SG11201900201YA - Methods for quantitating individual antibodies from a mixture - Google Patents

Methods for quantitating individual antibodies from a mixture

Info

Publication number
SG11201900201YA
SG11201900201YA SG11201900201YA SG11201900201YA SG11201900201YA SG 11201900201Y A SG11201900201Y A SG 11201900201YA SG 11201900201Y A SG11201900201Y A SG 11201900201YA SG 11201900201Y A SG11201900201Y A SG 11201900201YA SG 11201900201Y A SG11201900201Y A SG 11201900201YA
Authority
SG
Singapore
Prior art keywords
mixture
international
antibody molecule
quantitating
tarrytown
Prior art date
Application number
SG11201900201YA
Inventor
Dingjiang Liu
Lin Luo
Long Xu
Original Assignee
Regeneron Pharma
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 Regeneron Pharma filed Critical Regeneron Pharma
Publication of SG11201900201YA publication Critical patent/SG11201900201YA/en

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Classifications

    • 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
    • B01D15/30—Partition 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
    • G01N30/02—Column chromatography
    • G01N30/88—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • 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
    • 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
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/06—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/06—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065—Purification, fragmentation
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/08—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses
    • C07K16/10—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses from RNA viruses
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/08—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses
    • C07K16/10—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses from RNA viruses
    • C07K16/1002—Coronaviridae
    • 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
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6854—Immunoglobulins
    • 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
    • G01N2030/022—Column chromatography characterised by the kind of separation mechanism
    • G01N2030/027—Liquid 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
    • G01N30/02—Column chromatography
    • G01N30/88—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86
    • G01N2030/8809—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample
    • G01N2030/8813—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample biological materials
    • G01N2030/8831—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample biological materials involving peptides or proteins

Abstract

INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property MD HIM 0 ill HON HI 1 0 01111 VIII H I 11110 III OEN Organization International Bureau (10) International Publication Number (43) International Publication Date ......0\" WO 2018/034885 Al 22 February 2018 (22.02.2018) WIP0 I PCT (51) International Patent Classification: (72) Inventors: LIU, Dingjiang; c/o Regeneron Pharmaceuti- A61K 39/395 (2006.01) C07K 16/00 (2006.01) cals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY BOLD 15/30 (2006.01) C07K 16/06 (2006.01) 10591 (US). LUO, Lin; c/o Regeneron Pharmaceuticals, (21) International Application Number: Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591 PCT/US2017/045855 (US). XU, Long; Rm 501 No. 5 Ln 2059 Tongchuan Rd., Shanghai, 200333 (CN). (22) International Filing Date: (74) Agent: RUSSELL, Thara; Bookoff McAndrews, PLLC, 08 August 2017 (08.08.2017) 2401 Pennsylvania Avenue, NW, Suite 450, Washington, (25) Filing Language: English DC 20037 (US). (26) Publication Language: English (81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, (30) Priority Data: AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, 62/375,887 16 August 2016 (16.08.2016) US CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, (71) Applicant: REGENERON PHARMACEUTICALS, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, INC. [US/US]; 777 Old Saw Mill River Road, Tarrytown, HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, NY 10591 (US). KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, (54) Title: METHODS FOR QUANTITATING INDIVIDUAL ANTIBODIES FROM A MIXTURE = = FIG. i — 0.048 - _ 0.044- I 1 I 0.040- 0.036 - 0.032- 0.09_8- = i A I l mAb A -- - mAb B __ _ cFDS mAb C = 0.024 _ — AU 0.020- - 0.016- = 0.012- = 0.008- = — M- O = I I \I - , ....... 0.000-'• -0.008- .. _ 0.00 280 4.00 6.U0 8.60 moo 1200 1480 16:00 18:00 20:00 22:00 24:00 2600 2800 30:00 32:00 34:00 3683 38:00 40:00 Minutes ti In (57) : The present disclosure relates to, inter alia, a method of quantitating an amount of an antibody molecule from a mixture GO ot comprising two or more antibody molecules, comprising separating each of the two or more antibody molecules from the mixture by il• hydrophobic interaction chromatography high performance liquid chromatography (HIC-HPLC) and quantitating an amount of each C antibody molecule, wherein the molecular weight of each antibody molecule is within 15 kDa of any other antibody molecule in the ---. mixture and either each antibody molecule is different from another antibody molecule in the mixture by more than about 0.25 unit on W D the Kyte & Doolittle hydropathy scale or each of the antibody molecules when run alone on HIC-HPLC elutes at distinct run time with 1-1 © little overlap from the other antibody molecules in the mixture, or both. ei C [Continued on next page] WO 2018/034885 Al MIDEDIMOMOIDEIREIHNIMIEHMOMEHOIS SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG). Published: — with international search report (Art. 21(3))
SG11201900201YA 2016-08-16 2017-08-08 Methods for quantitating individual antibodies from a mixture SG11201900201YA (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201662375887P 2016-08-16 2016-08-16
PCT/US2017/045855 WO2018034885A1 (en) 2016-08-16 2017-08-08 Methods for quantitating individual antibodies from a mixture

Publications (1)

Publication Number Publication Date
SG11201900201YA true SG11201900201YA (en) 2019-02-27

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Family Applications (1)

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SG11201900201YA SG11201900201YA (en) 2016-08-16 2017-08-08 Methods for quantitating individual antibodies from a mixture

Country Status (14)

Country Link
US (5) US11020686B2 (en)
EP (2) EP4183414A1 (en)
JP (2) JP2019529350A (en)
KR (3) KR20230041834A (en)
CN (1) CN109641050A (en)
AU (1) AU2017312785A1 (en)
BR (1) BR112019000872A2 (en)
CA (1) CA3031742A1 (en)
EA (1) EA201990317A1 (en)
IL (2) IL309453A (en)
MX (1) MX2019000935A (en)
MY (1) MY196321A (en)
SG (1) SG11201900201YA (en)
WO (1) WO2018034885A1 (en)

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