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Updated Recommendations for the Bioanalysis of Antibody-Drug Conjugates (ADC) from the ADC working group of the AAPS Bioanalytical Community.

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Title: Updated Recommendations for the Bioanalysis of Antibody-Drug Conjugates (ADC) from the ADC working group of the AAPS Bioanalytical Community.
Authors: Shen JX; Bristol Myers Squibb, Lawrenceville, New Jersey, USA. jim.shen@bms.com., Dodge R; Princeton, New Jersey, USA. rob.dodge22@outlook.com., Oberstein S; Takeda Pharmaceutical Company Limited, Tokyo, Japan., Cunliffe J; Novartis, Cambridge, Massachusetts, USA., Ramani V; Celerion, Lincoln, Nebraska, USA., Mohana Sundaram S; Celerion, Lincoln, Nebraska, USA., Santos IC; Bristol Myers Squibb, Lawrenceville, New Jersey, USA., Yu C; US Food and Drug Administration, Silver Spring, Maryland, USA., Dholakiya SL; Bristol Myers Squibb, Lawrenceville, New Jersey, USA., Kumar S; Pioneering Medicines at Flagship Pioneering Inc., Cambridge, Massachusetts, USA., Xu XS; Daiichi Sankyo Inc., Basking Ridge, New Jersey, USA., Fraser S; Regeneron Pharmaceuticals Inc., Tarrytown, New York, USA., Mokhtari Z; Takeda Pharmaceutical Company Limited, Tokyo, Japan., Yin F; Takeda Pharmaceutical Company Limited, Tokyo, Japan., Rizzo DG; AbbVie Inc., North Chicago, Illinois, USA., Barnaby OS; Thousand Oaks, Amgen, California, USA., Shen H; Merck & Co., Inc., Rahway, New Jersey, USA., Warrino DE; KCAS Bio, Olathe, Kansas, USA., Awasthi S; Merck & Co., Inc., Rahway, New Jersey, USA., Burke K; Johnson & Johnson, New Brunswick, New Jersey, USA., Schaffer S; Johnson & Johnson, New Brunswick, New Jersey, USA., Rathi A; BioAgilytix Boston, Boston, Massachusetts, USA.
Source: The AAPS journal [AAPS J] 2026 Jul 01; Vol. 28 (4). Date of Electronic Publication: 2026 Jul 01.
Publication Type: Journal Article
Journal Info: Publisher: American Association of Pharmaceutical Scientists Country of Publication: United States NLM ID: 101223209 Publication Model: Electronic Cited Medium: Internet ISSN: 1550-7416 (Electronic) Linking ISSN: 15507416 NLM ISO Abbreviation: AAPS J Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Updated Recommendations for the Bioanalysis of Antibody-Drug Conjugates (ADC) from the ADC working group of the AAPS Bioanalytical Community.
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  Data: <searchLink fieldCode="AU" term="%22Shen+JX%22">Shen JX</searchLink>; Bristol Myers Squibb, Lawrenceville, New Jersey, USA. jim.shen@bms.com.<br /><searchLink fieldCode="AU" term="%22Dodge+R%22">Dodge R</searchLink>; Princeton, New Jersey, USA. rob.dodge22@outlook.com.<br /><searchLink fieldCode="AU" term="%22Oberstein+S%22">Oberstein S</searchLink>; Takeda Pharmaceutical Company Limited, Tokyo, Japan.<br /><searchLink fieldCode="AU" term="%22Cunliffe+J%22">Cunliffe J</searchLink>; Novartis, Cambridge, Massachusetts, USA.<br /><searchLink fieldCode="AU" term="%22Ramani+V%22">Ramani V</searchLink>; Celerion, Lincoln, Nebraska, USA.<br /><searchLink fieldCode="AU" term="%22Mohana+Sundaram+S%22">Mohana Sundaram S</searchLink>; Celerion, Lincoln, Nebraska, USA.<br /><searchLink fieldCode="AU" term="%22Santos+IC%22">Santos IC</searchLink>; Bristol Myers Squibb, Lawrenceville, New Jersey, USA.<br /><searchLink fieldCode="AU" term="%22Yu+C%22">Yu C</searchLink>; US Food and Drug Administration, Silver Spring, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Dholakiya+SL%22">Dholakiya SL</searchLink>; Bristol Myers Squibb, Lawrenceville, New Jersey, USA.<br /><searchLink fieldCode="AU" term="%22Kumar+S%22">Kumar S</searchLink>; Pioneering Medicines at Flagship Pioneering Inc., Cambridge, Massachusetts, USA.<br /><searchLink fieldCode="AU" term="%22Xu+XS%22">Xu XS</searchLink>; Daiichi Sankyo Inc., Basking Ridge, New Jersey, USA.<br /><searchLink fieldCode="AU" term="%22Fraser+S%22">Fraser S</searchLink>; Regeneron Pharmaceuticals Inc., Tarrytown, New York, USA.<br /><searchLink fieldCode="AU" term="%22Mokhtari+Z%22">Mokhtari Z</searchLink>; Takeda Pharmaceutical Company Limited, Tokyo, Japan.<br /><searchLink fieldCode="AU" term="%22Yin+F%22">Yin F</searchLink>; Takeda Pharmaceutical Company Limited, Tokyo, Japan.<br /><searchLink fieldCode="AU" term="%22Rizzo+DG%22">Rizzo DG</searchLink>; AbbVie Inc., North Chicago, Illinois, USA.<br /><searchLink fieldCode="AU" term="%22Barnaby+OS%22">Barnaby OS</searchLink>; Thousand Oaks, Amgen, California, USA.<br /><searchLink fieldCode="AU" term="%22Shen+H%22">Shen H</searchLink>; Merck & Co., Inc., Rahway, New Jersey, USA.<br /><searchLink fieldCode="AU" term="%22Warrino+DE%22">Warrino DE</searchLink>; KCAS Bio, Olathe, Kansas, USA.<br /><searchLink fieldCode="AU" term="%22Awasthi+S%22">Awasthi S</searchLink>; Merck & Co., Inc., Rahway, New Jersey, USA.<br /><searchLink fieldCode="AU" term="%22Burke+K%22">Burke K</searchLink>; Johnson & Johnson, New Brunswick, New Jersey, USA.<br /><searchLink fieldCode="AU" term="%22Schaffer+S%22">Schaffer S</searchLink>; Johnson & Johnson, New Brunswick, New Jersey, USA.<br /><searchLink fieldCode="AU" term="%22Rathi+A%22">Rathi A</searchLink>; BioAgilytix Boston, Boston, Massachusetts, USA.
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  Data: <searchLink fieldCode="JN" term="%22101223209%22">The AAPS journal</searchLink> [AAPS J] 2026 Jul 01; Vol. 28 (4). <i>Date of Electronic Publication: </i>2026 Jul 01.
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              Text: 2026 Jul 01
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