EFFECTIVE METHOD FOR MANUFACTURING ANTIBODY-DRUG CONJUGATE

A method for producing an antibody-drug conjugate in which a drug-linker represented by formula (1) (wherein A represents the connecting position to an antibody) is conjugated to the antibody via a thioether bond, wherein the method comprising the steps of: (i) reducing the antibody with a reducing...

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Bibliographische Detailangaben
Hauptverfasser:	SAKURATANI Kenji, YAMAGUCHI Tatsuya
Format:	Patent
Sprache:	eng ; fre ; ger
Schlagworte:	CHEMISTRY HUMAN NECESSITIES HYGIENE MEDICAL OR VETERINARY SCIENCE METALLURGY ORGANIC CHEMISTRY PEPTIDES PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS ORMEDICINAL PREPARATIONS
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Beschreibung
Zusammenfassung:	A method for producing an antibody-drug conjugate in which a drug-linker represented by formula (1) (wherein A represents the connecting position to an antibody) is conjugated to the antibody via a thioether bond, wherein the method comprising the steps of: (i) reducing the antibody with a reducing agent; (ii) reacting a drug-linker intermediate with the antibody reduced in step (i); (iii) adding a reagent having a thiol group to react with the residual drug-linker intermediate in step (ii); and then (iv) removing by-products derived from the drug-linker intermediate through ultrafiltration using a buffer solution containing a salt consisting of a strong acid and a strong base, and a method for producing a pharmaceutical composition containing the antibody-drug conjugate.