METHODS FOR FORMULATING ANTIBODY DRUG CONJUGATE COMPOSITIONS

To provide methods for formulating antibody drug conjugate compositions.SOLUTION: The present invention provides improved methods for formulating therapeutic compositions comprising an antibody drug conjugate ("ADC"), which reduce potency variability between batches of the ADC and provide...

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Bibliographische Detailangaben
Hauptverfasser:	GILLIAN PAYNE, JUMA BRIDGEWATER, ROBERT W HERBST
Format:	Patent
Sprache:	eng ; jpn
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:	To provide methods for formulating antibody drug conjugate compositions.SOLUTION: The present invention provides improved methods for formulating therapeutic compositions comprising an antibody drug conjugate ("ADC"), which reduce potency variability between batches of the ADC and provide administration of such therapeutic compositions within a narrow intended range. The present invention provides a novel method for formulating a therapeutic composition comprising an antibody drug conjugate ("ADC") based on the drug concentration, thereby narrowing the variability in potency between batches of the ADC, and minimizing toxicity and increasing the efficacy of a drug formulated according to the method.SELECTED DRAWING: Figure 1 【課題】抗体薬物複合体組成物の製剤化方法の提供。【解決手段】本発明は、ＡＤＣのバッチ間で効力変動性を低下させ、意図する狭い範囲内でそのような治療用組成物を投与することを提供する、抗体薬物複合体（「ＡＤＣ」）を含む治療用組成物を製剤化するための改善された方法を提供する。本発明は、薬物濃度に基づいて抗体薬物複合体（「ＡＤＣ」）を含む治療用組成物を製剤化することによって、ＡＤＣのバッチ間で効力の変動性を狭め、本方法に従って製剤化された薬物の毒性を最小限にし、その有効性を増加させるための新規の方法を提供する。【選択図】図１