Patent SG-11201901228Q-A (SG)
Title: Chromatography method for quantifying a non-ionic surfactant in a composition comprising the non-ionic surfactant and a polypeptide
Inventor: MONTTI MARY
IPC: G01N30/96
Filed: 2017-08-14
Abstract: INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property 111111411 0 11101 0I0 11111 01 100011114 100 1101 0111 I MEV OEN Organization International Bureau (10) International Publication Number (43) International Publication Date .....0\"\"\" WO 2018/035025 Al 22 February 2018 (22.02.2018) WIP0 I PCT (51) International G01N 30/96 GO1N 30/36 (21) International (22) International (25) Filing Language: (26) Publication (30) Priority Data: 62/375,373 (71) Applicant BE, BG, CH, GR, HR, HU, NL, NO, PL, TECH, INC. CA 94080-4990 Patent Classification: TR only): F. HOFFMANN LA-ROCHE AG [CH/CH]; (2006.01) A61K 47/00 (2006.01) Grenzacherstrasse 124, 4070 Basel (CH). (2006.01) (72) Inventors: MONTTI, Mary; c/o Genentech, Inc., 1 Application Number: DNA Way, South San Francisco, CA 94080-4990 (US). PCT/US2017/046725 BEARDSLEY, Richard L.; c/o Genentech, Inc., 1 DNA Filing Date: Way, South San Francisco, CA 94080-4990 (US). CHINN, 14 August 2017 (14.08.2017) Michael S.; c/o Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080-4990 (US). English (74) Agent: DONAHUE, Brian A. et al.; Morrison & Foerster Language: English LLP, 755 Page Mill Road, Palo Alto, CA 94304-1018 (US). (81) Designated States (unless otherwise indicated, for every 15 August 2016 (15.08.2016) US kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, (for all designated States except AL, AT, BA, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, CN, CY, CZ, DE, DK, EE, ES, FI, FR, GB, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, IE, IN, IS, IT, LT, LU, LV, MC, MK, MT, HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, PT, RO, RS, SE, SI, SK, SM, TR): GENEN- KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, [US/US]; 1 DNA Way, South San Francisco, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, (US). OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, (for AL, AT, BA, BE, BG, CH, CN, CY, CZ, DE, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, FI, FR, GB, GR, HR, HU, IE, IN, IS, IT, LT, LU, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, (71) Applicant = DK, EE, ES, LV, MC, MK, = EE METHOD FOR QUANTIFYING A NON-IONIC SURFACTANT IN A COMPOSITION COM- SURFACTANT AND A POLYPEPTIDE (54) Title: CHROMATOGRAPHY = PRISING THE NON-IONIC = = = - — — — PS20-free Al ADC _ EE PS20 standard = 70.0 — m V 100.0 9 85.0,•0 0: 80.0, 0 75.0, 70.0, 65. • • 60.0 , • 50 55. °, • ,„ 45.0 , ' 0, it 3 4lJA 30 0 5.0 J • • \• / \ 25.0 \" 2 -• N 1 I \ 20.0 ,. _-.-.,--•7 i \ ---• -- _ - ---\" - ' /-* — `-!---2 - ' 25.0 _.1, = 50.0 = = 37.5 = = _ = 12.5 2% formic acid in MeOH: 10.0% Flow: 1.000 ml/min 10.0 m i n 0 and the Also _ 0 0 0 0 0 0 0 0 0 0 0 N o ( ?, o , 5 o N o 0 0 l o 0 0 N 2.• • 3. bv• 6• 6. 1 • 6• (• 1 \ N 1 \ '\ '\ 1 \ 1 \ N '\ 1 \ fi, FIG. 1 invention provides methods for quantifying a non-ionic surfactant in a composition comprising a polypeptide where the quantification exhibits reduced interference between the non-ionic surfactant and the polypeptide. where the composition further includes N-acetyl tryptophan, and the quantification exhibits reduced interference ionic surfactant, the polypeptide, and N-acetyl tryptophan. O• 1-1 11 in ei © 11 in C (57) : The -- -- GC non- ionic surfactant, ,-1 provided are methods 0 between the non- ei O [Continued on next page] WO 2018/035025 Al MIDEDIMOMMIDIREIHNIOMINIMOHMEHOIS 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))