METHODS AND COMPOSITIONS COMPRISING PURIFIED RECOMBINANT PROTEINS

• Main Authors: SUSAN C FISHER, AILEN M SANCHEZ, MARTIN VANDERLAAN, ATIA NAIM, JOHN LOWE, CHRISTOPHER A TESKE, JAYME FRANKLIN, SALOUMEH KADKHODAYAN FISCHER, X CHRISTOPHER YU, CORAZON VICTA, ANNAMARIE AMURAO
• Format: Patent
• Language: English; Japanese
• Published: 17.10.2019
• Subjects: BEER; BIOCHEMISTRY; CHEMISTRY; ENZYMOLOGY; FERMENTATION OR ENZYME-USING PROCESSES TO SYNTHESISE A DESIREDCHEMICAL COMPOUND OR COMPOSITION OR TO SEPARATE OPTICAL ISOMERSFROM A RACEMIC MIXTURE; HUMAN NECESSITIES; HYGIENE; MEDICAL OR VETERINARY SCIENCE; METALLURGY; MICROBIOLOGY; MUTATION OR GENETIC ENGINEERING; ORGANIC CHEMISTRY; PEPTIDES; PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES; SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS ORMEDICINAL PREPARATIONS; SPIRITS; VINEGAR; WINE

To provide compositions comprising anti-IL13 monoclonal antibody preparations for treating IL13 mediated disorders and methods for producing the anti-IL13 antibody preparations.SOLUTION: Disclosed herein is a composition comprising an anti-IL13 monoclonal antibody purified from Chinese hamster ovary host cells by a process comprising Protein A affinity chromatography, anion exchange chromatography and hydrophobic interaction chromatography, where the composition comprises the anti-IL13 antibody and a residual amount of hamster PLBL2, and the amount of hamster PLBL2 is less than 20 ng/mg, or less than 15 ng/mg, or less than 10 ng/mg, or less than 8 ng/mg, or less than 5 ng/mg, or less than 3ng/mg, or less than 2 ng/mg, or less than 1 ng/mg, or less than 0.5 ng/mg.SELECTED DRAWING: Figure 3 【課題】ＩＬ１３媒介性障害を治療するための抗ＩＬ１３モノクローナル抗体調整物を含有する組成物、及び抗ＩＬ１３抗体調整物の製造方法の提供。【解決手段】チャイニーズハムスター卵巣宿主細胞から、プロテインＡアフィニティークロマトグラフィー工程と陰イオン交換クロマトグラフィー工程、疎水性相互作用クロマトグラフィー（ＨＩＣ）工程を含む工程により精製された抗ＩＬ１３モノクローナル抗体を含む組成物であって、抗ＩＬ１３抗体とハムスターＰＬＢＬ２の残量とを含み、ハムスターＰＬＢＬ２の量が、２０ｎｇ／ｍｇ未満、又は１５ｎｇ／ｍｇ未満、又は１０ｎｇ／ｍｇ未満、又は８ｎｇ／ｍｇ未満、又は５ｎｇ／ｍｇ未満、又は３ｎｇ／ｍｇ未満、又は２ｎｇ／ｍｇ未満、又は１ｎｇ／ｍｇ未満、又は０．５ｎｇ／ｍｇ未満である、組成物。【選択図】図３