JP2019530857A5 - - Google Patents

Download PDF

Info

Publication number
JP2019530857A5
JP2019530857A5 JP2019507829A JP2019507829A JP2019530857A5 JP 2019530857 A5 JP2019530857 A5 JP 2019530857A5 JP 2019507829 A JP2019507829 A JP 2019507829A JP 2019507829 A JP2019507829 A JP 2019507829A JP 2019530857 A5 JP2019530857 A5 JP 2019530857A5
Authority
JP
Japan
Prior art keywords
mobile phase
composition
chromatography
ratio
mixed mode
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
JP2019507829A
Other languages
English (en)
Japanese (ja)
Other versions
JP2019530857A (ja
JP7286536B2 (ja
Filing date
Publication date
Application filed filed Critical
Priority claimed from PCT/US2017/046725 external-priority patent/WO2018035025A1/en
Publication of JP2019530857A publication Critical patent/JP2019530857A/ja
Publication of JP2019530857A5 publication Critical patent/JP2019530857A5/ja
Application granted granted Critical
Publication of JP7286536B2 publication Critical patent/JP7286536B2/ja
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

JP2019507829A 2016-08-15 2017-08-14 非イオン性サーファクタント及びポリペプチドを含む組成物中の非イオン性サーファクタントを定量するためのクロマトグラフィー法 Active JP7286536B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201662375373P 2016-08-15 2016-08-15
US62/375,373 2016-08-15
PCT/US2017/046725 WO2018035025A1 (en) 2016-08-15 2017-08-14 Chromatography method for quantifying a non-ionic surfactant in a composition comprising the non-ionic surfactant and a polypeptide

Publications (3)

Publication Number Publication Date
JP2019530857A JP2019530857A (ja) 2019-10-24
JP2019530857A5 true JP2019530857A5 (https=) 2020-09-24
JP7286536B2 JP7286536B2 (ja) 2023-06-05

Family

ID=59687053

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2019507829A Active JP7286536B2 (ja) 2016-08-15 2017-08-14 非イオン性サーファクタント及びポリペプチドを含む組成物中の非イオン性サーファクタントを定量するためのクロマトグラフィー法

Country Status (17)

Country Link
US (2) US11333644B2 (https=)
EP (1) EP3497440B1 (https=)
JP (1) JP7286536B2 (https=)
KR (1) KR102617148B1 (https=)
CN (2) CN115598231B (https=)
AR (1) AR109343A1 (https=)
AU (2) AU2017312540B2 (https=)
BR (1) BR112019002979B1 (https=)
ES (1) ES3034020T3 (https=)
HR (1) HRP20250718T1 (https=)
HU (1) HUE071741T2 (https=)
IL (1) IL264582B (https=)
MX (2) MX2019001572A (https=)
PL (1) PL3497440T3 (https=)
SG (1) SG11201901228QA (https=)
TW (1) TWI775770B (https=)
WO (1) WO2018035025A1 (https=)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20210139387A1 (en) * 2016-01-19 2021-05-13 Genebiologics, Llc Production of Arginine-Rich Proteins from Wastewater and Use as a Fertilizer
HRP20250718T1 (hr) 2016-08-15 2025-08-15 F. Hoffmann-La Roche Ag Kromatografski postupak za kvantifikaciju neionskog surfaktanta u sastavu koji sadrži neionski surfaktant i polipeptid
TWI870390B (zh) * 2019-02-27 2025-01-21 法商賽諾菲公司 以具內標之lc-ms於樣品中進行聚山梨醇酯定量之方法
CN113424057B (zh) * 2019-04-19 2024-04-05 海正生物制药有限公司 组合物中泊洛沙姆188的检测方法
JP2022531317A (ja) 2019-05-03 2022-07-06 ジェネンテック， インコーポレイテッド 精製プラットフォームから得られた組成物中の酵素加水分解活性速度を低下させる方法
EP4090666A1 (en) 2020-01-15 2022-11-23 F. Hoffmann-La Roche AG Methods to decrease impurities from recombinant protein manufacturing processes
CA3198684A1 (en) 2020-10-30 2022-05-05 Genentech, Inc. Purification platforms for obtaining pharmaceutical compositions having a reduced hydrolytic enzyme activity rate
BR112023016996A2 (pt) 2021-02-24 2023-09-26 Hoffmann La Roche Métodos para purificar um polipeptídeo terapêutico e para produzir um polipeptídeo terapêutico e usos de uma solução ácida e de uma solução alcalina
KR102283871B1 (ko) * 2021-03-02 2021-08-02 한국원자력연구원 크로마토그래피를 이용한 무담체 홀뮴-166의 분리 방법, 분리 장치 및 이에 의하여 분리된 무담체 홀뮴-166
AU2022429920A1 (en) * 2021-12-31 2024-07-25 Kashiv Biosciences, Llc A process for separation and quantification of non-ionic surfactant
WO2024145244A1 (en) * 2022-12-30 2024-07-04 Eli Lilly And Company Methods for measuring levels of polysorbate(s)
WO2026062617A1 (en) * 2024-09-23 2026-03-26 Janssen Pharmaceuticals, Inc. Methods for detection and quantification of surfactants

Family Cites Families (52)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2413974A1 (fr) 1978-01-06 1979-08-03 David Bernard Sechoir pour feuilles imprimees par serigraphie
US4816567A (en) 1983-04-08 1989-03-28 Genentech, Inc. Recombinant immunoglobin preparations
JPS61141719A (ja) * 1984-08-22 1986-06-28 キュノ、インコ−ポレ−テッド 変性ポリペプチド支持体
US4676980A (en) 1985-09-23 1987-06-30 The United States Of America As Represented By The Secretary Of The Department Of Health And Human Services Target specific cross-linked heteroantibodies
US5567610A (en) 1986-09-04 1996-10-22 Bioinvent International Ab Method of producing human monoclonal antibodies and kit therefor
IL85035A0 (en) 1987-01-08 1988-06-30 Int Genetic Eng Polynucleotide molecule,a chimeric antibody with specificity for human b cell surface antigen,a process for the preparation and methods utilizing the same
DE3850542T2 (de) 1987-09-23 1994-11-24 Bristol Myers Squibb Co Antikörper-Heterokonjugate zur Töting von HIV-infizierten Zellen.
GB8823869D0 (en) 1988-10-12 1988-11-16 Medical Res Council Production of antibodies
US5175384A (en) 1988-12-05 1992-12-29 Genpharm International Transgenic mice depleted in mature t-cells and methods for making transgenic mice
DE3920358A1 (de) 1989-06-22 1991-01-17 Behringwerke Ag Bispezifische und oligospezifische, mono- und oligovalente antikoerperkonstrukte, ihre herstellung und verwendung
ES2096590T3 (es) 1989-06-29 1997-03-16 Medarex Inc Reactivos biespecificos para la terapia del sida.
US5208020A (en) 1989-10-25 1993-05-04 Immunogen Inc. Cytotoxic agents comprising maytansinoids and their therapeutic use
US5229275A (en) 1990-04-26 1993-07-20 Akzo N.V. In-vitro method for producing antigen-specific human monoclonal antibodies
US5571894A (en) 1991-02-05 1996-11-05 Ciba-Geigy Corporation Recombinant antibodies specific for a growth factor receptor
WO1992020373A1 (en) 1991-05-14 1992-11-26 Repligen Corporation Heteroconjugate antibodies for treatment of hiv infection
EP1400536A1 (en) 1991-06-14 2004-03-24 Genentech Inc. Method for making humanized antibodies
MX9204374A (es) 1991-07-25 1993-03-01 Idec Pharma Corp Anticuerpo recombinante y metodo para su produccion.
US7018809B1 (en) 1991-09-19 2006-03-28 Genentech, Inc. Expression of functional antibody fragments
US5565332A (en) 1991-09-23 1996-10-15 Medical Research Council Production of chimeric antibodies - a combinatorial approach
FI941572A7 (fi) 1991-10-07 1994-05-27 Oncologix Inc Anti-erbB-2-monoklonaalisten vasta-aineiden yhdistelmä ja käyttömenete lmä
WO1993008829A1 (en) 1991-11-04 1993-05-13 The Regents Of The University Of California Compositions that mediate killing of hiv-infected cells
ATE207080T1 (de) 1991-11-25 2001-11-15 Enzon Inc Multivalente antigen-bindende proteine
CA2372813A1 (en) 1992-02-06 1993-08-19 L.L. Houston Biosynthetic binding protein for cancer marker
WO1993016177A1 (en) 1992-02-11 1993-08-19 Cell Genesys, Inc. Homogenotization of gene-targeting events
US5573905A (en) 1992-03-30 1996-11-12 The Scripps Research Institute Encoded combinatorial chemical libraries
CA2140280A1 (en) 1992-08-17 1994-03-03 Avi J. Ashkenazi Bispecific immunoadhesins
DK0752248T3 (da) 1992-11-13 2000-11-13 Idec Pharma Corp Terapeutisk anvendelse af kimæriske og radioaktivt mærkede antistoffer mod humant B-lymfocytbegrænset differentieringsantig
US5534615A (en) 1994-04-25 1996-07-09 Genentech, Inc. Cardiac hypertrophy factor and uses therefor
US5789199A (en) 1994-11-03 1998-08-04 Genentech, Inc. Process for bacterial production of polypeptides
US5840523A (en) 1995-03-01 1998-11-24 Genetech, Inc. Methods and compositions for secretion of heterologous polypeptides
US5731168A (en) 1995-03-01 1998-03-24 Genentech, Inc. Method for making heteromultimeric polypeptides
US5641870A (en) 1995-04-20 1997-06-24 Genentech, Inc. Low pH hydrophobic interaction chromatography for antibody purification
US5712374A (en) 1995-06-07 1998-01-27 American Cyanamid Company Method for the preparation of substantiallly monomeric calicheamicin derivative/carrier conjugates
JPH0943218A (ja) * 1995-08-04 1997-02-14 Kao Corp 非イオン界面活性剤の分析方法
WO1999050655A1 (en) * 1998-03-30 1999-10-07 Cell Therapeutics, Inc. Methods of separation and detection
IL127127A0 (en) 1998-11-18 1999-09-22 Peptor Ltd Small functional units of antibody heavy chain variable regions
US8372954B2 (en) 2000-12-22 2013-02-12 National Research Council Of Canada Phage display libraries of human VH fragments
JP2005289809A (ja) 2001-10-24 2005-10-20 Vlaams Interuniversitair Inst Voor Biotechnologie Vzw (Vib Vzw) 突然変異重鎖抗体
GB0310347D0 (en) * 2003-05-07 2003-06-11 Delta Biotechnology Ltd Assay
DE602004017726D1 (de) 2003-06-30 2008-12-24 Domantis Ltd Pegylierte Single-domain-antikörper (dAb)
AU2005285347A1 (en) 2004-08-19 2006-03-23 Genentech, Inc. Polypeptide variants with altered effector function
DK1791565T3 (en) 2004-09-23 2016-08-01 Genentech Inc Cysteingensplejsede antibodies and conjugates
EP1833877A2 (en) * 2004-12-21 2007-09-19 Baxter International Inc. (polyalkoxy)sulfonate surface modifiers
US7241586B2 (en) * 2005-02-17 2007-07-10 Medtronic Minimed, Inc. Polypeptide formulations and methods for making, using and characterizing them
WO2010141426A1 (en) 2009-06-01 2010-12-09 Waters Technologies Corporation Hybrid material for chromatographic separations
US20120294866A1 (en) * 2010-01-19 2012-11-22 F. Hoffmann-La Roche Ag Pharmaceutical formulation for proteins
KR101976853B1 (ko) 2010-05-25 2019-05-09 제넨테크, 인크. 폴리펩티드의 정제 방법
JP5193266B2 (ja) 2010-11-16 2013-05-08 株式会社ミノファーゲン製薬 生薬由来成分の高感度定量方法
SG10201606218WA (en) * 2011-07-29 2016-09-29 Eleven Biotherapeutics Inc Purified Proteins
HUE035685T2 (en) * 2011-11-02 2018-05-28 Hoffmann La Roche Overload and elute chromatography
JP6129302B2 (ja) * 2012-05-23 2017-05-17 グラクソスミスクライン バイオロジカルズ ソシエテ アノニム 混合物中のポリソルベート種の濃度を決定するための方法
HRP20250718T1 (hr) 2016-08-15 2025-08-15 F. Hoffmann-La Roche Ag Kromatografski postupak za kvantifikaciju neionskog surfaktanta u sastavu koji sadrži neionski surfaktant i polipeptid

Similar Documents

Publication Publication Date Title
JP2019530857A5 (https=)
HRP20250718T1 (hr) Kromatografski postupak za kvantifikaciju neionskog surfaktanta u sastavu koji sadrži neionski surfaktant i polipeptid
Stoll et al. Characterization of therapeutic antibodies and related products by two-dimensional liquid chromatography coupled with UV absorbance and mass spectrometric detection
Qu et al. Qualitative and quantitative characterization of protein biotherapeutics with liquid chromatography mass spectrometry
Sarrut et al. Analysis of antibody-drug conjugates by comprehensive on-line two-dimensional hydrophobic interaction chromatography x reversed phase liquid chromatography hyphenated to high resolution mass spectrometry. I− Optimization of separation conditions
Venkatesh et al. Simultaneous estimation of six anti‐diabetic drugs—glibenclamide, gliclazide, glipizide, pioglitazone, repaglinide and rosiglitazone: development of a novel HPLC method for use in the analysis of pharmaceutical formulations and its application to human plasma assay
Hewitt et al. Quantitation of polysorbate 20 in protein solutions using mixed-mode chromatography and evaporative light scattering detection
Cardoso et al. Chiral method development strategies for HPLC using macrocyclic glycopeptide-based stationary phases
Suedee et al. Direct enantioseparation of adrenergic drugs via thin-layer chromatography using molecularly imprinted polymers
TW200942259A (en) High concentration antibody-containing liquid formulation
CN105722532A (zh) 包含纯化的重组多肽的方法和组合物
Martinez et al. Micellar liquid chromatography: a worthy technique for the determination of β-antagonists in urine samples
McCalley A study of the analysis of acidic solutes by hydrophilic interaction chromatography
Hebbi et al. High performance liquid chromatography (HPLC) based direct and simultaneous estimation of excipients in biopharmaceutical products
Patel et al. Simultaneous RP-HPLC estimation of moxifloxacin hydrochloride and ketorolac tromethamine in ophthalmic dosage forms
Zegota et al. High throughput multidimensional liquid chromatography approach for online protein removal and characterization of polysorbates and poloxamer in monoclonal antibody formulations
Long et al. A novel two-dimensional liquid chromatography-Mass spectrometry method for direct drug impurity identification from HPLC eluent containing ion-pairing reagent in mobile phases
El-Shoubashy et al. Comparative study of HPLC-DAD and HPTLC for the simultaneous determination of a new multitarget antidiabetic ternary mixture in combined tablets
JP7755766B2 (ja) 抗ｉｌ－６抗体製剤
Vaidya et al. Simultaneous RP HPLC determination of aceclofenac, paracetamol and tizanidine in pharmaceutical preparations
Liu et al. Separation of deamidated peptides with mixed-mode chromatography using phospholipid-functionalized monolithic stationary phases
Locatelli et al. High performance liquid chromatography determination of prulifloxacin and five related impurities in pharmaceutical formulations
JP2015206740A (ja) タンパク質に対する親和性評価のための分析方法及びその装置
Saita et al. Preparation of antibodies and development of an enzyme-linked immunosorbent assay for the tyrosine kinase inhibitors lapatinib and nilotinib
Vishnuvardhan et al. Study of forced degradation behaviour of brinzolamide using LC–ESI–Q-TOF and In silico toxicity prediction