HUE035685T2 - Túlterheléses és elúciós kromatográfia - Google Patents

Túlterheléses és elúciós kromatográfia Download PDF

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Publication number
HUE035685T2
HUE035685T2 HUE12845437A HUE12845437A HUE035685T2 HU E035685 T2 HUE035685 T2 HU E035685T2 HU E12845437 A HUE12845437 A HU E12845437A HU E12845437 A HUE12845437 A HU E12845437A HU E035685 T2 HUE035685 T2 HU E035685T2
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Hungary
Prior art keywords
antibody
polypeptide
chromatography
antibodies
conductivity
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HUE12845437A
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English (en)
Inventor
Deepa Nadarajah
Amit Mehta
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Hoffmann La Roche
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=48192803&utm_source=***_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HUE035685(T2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Hoffmann La Roche filed Critical Hoffmann La Roche
Publication of HUE035685T2 publication Critical patent/HUE035685T2/hu

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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/16—Extraction; Separation; Purification by chromatography
    • C07K1/18—Ion-exchange chromatography
    • 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
    • B01D15/10—Selective adsorption, e.g. chromatography characterised by constructional or operational features
    • B01D15/14—Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to the introduction of the feed to the apparatus
    • 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
    • B01D15/42—Selective adsorption, e.g. chromatography characterised by the development mode, e.g. by displacement or by elution
    • B01D15/424—Elution mode
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/16—Extraction; Separation; Purification by chromatography
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/16—Extraction; Separation; Purification by chromatography
    • C07K1/165—Extraction; Separation; Purification by chromatography mixed-mode chromatography
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/16—Extraction; Separation; Purification by chromatography
    • C07K1/20—Partition-, reverse-phase or hydrophobic interaction chromatography
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/16—Extraction; Separation; Purification by chromatography
    • C07K1/22—Affinity chromatography or related techniques based upon selective absorption processes
    • 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
    • B01D15/32—Bonded phase chromatography
    • B01D15/325—Reversed phase
    • B01D15/327—Reversed phase with hydrophobic interaction
    • 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
    • B01D15/361—Ion-exchange
    • B01D15/363—Anion-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 - B01D15/36
    • B01D15/3804—Affinity chromatography
    • 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 - B01D15/36
    • B01D15/3847—Multimodal interactions

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  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • General Health & Medical Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Medicinal Chemistry (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Immunology (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)

Claims (6)

  1. SzstbsdnlsnS igénypontok L Eljárás palipspíki tisztítására a poiipepnd mellest ssge vagy több szennyező anyagot s&amp;ríaim&amp;ző ,e\ aounAv:, a,nsk oha-sn, <aiia'n'a?. r 3 \ \ Î , S X X i \>. xv IxxS 1 Ιχ ! ' <<. >!-·. \ p '..·, « X ' ( \ I 3 »S s 5' X ii is anyagra.: a. kr;>rns;tögrá:llás> anyagnak: s pollpepUdáei. kapcsolatos- dinamikus megkötő kapae itssástssk 20«szot»s inennyiaőgéban olyan feltöitési puffer haszaálaiávaix aboi a kfomatográtnls ttnyag megoszlási hányadosa a pöiipeptiárö-nagyóbh, mint 38, fej a polipepsitl ohiáiátö? a kromatográfiás anyagból eiúeiős puffernd olyan körülmények között, ahol az egy vagy több szennyező' anyag a kromatográfiás: anyaghoz kötődve -marad, aminél az előeiös puffét vezetőképessége-\ \tbfe i ' U; ( \v !' I U> ; ·.. kp, ί e , S i. v x· '' > sypi'tö >i i ο-', pnpnxtör íxiT'ina.n kj'V'aix'gi iba, etön-'n t-atö-x^ ,ó\ önevt
  2. 2. Az, 1 · igénypont szérián eljárás, ahol a polipeptid antitest vagy irarounadhezin. 3, A 2, igénypont szerinti eljárás, ahoi az antitest monoklönális antitest.- 4, A 3. igénypont szerinti eljárás, ahol a ropnóktönéjis antitösi kpnéra airlősst, hnroatsizált- antitest: vagy hunián antitest, s λ ? 3x',enyp,'i« ί.’,ί«!· •'haïes aboi ,tz ,-οΟίοο <-g\ mámon megköt·' hágná nSoun ,íh<'> -'peront h;,,: n az antigén megkötő- fragmentum egy fab fragmentum, bab’ Iragntentmn, .PCáb’jj fragmentum, soFv:, dirseFv', bí-aeFV·, í.,nxk'!í' idu ’fti·'*tös tö, síi \fe iO'P'fAx i,'S> ss ast-no l-bt'l, .fewest ane·, O'nte-k
  3. 6. Az i. igénypont szettnti eljárás, aboi a poiipepud enzim, hormon, fözlös fehérje, Pedartalmn fehérje, immtmk-öpjagáím«, eitokin vagy iníerleokln. ?.. Az -1,--61 igénypontok feámtelyikV: szerinti eljárás, ahol s legalább egy szennyező, anyag kínai hbreaög ptöetsszek: lekérje (CHOP), gazaas^ít lekérje (HCP), kimosödotr Préséin A,"katbozipeptldáz B, nakleinsavak,.1?NS,. termék változótok, aggrógált fbhásje, aepienyaszlp íáptakö Összetevő, geníímriehr, polipeptid ffagméoionr,. éotioioxio és vírusos érédétő szénnyéződés közös egy vagy több
    5. Αχ Ί---?. Igénypontok báriPelylks szerinti eljárás, alsói ·&amp; töitöh'ési slh'ssség. megközelítőleg- SO gir és megközelítőleg 2öítö g/1 között vám
  4. 9. Az 1--.10 igéfíypoatok -.bármelyike Szeriád eiukés, ahol a késtöbnényl: a krorstaíegráíjás anyagra a .krOrnategfáfiáá anyagnak az egy vagy több szoirayezó anyaggal kapcsolások dtösrnikns msgkötö: kapacitása körűit mennyi ségbers töltj sík tél,
  5. 10. Az 1c. igénypont, szerinti eljéris, ahol a. iéitöiíssl puffer vezetőképessége megközelítőleg 4,0 mS és fisagközélitölsg 7,0 m$ közöts van az elûciès pufrèr vezetőképessége pedig megközelítőleg 8,8 és megközelítőleg ?:0 stö között vsat,
  6. 11. Az 1 igénypont szerinti élj finis, ahol az. elöciős puifer vezetőképessége fokozatosan 5,5 roS-töi Eb rnS-re csökken megközelítőleg 1 ö-oszlop tértogattm (CV) belől. í \ x>t!é -t S xt xlp IS Ö >> ! !«>.< ", ! x' ' < ! d\ > 10 ! i >. ! ! χΟ ' SÓ Ή ' L1, A 13, igönypeni .szerinti eljárás, ahoi a téítőUésl p«fW piLja íoegközéiitobg 4 és megkőzeiilöíég 9 között van, az eiènios puffot- pHoa pedig o-iegköí-elitöieg 4 és magi?özeHtöíég 9 között víssjfj.· 14, Λ 30- igénypont szerié;; eljárás, ahoi az elóciós poílkrt pH-ga i-iagyohb, rtílnt a léltöllésl poifer gl-l-ja, if \ 14 -«ientpct·! '/e ints elsüss, Ju4 \ fenoke-n pufter pli-hs nugkozeiiOkg t es m<?td,ö.tehiök g íl vsístí \3H e\ a /«nés parik' pii-> s ρ“0'· "-eel >\eín<.<Ls ·', η egkxvx turiee '» ko\«t \ ,·;< lé, Λζ 1-4 5, igénypontok bároicíyike szőriét! eijaras, shöi a készítmény alíimtás kgrmatográfia, katíoncserélp krosnaiogs-áila, snlöncsarélő któtpatögrálla, kévattágyás krosnaiogíáfía: vagy hiérotob kölcsönhatási kross· stopra fia oloense. P kín s$,e '\)X'Ot s,\rs<'t. e sa as sä ri r stint !« kfc'nPos ahîthoieü \ 'mna\ csm'a
HUE12845437A 2011-11-02 2012-11-02 Túlterheléses és elúciós kromatográfia HUE035685T2 (hu)

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EP (3) EP3257564B2 (hu)
JP (4) JP6356607B2 (hu)
KR (1) KR20140091721A (hu)
CN (2) CN104023804B (hu)
AU (1) AU2012323995B2 (hu)
BR (1) BR112014010406A2 (hu)
CA (1) CA2854330A1 (hu)
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ES (2) ES2637423T5 (hu)
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HR (1) HRP20190485T1 (hu)
HU (2) HUE035685T2 (hu)
IL (1) IL232146A0 (hu)
LT (1) LT3257564T (hu)
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