the solid-phase extraction material has a positive charge and has ferric iron immobilized by a (2-aminoethyl)amine (TREN) ligand. <10> The kit according to <9>, wherein the solid-phase extraction material is in the form of granular material or monolith, fiber, fibrous material, one or more membranes, or a combination thereof. <11> A kit according to any one of <8> to <10>, including instructions for carrying out any one of the methods described in any one of <1> to <6>.