Title:
METHOD FOR PRODUCING ANTIBODY-DRUG CONJUGATE
Document Type and Number:
WIPO Patent Application WO/2022/014698
Kind Code:
A1
Abstract:
A method for producing an antibody-drug conjugate composition including (i) a step for causing antibodies to react with a reducing agent and obtaining antibodies having a thiol group, followed by (ii) a step for causing the antibodies having a thiol group obtained in step (i) to react with a drug linker intermediary, the production method being characterized in that step (i) is carried out until the constitution ratio of antibodies having four heavy-light interchain thiols and the constitution ratio of antibodies having four heavy-heavy interchain thiols reach steady values.
Inventors:
SATO HITOSHI (JP)
SASORI YUKA (JP)
FUKATSU DAISUKE (JP)
SASORI YUKA (JP)
FUKATSU DAISUKE (JP)
Application Number:
PCT/JP2021/026784
Publication Date:
January 20, 2022
Filing Date:
July 16, 2021
Export Citation:
Assignee:
DAIICHI SANKYO CO LTD (JP)
International Classes:
C07K16/00
Domestic Patent References:
| WO2017002776A1 | 2017-01-05 | |||
| WO2020022363A1 | 2020-01-30 | |||
| WO2005084390A2 | 2005-09-15 | |||
| WO2017002776A1 | 2017-01-05 | |||
| WO2007112193A2 | 2007-10-04 | |||
| WO2008033891A2 | 2008-03-20 | |||
| WO2009100194A2 | 2009-08-13 | |||
| WO2009134976A1 | 2009-11-05 | |||
| WO2009134977A1 | 2009-11-05 | |||
| WO2010093395A1 | 2010-08-19 | |||
| WO2011130613A1 | 2011-10-20 | |||
| WO2011130616A1 | 2011-10-20 | |||
| WO2013055993A1 | 2013-04-18 | |||
| WO2014057687A1 | 2014-04-17 | |||
| WO2014107024A1 | 2014-07-10 | |||
| WO2014134457A2 | 2014-09-04 | |||
| WO2014145090A1 | 2014-09-18 | |||
| WO2015098099A1 | 2015-07-02 | |||
| WO1990007861A1 | 1990-07-26 | |||
| WO1999054342A1 | 1999-10-28 | |||
| WO2000061739A1 | 2000-10-19 | |||
| WO2002031140A1 | 2002-04-18 | |||
| WO2019044947A1 | 2019-03-07 |
Foreign References:
| JP2008500961A | 2008-01-17 | |||
| US6214345B1 | 2001-04-10 | |||
| US20020083067A1 | 2002-06-27 | |||
| US20030026577A1 | 2003-02-06 | |||
| US20040054622A1 | 2004-03-18 | |||
| US20050112919A1 | 2005-05-26 | |||
| US20060135371A1 | 2006-06-22 | |||
| US5821337A | 1998-10-13 |
Other References:
SARRUT, MORGAN ET AL.: "Analysis of antibody-drug conjugates by comprehensive on-line two- dimensional hydrophobic interaction chromatography x reversed phase liquid chromatography hyphenated to high resolution mass spectrometry . II- Identification of sub-units for the characterization of even and odd load drug species", JOURNAL OF CHROMATOGRAPHY B, vol. 1032, 2016, pages 91 - 102, XP055414396, DOI: 10.1016/j.jchromb.2016.06.049
DUCRY, L. ET AL., BIOCONJUGATE CHEM, vol. 21, 2010, pages 5 - 13
ALLEY, S. C. ET AL., CURRENT OPINION IN CHEMICAL BIOLOGY, vol. 14, 2010, pages 529 - 537
DAMLE N. K, EXPERT OPIN. BIOL. THER, vol. 4, 2004, pages 1445 - 1452
SENTER P. D. ET AL., NATURE BIOTECHNOLOGY, vol. 30, 2012, pages 631 - 637
HOWARD A ET AL., J CLIN ONCOL, vol. 29, pages 398 - 405
CELL DEATH AND DIFFERENTIATION, vol. 15, 2008, pages 751 - 761
MOLECULAR BIOLOGY OF THE CELL, vol. 15, December 2004 (2004-12-01), pages 5268 - 5282
BIO TECHNIQUES, vol. 28, January 2000 (2000-01-01), pages 162 - 165
KOHLERMILSTEIN, NATURE, vol. 256, 1975, pages 495 - 497
"Monoclonal Antibodies", 1980, PLENUM PRESS, pages: 365 - 367
PROC. NATL. ACAD. SCI. USA, vol. 81, 1984, pages 6851 - 6855
NATURE, vol. 321, 1986, pages 522 - 525
TOMIZUKA, K ET AL., NATURE GENETICS, vol. 16, 1997, pages 133 - 143
KUROIWA, Y, NUCL. ACIDS RES, vol. 26, 1998, pages 3447 - 3448
YOSHIDA, H, ANIMAL CELL TECHNOLOGY:BASIC AND APPLIED ASPECTS, vol. 10, pages 69 - 73
"Kluwer Academic Publishers", 1999
TOMIZUKA, K, PROC. NATL. ACAD. SCI. USA, vol. 97, 2000, pages 722 - 727
WORMSTONE, I. M, INVESTIGATIVE OPHTHALMOLOGY VISUAL SCIENCE, vol. 43, no. 7, 2002, pages 2301 - 2308
CARMEN, S, BRIEFINGS IN FUNCTIONAL GENOMICS AND PROTEOMICS, vol. 1, no. 2, 2002, pages 189 - 203
SIRIWARDENA, D, OPHTHALMOLOGY, vol. 109, no. 3, 2002, pages 427 - 431
JOURNAL OF CHROMATOGRAPHY A, vol. 705, 1995, pages 129 - 134
ANALYTICAL BIOCHEMISTRY, vol. 360, 2007, pages 75 - 83
PROTEIN SCIENCE, vol. 4, 1995, pages 2411 - 2423
DUCRY, L. ET AL., BIOCONJUGATE CHEM, vol. 21, 2010, pages 5 - 13
ALLEY, S. C. ET AL., CURRENT OPINION IN CHEMICAL BIOLOGY, vol. 14, 2010, pages 529 - 537
DAMLE N. K, EXPERT OPIN. BIOL. THER, vol. 4, 2004, pages 1445 - 1452
SENTER P. D. ET AL., NATURE BIOTECHNOLOGY, vol. 30, 2012, pages 631 - 637
HOWARD A ET AL., J CLIN ONCOL, vol. 29, pages 398 - 405
CELL DEATH AND DIFFERENTIATION, vol. 15, 2008, pages 751 - 761
MOLECULAR BIOLOGY OF THE CELL, vol. 15, December 2004 (2004-12-01), pages 5268 - 5282
BIO TECHNIQUES, vol. 28, January 2000 (2000-01-01), pages 162 - 165
KOHLERMILSTEIN, NATURE, vol. 256, 1975, pages 495 - 497
"Monoclonal Antibodies", 1980, PLENUM PRESS, pages: 365 - 367
PROC. NATL. ACAD. SCI. USA, vol. 81, 1984, pages 6851 - 6855
NATURE, vol. 321, 1986, pages 522 - 525
TOMIZUKA, K ET AL., NATURE GENETICS, vol. 16, 1997, pages 133 - 143
KUROIWA, Y, NUCL. ACIDS RES, vol. 26, 1998, pages 3447 - 3448
YOSHIDA, H, ANIMAL CELL TECHNOLOGY:BASIC AND APPLIED ASPECTS, vol. 10, pages 69 - 73
"Kluwer Academic Publishers", 1999
TOMIZUKA, K, PROC. NATL. ACAD. SCI. USA, vol. 97, 2000, pages 722 - 727
WORMSTONE, I. M, INVESTIGATIVE OPHTHALMOLOGY VISUAL SCIENCE, vol. 43, no. 7, 2002, pages 2301 - 2308
CARMEN, S, BRIEFINGS IN FUNCTIONAL GENOMICS AND PROTEOMICS, vol. 1, no. 2, 2002, pages 189 - 203
SIRIWARDENA, D, OPHTHALMOLOGY, vol. 109, no. 3, 2002, pages 427 - 431
JOURNAL OF CHROMATOGRAPHY A, vol. 705, 1995, pages 129 - 134
ANALYTICAL BIOCHEMISTRY, vol. 360, 2007, pages 75 - 83
PROTEIN SCIENCE, vol. 4, 1995, pages 2411 - 2423
Attorney, Agent or Firm:
ISHIBASHI Koki et al. (JP)
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