Title:
EFFECTIVE METHOD FOR MANUFACTURING ANTIBODY-DRUG CONJUGATE
Document Type and Number:
WIPO Patent Application WO/2020/022363
Kind Code:
A1
Abstract:
The present invention is: a method for manufacturing an antibody-drug conjugate in which a drug linker represented by formula (1) (A in the formula representing an antibody binding site) and an antibody are bonded by a thioether bond, the manufacturing method characterized by including (i) a step for reducing an antibody with a reducing agent, (ii) a step for reacting a drug linker intermediate with the antibody reduced in step (i), (iii) a step for adding a reagent having a thiol group and reacting with the drug linker intermediate remaining from step (ii), and (iv) a step for then removing a byproduct derived from the drug linker intermediate by ultrafiltration using a buffer solution containing a salt comprising a strong acid and a strong base; and a method for manufacturing a pharmaceutical composition including the aforementioned antibody-drug conjugate.
Inventors:
YAMAGUCHI TATSUYA (JP)
SAKURATANI KENJI (JP)
SAKURATANI KENJI (JP)
Application Number:
PCT/JP2019/028949
Publication Date:
January 30, 2020
Filing Date:
July 24, 2019
Export Citation:
Assignee:
DAIICHI SANKYO CO LTD (JP)
International Classes:
C07K16/32; A61K9/08; A61K47/18; A61K47/22; A61K47/26; A61K47/68; A61P35/00; A61K31/4745; A61K39/395
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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., 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
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See also references of EP 3828206A4
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
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
DOI T ET AL., LANCET ONCOL, vol. 18, 2017, pages 1512 - 22
TAKEGAWA N ET AL., INT. J. CANCER, vol. 141, 2017, pages 1682 - 1689
OGITANI Y. ET AL., CLINICAL CANCER RESEARCH, vol. 22, no. 20, 29 March 2016 (2016-03-29), pages 5097 - 5108
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, 1999, KLUWER ACADEMIC PUBLISHERS, pages: 69 - 73
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
See also references of EP 3828206A4
Attorney, Agent or Firm:
ISHIBASHI Koki et al. (JP)
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