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Association of Immunogenicity and Drug Exposure and the Importance of Target Engagement in ADA Development: A Clinical Case Study of Anti-SARS-CoV-2 Biotherapeutics.

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Title: Association of Immunogenicity and Drug Exposure and the Importance of Target Engagement in ADA Development: A Clinical Case Study of Anti-SARS-CoV-2 Biotherapeutics.
Authors: Irvin SC; Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA. susan.irvin@regeneron.com., Ganguly S; Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA., Wang Z; Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA., He ZW; Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA., Alejandro M; Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA., Donohue K; Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA., Elango C; Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA., Gallo C; Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA., Guttmann S; Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA., Kalicharan S; Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA., Kameron K; Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA., Laird J; Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA., Laurino K; Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA., Trotter H; Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA., Rodriguez J; Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA., Santiago K; Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA., Speaks E; Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA., Sumner G; Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA., Andisik MD; Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA., Yan H; Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA., Turner KC; Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA., Davis JD; Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA., Partridge MA; Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA.
Source: The AAPS journal [AAPS J] 2025 Oct 23; Vol. 28 (1), pp. 2. Date of Electronic Publication: 2025 Oct 23.
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
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  Data: <searchLink fieldCode="AU" term="%22Irvin+SC%22">Irvin SC</searchLink>; Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA. susan.irvin@regeneron.com.<br /><searchLink fieldCode="AU" term="%22Ganguly+S%22">Ganguly S</searchLink>; Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA.<br /><searchLink fieldCode="AU" term="%22Wang+Z%22">Wang Z</searchLink>; Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA.<br /><searchLink fieldCode="AU" term="%22He+ZW%22">He ZW</searchLink>; Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA.<br /><searchLink fieldCode="AU" term="%22Alejandro+M%22">Alejandro M</searchLink>; Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA.<br /><searchLink fieldCode="AU" term="%22Donohue+K%22">Donohue K</searchLink>; Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA.<br /><searchLink fieldCode="AU" term="%22Elango+C%22">Elango C</searchLink>; Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA.<br /><searchLink fieldCode="AU" term="%22Gallo+C%22">Gallo C</searchLink>; Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA.<br /><searchLink fieldCode="AU" term="%22Guttmann+S%22">Guttmann S</searchLink>; Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA.<br /><searchLink fieldCode="AU" term="%22Kalicharan+S%22">Kalicharan S</searchLink>; Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA.<br /><searchLink fieldCode="AU" term="%22Kameron+K%22">Kameron K</searchLink>; Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA.<br /><searchLink fieldCode="AU" term="%22Laird+J%22">Laird J</searchLink>; Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA.<br /><searchLink fieldCode="AU" term="%22Laurino+K%22">Laurino K</searchLink>; Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA.<br /><searchLink fieldCode="AU" term="%22Trotter+H%22">Trotter H</searchLink>; Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA.<br /><searchLink fieldCode="AU" term="%22Rodriguez+J%22">Rodriguez J</searchLink>; Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA.<br /><searchLink fieldCode="AU" term="%22Santiago+K%22">Santiago K</searchLink>; Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA.<br /><searchLink fieldCode="AU" term="%22Speaks+E%22">Speaks E</searchLink>; Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA.<br /><searchLink fieldCode="AU" term="%22Sumner+G%22">Sumner G</searchLink>; Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA.<br /><searchLink fieldCode="AU" term="%22Andisik+MD%22">Andisik MD</searchLink>; Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA.<br /><searchLink fieldCode="AU" term="%22Yan+H%22">Yan H</searchLink>; Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA.<br /><searchLink fieldCode="AU" term="%22Turner+KC%22">Turner KC</searchLink>; Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA.<br /><searchLink fieldCode="AU" term="%22Davis+JD%22">Davis JD</searchLink>; Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA.<br /><searchLink fieldCode="AU" term="%22Partridge+MA%22">Partridge MA</searchLink>; Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA.
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