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Human antibody kappa type light chain complex-containing composition and method for producing same NEW_EN

Foreign code F170009203
File No. AF12-18WO
Posted date Sep 12, 2017
Country EPO
Application number 14838038
Gazette No. 3037434
Date of filing Aug 13, 2014
Gazette Date Jun 29, 2016
International application number JP2014071379
International publication number WO2015025786
Date of international filing Aug 13, 2014
Date of international publication Feb 26, 2015
Priority data
  • P2013-170414 (Aug 20, 2013) JP
  • 2014WO-JP71379 (Aug 13, 2014) WO
Title Human antibody kappa type light chain complex-containing composition and method for producing same NEW_EN
Abstract (EP3037434)
A human antibody º type light chain complex-containing composition includes a complex in which a human antibody º type light chain is bound to one or more kinds of metal ions selected from the group consisting of Group 10 elements, Group 11 elements, and Group 12 elements.
The human antibody º type light chain is a dimer, cysteines at C terminals of two human antibody º type light chains are bound to each other via the metal ion, and 0.1 mol or more of the metal ion is bound per 1 mol of the human antibody º type light chain.
Scope of claims [claim1]
1. A human antibody kappa type light chain complex-containing composition, comprising: a complex in which a human antibody kappa type light chain is bound to one or more kinds of metal ions selected from the group consisting of Group 10 elements, Group 11 elements, and Group 12 elements, wherein the human antibody kappa type light chain is a dimer, and cysteines at C terminals of two human antibody kappa type light chains are bound to each other via the metal ion, and wherein 0.1 mol or more of the metal ion is bound per 1 mol of the human antibody kappa type light chain.
[claim2]
2. The human antibody kappa type light chain complex-containing composition according to Claim 1,
wherein the metal ion is one or more selected from the group consisting of copper ion, nickel ion, zinc ion, gold ion, silver ion, and platinum ion.
[claim3]
3. The human antibody kappa type light chain complex-containing composition according to Claim 1 or 2,
wherein the human antibody kappa type light chain is selected from the group consisting of: (1) a polypeptide in which a variable region is represented by an amino acid sequence of SEQ ID NO. 1 or an amino acid sequence obtained by substituting, adding or deleting one or several amino acids in the amino acid sequence; (2) a polypeptide in which a variable region is represented by an amino acid sequence of SEQ ID NO. 3 or an amino acid sequence obtained by substituting, adding or deleting one or several amino acids in the amino acid sequence; (3) a polypeptide in which a variable region is represented by an amino acid sequence of SEQ ID NO. 5 or an amino acid sequence obtained by substituting, adding or deleting one or several amino acids in the amino acid sequence; (4) a polypeptide in which a variable region is represented by an amino acid sequence of SEQ ID NO. 7 or an amino acid sequence obtained by substituting, adding or deleting one or several amino acids in the amino acid sequence; (5) a polypeptide in which a variable region is represented by an amino acid sequence of SEQ ID NO. 9 or an amino acid sequence obtained by substituting, adding or deleting one or several amino acids in the amino acid sequence; (6) a polypeptide in which a variable region is represented by an amino acid sequence of SEQ ID NO. 11 or an amino acid sequence obtained by substituting, adding or deleting one or several amino acids in the amino acid sequence; (7) a polypeptide in which a variable region is represented by an amino acid sequence of SEQ ID NO. 13 or an amino acid sequence obtained by substituting, adding or deleting one or several amino acids in the amino acid sequence; (8) a polypeptide in which a variable region is represented by an amino acid sequence of SEQ ID NO. 15 or an amino acid sequence obtained by substituting, adding or deleting one or several amino acids in the amino acid sequence; (9) a polypeptide in which a variable region is represented by an amino acid sequence of SEQ ID NO. 17 or an amino acid sequence obtained by substituting, adding or deleting one or several amino acids in the amino acid sequence; (10) a polypeptide in which a variable region is represented by an amino acid sequence of SEQ ID NO. 19 or an amino acid sequence obtained by substituting, adding or deleting one or several amino acids in the amino acid sequence; (11) a polypeptide in which a variable region is represented by an amino acid sequence of SEQ ID NO.21 or an amino acid sequence obtained by substituting, adding or deleting one or several amino acids in the amino acid sequence; (12) a polypeptide in which a variable region is represented by an amino acid sequence of SEQ ID NO. 23 or an amino acid sequence obtained by substituting, adding or deleting one or several amino acids in the amino acid sequence; (13) a polypeptide in which a variable region is represented by an amino acid sequence of SEQ ID NO. 25 or an amino acid sequence obtained by substituting, adding or deleting one or several amino acids in the amino acid sequence; (14) a polypeptide in which a variable region is represented by an amino acid sequence of SEQ ID NO. 27 or an amino acid sequence obtained by substituting, adding or deleting one or several amino acids in the amino acid sequence; (15) a polypeptide which is represented by an amino acid sequence in which 219 **th cysteine in an amino acid sequence of SEQ ID NO. 2 is substituted with alanine or by an amino acid sequence obtained by substituting, adding or deleting one or several amino acids in the amino acid sequence; (16) a polypeptide in which a variable region is represented by an amino acid sequence of SEQ ID NO. 29 or an amino acid sequence obtained by substituting, adding or deleting one or several amino acids in the amino acid sequence; (17) a polypeptide in which a variable region is represented by an amino acid sequence of SEQ ID NO. 31 or an amino acid sequence obtained by substituting, adding or deleting one or several amino acids in the amino acid sequence; (18) a polypeptide in which a variable region is represented by an amino acid sequence of SEQ ID NO. 33 or an amino acid sequence obtained by substituting, adding or deleting one or several amino acids in the amino acid sequence; (19) a polypeptide in which a variable region is represented by an amino acid sequence of SEQ ID NO. 35 or an amino acid sequence obtained by substituting, adding or deleting one or several amino acids in the amino acid sequence; (20) a polypeptide in which a variable region is represented by an amino acid sequence of SEQ ID NO. 37 or an amino acid sequence obtained by substituting, adding or deleting one or several amino acids in the amino acid sequence; (21) a polypeptide in which a variable region is represented by an amino acid sequence of SEQ ID NO. 39 or an amino acid sequence obtained by substituting, adding or deleting one or several amino acids in the amino acid sequence; (22) a polypeptide in which a variable region is represented by an amino acid sequence of SEQ ID NO. 41 or an amino acid sequence obtained by substituting, adding or deleting one or several amino acids in the amino acid sequence; (23) a polypeptide in which a variable region is represented by an amino acid sequence of SEQ ID NO. 43 or an amino acid sequence obtained by substituting, adding or deleting one or several amino acids in the amino acid sequence; (24) a polypeptide in which a variable region is represented by an amino acid sequence of SEQ ID NO. 45 or an amino acid sequence obtained by substituting, adding or deleting one or several amino acids in the amino acid sequence; (25) a polypeptide in which a variable region is represented by an amino acid sequence of SEQ ID NO. 47 or an amino acid sequence obtained by substituting, adding or deleting one or several amino acids in the amino acid sequence; (26) a polypeptide in which a variable region is represented by an amino acid sequence of SEQ ID NO. 49 or an amino acid sequence obtained by substituting, adding or deleting one or several amino acids in the amino acid sequence; and (27) a polypeptide in which a variable region is represented by an amino acid sequence of SEQ ID NO. 51 or an amino acid sequence obtained by substituting, adding or deleting one or several amino acids in the amino acid sequence.
[claim4]
4. A pharmaceutical composition, comprising the human antibody kappa type light chain complex-containing composition according to any one of Claims 1 to 3 as an active ingredient.
[claim5]
5. The pharmaceutical composition according to Claim 4, which is an anti-cancer drug.
[claim6]
6. A method of producing a human antibody kappa type light chain complex-containing composition, comprising: an expression process of expressing a human antibody kappa type light chain by an intracellular or extracellular expression system using an expression vector including a polynucleotide encoding the human antibody kappa type light chain having cysteine residue at the C terminal thereof; and a purification process of purifying the human antibody kappa type light chain from the expression product obtained in the expression process, wherein, (a) the human antibody kappa type light chain is expressed in the presence of one or more kinds of metal ions selected from the group consisting of Group 10 elements, Group 11 elements, and Group 12 elements in the expression process, or (b) the human antibody kappa type light chain is purified from a mixture obtained by adding one or more kinds of metal ions selected from the group consisting of Group 10 elements, Group 11 elements, and Group 12 elements to the expression product obtained in the expression process.
[claim7]
7. The method of producing a human antibody kappa type light chain complex-containing composition according to Claim 6,
wherein, in (b), the human antibody kappa type light chain is purified from the mixture after incubating the mixture for 30 minutes to 48 hours.
[claim8]
8. The method of producing a human antibody kappa type light chain complex-containing composition according to Claim 6 or 7,
wherein the purification process includes: a first purification process of obtaining a crude purified product containing the human antibody kappa type light chain from the expression product obtained from the expression process by column chromatography using a column containing a first filler; and a second purification process of obtaining a purified product of the human antibody kappa type light chain from the crude purified product obtained from the first purification process by column chromatography using a column containing a second filler, and wherein the metal ion is added to the crude purified product before the second purification process after the first purification process.
[claim9]
9. The method of producing a human antibody kappa type light chain complex-containing composition according to Claim 8,
wherein, before the second purification process, the crude purified product, to which the metal ion has been added, is incubated for 30 minutes to 48 hours.
[claim10]
10. The method of producing a human antibody kappa type light chain complex-containing composition according to Claim 8 or 9,
wherein the metal ion is added into the expression system in the expression process, and is further added to the crude purified product before the second purification process after the first purification process.
[claim11]
11. A method of producing a human antibody kappa type light chain complex-containing composition,
wherein a human antibody kappa type light chain is incubated in a solution containing one or more kinds of metal ions selected from the group consisting of Group 10 elements, Group 11 elements, and Group 12 elements to produce a composition containing a complex in which cysteine residues at C terminals of two human antibody kappa type light chains are bound to each other via the metal ion.
  • Applicant
  • JAPAN SCIENCE AND TECHNOLOGY AGENCY
  • Inventor
  • UDA TAIZO
  • HIFUMI EMI
IPC(International Patent Classification)
Specified countries (EP3037434)
Contracting States: AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR
Extension States: BA ME
Reference ( R and D project ) CREST Establishment of Innovative Manufacturing Technology Based on Nanoscience AREA
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