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HRP20250718T1 - Kromatografski postupak za kvantifikaciju neionskog surfaktanta u sastavu koji sadrži neionski surfaktant i polipeptid - Google Patents

Kromatografski postupak za kvantifikaciju neionskog surfaktanta u sastavu koji sadrži neionski surfaktant i polipeptid

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Publication number
HRP20250718T1
HRP20250718T1 HRP20250718TT HRP20250718T HRP20250718T1 HR P20250718 T1 HRP20250718 T1 HR P20250718T1 HR P20250718T T HRP20250718T T HR P20250718TT HR P20250718 T HRP20250718 T HR P20250718T HR P20250718 T1 HRP20250718 T1 HR P20250718T1
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HR
Croatia
Prior art keywords
mobile phase
polypeptide
process according
nonionic surfactant
composition
Prior art date
Application number
HRP20250718TT
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English (en)
Inventor
Mary MONTTI
Richard. L. Beardsley
Michael S. CHINN
Original Assignee
F. Hoffmann-La Roche Ag
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by F. Hoffmann-La Roche Ag filed Critical F. Hoffmann-La Roche Ag
Publication of HRP20250718T1 publication Critical patent/HRP20250718T1/hr

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02—Column chromatography
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/96—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation using ion-exchange
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08—Selective adsorption, e.g. chromatography
    • B01D15/26—Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/36—Selective adsorption, e.g. chromatography characterised by the separation mechanism involving ionic interaction, e.g. ion-exchange, ion-pair, ion-suppression or ion-exclusion
    • B01D15/361—Ion-exchange
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08—Selective adsorption, e.g. chromatography
    • B01D15/26—Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/38—Selective adsorption, e.g. chromatography characterised by the separation mechanism involving specific interaction not covered by one or more of groups B01D15/265 and B01D15/30 - B01D15/36, e.g. affinity, ligand exchange or chiral chromatography
    • B01D15/3847—Multimodal interactions
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02—Column chromatography
    • G01N30/26—Conditioning of the fluid carrier; Flow patterns
    • G01N30/28—Control of physical parameters of the fluid carrier
    • G01N30/34—Control of physical parameters of the fluid carrier of fluid composition, e.g. gradient
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02—Column chromatography
    • G01N30/26—Conditioning of the fluid carrier; Flow patterns
    • G01N30/28—Control of physical parameters of the fluid carrier
    • G01N30/36—Control of physical parameters of the fluid carrier in high pressure liquid systems
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02—Column chromatography
    • G01N30/62—Detectors specially adapted therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin

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  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Biochemistry (AREA)
  • Physics & Mathematics (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Molecular Biology (AREA)
  • Peptides Or Proteins (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Other Investigation Or Analysis Of Materials By Electrical Means (AREA)
  • Medicinal Preparation (AREA)

Claims (26)

1. Postupak, naznačen time, da je za kvantifikaciju neionskog surfaktanta u sastavu koji sadrži neionski surfaktant i polipeptid, pri čemu je tijekom kvantifikacije smanjena interferencija između neionskog surfaktanta i polipeptida, te pri čemu postupak obuhvaća sljedeće korake a) nanošenje sastava na kromatografski materijal za anionsku izmjenu miješanog načina rada, pri čemu se sastav puni na kromatografski materijal u otopini koja sadrži mobilnu fazu A i mobilnu fazu B, pri čemu mobilna faza A sadrži kiselinu u vodi, a mobilna faza B sadrži kiselinu u metanolu, pri čemu se polipeptid veže na kromatografski materijal specifično i nespecifično; b) eluiranje specifično vezanog polipeptida iz materijala za izmjenu aniona u miješanom načinu rada s otopinom koja sadrži mobilnu fazu A i mobilnu fazu B, pri čemu je omjer mobilne faze B prema mobilnoj fazi A povećan u usporedbi s korakom a); c) eluiranje neionskog surfaktanta i nespecifično vezanog polipeptida iz kromatografskog materijala s otopinom koja sadrži mobilnu fazu A i mobilnu fazu B, pri čemu je omjer mobilne faze B prema mobilnoj fazi A povećan u usporedbi s korakom b); d) kvantificiranje neionskog surfaktanta, pri čemu je interferencija između neionskog surfaktanta i polipeptida tijekom kvantificiranja smanjena; i time, da je neionski surfaktant polisorbat 20 ili polisorbat 80.
2. Postupak prema patentnom zahtjevu 1, naznačen time, da je omjer mobilne faze B prema mobilnoj fazi A u koraku a) oko 10:90.
3. Postupak prema patentnom zahtjevu 1 ili 2, naznačen time, da se omjer mobilne faze B prema mobilnoj fazi A povećava na oko 40:60 u koraku b).
4. Postupak prema bilo kojem od patentnih zahtjeva 1-3, naznačen time, da se omjer mobilne faze B prema mobilnoj fazi A povećava na oko 100:0 u koraku c).
5. Postupak prema bilo kojem od patentnih zahtjeva 1-4, naznačen time, da mobilna faza A sadrži oko 2% kiseline u vodi.
6. Postupak prema bilo kojem od patentnih zahtjeva 1-5, naznačen time, da mobilna faza B sadrži oko 2% kiseline u metanolu.
7. Postupak prema bilo kojem od patentnih zahtjeva 1-6, naznačen time, da je kiselina mravlja kiselina.
8. Postupak prema bilo kojem od patentnih zahtjeva 1-6, naznačen time, da je kiselina octena kiselina.
9. Postupak prema bilo kojem od patentnih zahtjeva 1-8, naznačen time, da je brzina protoka kromatografije oko 1,25 ml/min.
10. Postupak prema bilo kojem od patentnih zahtjeva 1-9, naznačen time, da je koncentracija neionskog surfaktanta u sastavu u rasponu od oko 0,001% do 1,0% (m/v).
11. Postupak prema bilo kojem od patentnih zahtjeva 1-10, naznačen time, da je polipeptid terapijski polipeptid.
12. Postupak prema bilo kojem od patentnih zahtjeva 1-11, naznačen time, da materijal za kromatografiju s izmjenom aniona miješanog načina rada sadrži polimer s reverznom fazom i jakom anionskom izmjenom.
13. Postupak za kvantificiranje neionskog surfaktanta u sastavu koji sadrži neionski surfaktant i polipeptid, naznačen time, da postupak obuhvaća sljedeće korake a) nanošenje sastava na kromatografski materijal za kationsku izmjenu miješanog načina rada, pri čemu se sastav puni na kromatografski materijal u otopini koja sadrži mobilnu fazu A i mobilnu fazu B, pri čemu mobilna faza A sadrži amonijev hidroksid u vodi, a mobilna faza B sadrži amonijev hidroksid u organskom otapalu; b) eluiranje polipeptida iz materijala za izmjenu kationa u miješanom načinu rada s otopinom koja sadrži mobilnu fazu A i mobilnu fazu B, pri čemu je omjer mobilne faze B prema mobilnoj fazi A povećan u usporedbi s korakom a); c) eluiranje neionskog surfaktanta iz kromatografskog materijala s otopinom koja sadrži mobilnu fazu A i mobilnu fazu B, pri čemu je omjer mobilne faze B prema mobilnoj fazi A povećan u usporedbi s korakom b); d) kvantificiranje neionskog surfaktanta; i time, da je neionski surfaktant polisorbat 20 ili polisorbat 80.
14. Postupak prema patentnom zahtjevu 13, naznačen time, da je organsko otapalo mobilne faze B metanol.
15. Postupak prema patentnom zahtjevu 13 ili 14, naznačen time, da je omjer mobilne faze B prema mobilnoj fazi A u koraku a) oko 10:90.
16. Postupak prema bilo kojem od patentnih zahtjeva 13-15, naznačen time, da se omjer mobilne faze B prema mobilnoj fazi A povećava na oko 45:55 u koraku b).
17. Postupak prema bilo kojem od patentnih zahtjeva 13-16, naznačen time, da se omjer mobilne faze B prema mobilnoj fazi A povećava na oko 100:0 u koraku c).
18. Postupak prema bilo kojem od patentnih zahtjeva 13-17, naznačen time, da mobilna faza A sadrži oko 2% amonijevog hidroksida u vodi.
19. Postupak prema bilo kojem od patentnih zahtjeva 13-18, naznačen time, da mobilna faza B sadrži oko 2% amonijevog hidroksida u metanolu.
20. Postupak prema bilo kojem od patentnih zahtjeva 13-19, naznačen time, da je brzina protoka kromatografije oko 1,4 ml/min.
21. Postupak prema patentnim zahtjevima 13-20, naznačen time, da je koncentracija polisorbata u sastavu u rasponu od oko 0,001% do 1,0% (m/v).
22. Postupak prema bilo kojem od patentnih zahtjeva 13-21, naznačen time, da sastav dodatno sadrži N-acetil triptofan i/ili metionin.
23. Postupak prema bilo kojem od patentnih zahtjeva 13-22, naznačen time, da sastav predstavlja farmaceutsku formulaciju koja je pogodna za primjenu na pojedincu.
24. Postupak prema bilo kojem od patentnih zahtjeva 13-23, naznačen time, da je polipeptid terapijski polipeptid.
25. Postupak prema patentnom zahtjevu 24, naznačen time, da je terapijski polipeptid fuzijski protein, poliklonsko protutijelo, monoklonsko protutijelo, humanizirano protutijelo, ljudsko protutijelo, kimerno protutijelo, multispecifično protutijelo, glikokonstruirano protutijelo, fragment protutijela, konjugat protutijela i lijeka.
26. Postupak prema bilo kojem od patentnih zahtjeva 13-25, naznačen time, da materijal za kromatografiju s izmjenom kationa miješanim načinom rada sadrži polimer s reverznom fazom i jakom kationskom izmjenom.
HRP20250718TT 2016-08-15 2017-08-14 Kromatografski postupak za kvantifikaciju neionskog surfaktanta u sastavu koji sadrži neionski surfaktant i polipeptid HRP20250718T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201662375373P 2016-08-15 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
EP17755627.1A EP3497440B1 (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

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US (2) US11333644B2 (hr)
EP (1) EP3497440B1 (hr)
JP (1) JP7286536B2 (hr)
KR (1) KR102617148B1 (hr)
CN (2) CN115598231A (hr)
AR (1) AR109343A1 (hr)
AU (2) AU2017312540B2 (hr)
BR (1) BR112019002979B1 (hr)
CA (1) CA3033737A1 (hr)
ES (1) ES3034020T3 (hr)
HR (1) HRP20250718T1 (hr)
HU (1) HUE071741T2 (hr)
IL (1) IL264582B (hr)
MX (2) MX2019001572A (hr)
PL (1) PL3497440T3 (hr)
SG (1) SG11201901228QA (hr)
TW (1) TWI775770B (hr)
WO (1) WO2018035025A1 (hr)

Families Citing this family (10)

* 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
WO2020211584A1 (zh) * 2019-04-19 2020-10-22 海正生物制药有限公司 组合物中泊洛沙姆188的检测方法
CN114981286A (zh) 2019-05-03 2022-08-30 豪夫迈·罗氏有限公司 降低从纯化平台获得的组合物中酶水解活性速率的方法
TW202233644A (zh) 2020-10-30 2022-09-01 美商建南德克公司 用於獲得水解酵素活性率降低的醫藥組成物之純化平台
CA3211070A1 (en) 2021-02-24 2022-09-01 F. Hoffmann-La Roche Ag Regeneration and multiple use of depth filters
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
EP4419229A2 (en) * 2021-12-31 2024-08-28 Kashiv Biosciences, LLC A process for separation and quantification of non-ionic surfactant
CN120712475A (zh) * 2022-12-30 2025-09-26 伊莱利利公司 测量聚山梨醇酯水平的方法

Family Cites Families (53)

* 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
ATE108068T1 (de) 1987-09-23 1994-07-15 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
ATE144793T1 (de) 1989-06-29 1996-11-15 Medarex Inc Bispezifische reagenzien für die aids-therapie
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
JPH06507398A (ja) 1991-05-14 1994-08-25 リプリジェン　コーポレーション Ｈｉｖ感染治療のための異種複合抗体
US6407213B1 (en) 1991-06-14 2002-06-18 Genentech, Inc. Method for making humanized antibodies
IE922437A1 (en) 1991-07-25 1993-01-27 Idec Pharma Corp Recombinant antibodies for human therapy
EP0604580A1 (en) 1991-09-19 1994-07-06 Genentech, Inc. EXPRESSION IN E. COLI OF ANTIBODY FRAGMENTS HAVING AT LEAST A CYSTEINE PRESENT AS A FREE THIOL, USE FOR THE PRODUCTION OF BIFUNCTIONAL F(ab') 2? ANTIBODIES
ES2136092T3 (es) 1991-09-23 1999-11-16 Medical Res Council Procedimientos para la produccion de anticuerpos humanizados.
FI941572L (fi) 1991-10-07 1994-05-27 Oncologix Inc Anti-erbB-2-monoklonaalisten vasta-aineiden yhdistelmä ja käyttömenetelmä
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
EP0625200B1 (en) 1992-02-06 2005-05-11 Chiron Corporation Biosynthetic binding protein for cancer marker
DE69333082T2 (de) 1992-02-11 2004-05-06 Cell Genesys, Inc., Foster City Erzielen von homozygotem durch zielgerichtete genetische ereignisse
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
EP0752248B1 (en) 1992-11-13 2000-09-27 Idec Pharmaceuticals Corporation Therapeutic application of chimeric and radiolabeled antibodies to human B lymphocyte restricted differentiation antigen for treatment of B cell lymphoma
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
US5731168A (en) 1995-03-01 1998-03-24 Genentech, Inc. Method for making heteromultimeric polypeptides
US5840523A (en) 1995-03-01 1998-11-24 Genetech, Inc. Methods and compositions for secretion of heterologous 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
AU3454899A (en) * 1998-03-30 1999-10-18 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
ES2376454T3 (es) 2000-12-22 2012-03-14 Grad, Carole, Legal Representative Of Howard, Kaplan Librer�?as de expresión en fago de fragmentos vh humanos.
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
ES2315664T3 (es) 2003-06-30 2009-04-01 Domantis Limited Anticuerpos de dominio unico (dab) pegilados.
EP1705482B1 (en) 2003-12-11 2017-09-27 Kazuhiro Imai Method of detection, separation and identification for expressed trace protein/peptide
ZA200701715B (en) 2004-08-19 2008-07-30 Genentech Inc Polypeptide variants with altered effector function
WO2006034488A2 (en) 2004-09-23 2006-03-30 Genentech, Inc. Cysteine engineered antibodies and conjugates
JP2008524393A (ja) * 2004-12-21 2008-07-10 バクスター・インターナショナル・インコーポレイテッド ポリアルコキシスルホネート表面改変因子
US7241586B2 (en) * 2005-02-17 2007-07-10 Medtronic Minimed, Inc. Polypeptide formulations and methods for making, using and characterizing them
EP2437882A4 (en) * 2009-06-01 2016-11-23 Waters Technologies Corp HYBRID MATERIAL FOR CHROMATOGRAPHY SEPARATIONS
US20120294866A1 (en) * 2010-01-19 2012-11-22 F. Hoffmann-La Roche Ag Pharmaceutical formulation for proteins
CA2799915C (en) * 2010-05-25 2023-09-26 Genentech, Inc. Methods of purifying polypeptides
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
CA2843197A1 (en) * 2011-07-29 2013-02-07 Eleven Biotherapeutics, Inc. Purified proteins
ES2717536T5 (en) * 2011-11-02 2025-02-04 Hoffmann La Roche Overload and elute chromatography
ES2574614T3 (es) * 2012-05-23 2016-06-21 Glaxosmithkline Biologicals S.A. Procedimiento de determinación de una concentración de una especie de polisorbato en una mezcla
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

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