Patent SG-11201900201Y-A (SG)
Title: Methods for quantitating individual antibodies from a mixture
Inventor: LIU DINGJIANG
IPC: C07K16/06
Filed: 2017-08-08
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))