Title:
METHOD FOR PREPARING A COMPOSITION COMPRISING HIGHLY CONCENTRATED ANTIBODIES BY ULTRAFILTRATION
Document Type and Number:
WIPO Patent Application WO/2013/031237
Kind Code:
A1
Abstract:
The present invention provides a method for preparing a composition comprising highly concentrated antibodies by ultrafiltration in batch concentration mode having a first constant feed rate step and a second controlled feed rate step.
Inventors:
LAU KELBY (US)
BENDER JEAN (US)
TANAKA SAEKO (JP)
WAKAYAMA RUMIKO (JP)
YAMADA HIDENARI (JP)
ISODA TOMONORI (JP)
OH-EDA MASAYOSHI (JP)
BENDER JEAN (US)
TANAKA SAEKO (JP)
WAKAYAMA RUMIKO (JP)
YAMADA HIDENARI (JP)
ISODA TOMONORI (JP)
OH-EDA MASAYOSHI (JP)
Application Number:
PCT/JP2012/005536
Publication Date:
March 07, 2013
Filing Date:
August 31, 2012
Export Citation:
Assignee:
CHUGAI PHARMACEUTICAL CO LTD (JP)
GENENTECH INC (US)
LAU KELBY (US)
BENDER JEAN (US)
TANAKA SAEKO (JP)
WAKAYAMA RUMIKO (JP)
YAMADA HIDENARI (JP)
ISODA TOMONORI (JP)
OH-EDA MASAYOSHI (JP)
GENENTECH INC (US)
LAU KELBY (US)
BENDER JEAN (US)
TANAKA SAEKO (JP)
WAKAYAMA RUMIKO (JP)
YAMADA HIDENARI (JP)
ISODA TOMONORI (JP)
OH-EDA MASAYOSHI (JP)
International Classes:
B01D61/22; B01D61/14; C07K1/34
Domestic Patent References:
| WO2010111378A1 | 2010-09-30 | |||
| WO2004001007A2 | 2003-12-31 | |||
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| WO1999051743A1 | 1999-10-14 | |||
| WO2009072604A1 | 2009-06-11 | |||
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| WO2001066737A1 | 2001-09-13 | |||
| WO2011090088A1 | 2011-07-28 | |||
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Foreign References:
| EP1623752A2 | 2006-02-08 | |||
| US6375847B1 | 2002-04-23 | |||
| US20070116700A1 | 2007-05-24 | |||
| US20090214522A1 | 2009-08-27 | |||
| JPH0513103A | 1993-01-22 | |||
| US5795965A | 1998-08-18 |
Other References:
KIM KJ; FANE AG; FELL CJD; JOY DC: "Fouling mechanisms of membranes during protein ultrafiltration", J. MEMBR. SCI., vol. 68, 1992, pages 79
LIU J; NGUYEN MDH; ANDYA JD; SHIRE SJ: "Reversible selfassociation increases the viscosity of a concentrated monoclonal antibody in aqueous solution", J PHARM SCI, vol. 94, 2005, pages 1928 - 1940
LUO R; WAGHMARE R; KRISHNAN M; ADAMS C; POON E; KAHN D: "High concentration UF/DF of a monoclonal antibody. Strategy for optimization and scale-up", BIOPROCESS INT., vol. 4, 2006, pages 44
SHILOACH J; MARTIN N; MOES H: "Tangential flow filtration", ADV BIOTECHNOL PROCESS, vol. 8, 1988, pages 97 - 125
SHIRE SJ; SHAHROKH Z; LIU J: "Challenges in the development of high protein concentration formulations", J PHARM SCI, vol. 93, 2004, pages 1390 - 1402
SHIRE SJ: "Formulation and manufacturability of biologics", CURR OPIN BIOTECHNOL, vol. 20, 2009, pages 708 - 714
SUKI A; FANE AG; FELL CJD: "Flux decline in protein ultrafiltration", J. MEMBR. SCI., vol. 21, 1984, pages 269
SUKI A; FANE AG; FELL CJD: "Modeling fouling mechanisms in protein ultrafiltration", J. MEMBR. SCI., vol. 27, 1986, pages 181
TURKER M; HUBBLE J: "Membrane fouling in a constant-flux ultrafiltration cell", J. MEMBR. SCI., vol. 34, 1987, pages 267
VAN REIS R; ZYDNEY A: "Membrane separations in biotechnology", CURR OPIN BIOTECHNOL, vol. 12, 2001, pages 208 - 211
LIU J; NGUYEN MDH; ANDYA JD; SHIRE SJ: "Reversible selfassociation increases the viscosity of a concentrated monoclonal antibody in aqueous solution", J PHARM SCI, vol. 94, 2005, pages 1928 - 1940
LUO R; WAGHMARE R; KRISHNAN M; ADAMS C; POON E; KAHN D: "High concentration UF/DF of a monoclonal antibody. Strategy for optimization and scale-up", BIOPROCESS INT., vol. 4, 2006, pages 44
SHILOACH J; MARTIN N; MOES H: "Tangential flow filtration", ADV BIOTECHNOL PROCESS, vol. 8, 1988, pages 97 - 125
SHIRE SJ; SHAHROKH Z; LIU J: "Challenges in the development of high protein concentration formulations", J PHARM SCI, vol. 93, 2004, pages 1390 - 1402
SHIRE SJ: "Formulation and manufacturability of biologics", CURR OPIN BIOTECHNOL, vol. 20, 2009, pages 708 - 714
SUKI A; FANE AG; FELL CJD: "Flux decline in protein ultrafiltration", J. MEMBR. SCI., vol. 21, 1984, pages 269
SUKI A; FANE AG; FELL CJD: "Modeling fouling mechanisms in protein ultrafiltration", J. MEMBR. SCI., vol. 27, 1986, pages 181
TURKER M; HUBBLE J: "Membrane fouling in a constant-flux ultrafiltration cell", J. MEMBR. SCI., vol. 34, 1987, pages 267
VAN REIS R; ZYDNEY A: "Membrane separations in biotechnology", CURR OPIN BIOTECHNOL, vol. 12, 2001, pages 208 - 211
Attorney, Agent or Firm:
SHIMIZU, Hatsushi et al. (1-1-1 Oroshi-machi, Tsuchiura-sh, Ibaraki 47, JP)
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