Title:
ANTIBODY-DRUG CONJUGATE PREPARATION AND LYOPHILIZATION FOR SAME
Document Type and Number:
WIPO Patent Application WO/2019/039483
Kind Code:
A1
Abstract:
Provided are a pharmaceutical composition containing: (i) an antibody-drug conjugate comprising a drug linker represented by the following formula (wherein A indicates the position of the bond with the antibody) and an antibody bonded by a thioether bond; (ii) a histidine buffer; (iii) sucrose or trehalose; and (iv) a surfactant; as well as a lyophilization method for said pharmaceutical composition.
Inventors:
KAMII TETSUO (JP)
NISHIMOTO NORIHIRO (JP)
NISHIMOTO NORIHIRO (JP)
Application Number:
PCT/JP2018/030882
Publication Date:
February 28, 2019
Filing Date:
August 22, 2018
Export Citation:
Assignee:
DAIICHI SANKYO CO LTD (JP)
International Classes:
A61K39/395; A61K9/08; A61K9/19; A61K31/4745; A61K47/10; A61K47/22; A61K47/26; A61K47/68; A61P35/00; A61P35/02; C07K16/00; C07K19/00
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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
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OGITANI Y ET AL., CANCER SCIENCE, vol. 107, 2016, pages 1039 - 1046
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. U.S.A., 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, 1999, KLUWER ACADEMIC PUBLISHERS, pages: 69 - 73
TOMIZUKA, K., PROC. NATL. ACAD. SCI. USA, vol. 97, 2000, pages 722 - 727
WORMSTONE, I. M. ET AL., INVESTIGATIVE OPHTHALMOLOGY & VISUAL SCIENCE, vol. 43, no. 7, 2002, pages 2301 - 2308
CARMEN, S. ET AL., BRIEFINGS IN FUNCTIONAL GENOMICS AND PROTEOMICS, vol. 1, no. 2, 2002, pages 189 - 203
SIRIWARDENA, D. ET AL., 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
HERMANSON, G. T: "Bioconjugate Techniques", 1996, ACADEMIC PRESS, pages: 56 - 136,456-493
See also references of EP 3673918A4
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
OGITANI Y. ET AL., CLINICAL CANCER RESEARCH, vol. 22, no. 20, 2016, pages 5097 - 5108
OGITANI Y ET AL., CANCER SCIENCE, vol. 107, 2016, pages 1039 - 1046
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. U.S.A., 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, 1999, KLUWER ACADEMIC PUBLISHERS, pages: 69 - 73
TOMIZUKA, K., PROC. NATL. ACAD. SCI. USA, vol. 97, 2000, pages 722 - 727
WORMSTONE, I. M. ET AL., INVESTIGATIVE OPHTHALMOLOGY & VISUAL SCIENCE, vol. 43, no. 7, 2002, pages 2301 - 2308
CARMEN, S. ET AL., BRIEFINGS IN FUNCTIONAL GENOMICS AND PROTEOMICS, vol. 1, no. 2, 2002, pages 189 - 203
SIRIWARDENA, D. ET AL., 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
HERMANSON, G. T: "Bioconjugate Techniques", 1996, ACADEMIC PRESS, pages: 56 - 136,456-493
See also references of EP 3673918A4
Attorney, Agent or Firm:
ISHIBASHI Koki et al. (JP)
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