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Discoloration source and control of a biotechnological drug product manufactured using a high titer production process.

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Title: Discoloration source and control of a biotechnological drug product manufactured using a high titer production process.
Authors: Liu J; Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA. Electronic address: jialiu@amgen.com., Zhang Z; Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA., Polozova A; Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA., Chan B; Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA., Savjani N; Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA., Wypych J; Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA., Yu Rice Y; Environment, Health, Safety and Sustainability, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA., Bondarenko PV; Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA., Semin DJ; Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA., Nashed-Samuel Y; Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA. Electronic address: snashed@amgen.com.
Source: Journal of pharmaceutical sciences [J Pharm Sci] 2026 Jan; Vol. 115 (1), pp. 104045. Date of Electronic Publication: 2025 Oct 28.
Publication Type: Journal Article
Journal Info: Publisher: Elsevier Country of Publication: United States NLM ID: 2985195R Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1520-6017 (Electronic) Linking ISSN: 00223549 NLM ISO Abbreviation: J Pharm Sci Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Discoloration source and control of a biotechnological drug product manufactured using a high titer production process.
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  Data: <searchLink fieldCode="AU" term="%22Liu+J%22">Liu J</searchLink>; Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA. Electronic address: jialiu@amgen.com.<br /><searchLink fieldCode="AU" term="%22Zhang+Z%22">Zhang Z</searchLink>; Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA.<br /><searchLink fieldCode="AU" term="%22Polozova+A%22">Polozova A</searchLink>; Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA.<br /><searchLink fieldCode="AU" term="%22Chan+B%22">Chan B</searchLink>; Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA.<br /><searchLink fieldCode="AU" term="%22Savjani+N%22">Savjani N</searchLink>; Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA.<br /><searchLink fieldCode="AU" term="%22Wypych+J%22">Wypych J</searchLink>; Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA.<br /><searchLink fieldCode="AU" term="%22Yu+Rice+Y%22">Yu Rice Y</searchLink>; Environment, Health, Safety and Sustainability, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA.<br /><searchLink fieldCode="AU" term="%22Bondarenko+PV%22">Bondarenko PV</searchLink>; Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA.<br /><searchLink fieldCode="AU" term="%22Semin+DJ%22">Semin DJ</searchLink>; Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA.<br /><searchLink fieldCode="AU" term="%22Nashed-Samuel+Y%22">Nashed-Samuel Y</searchLink>; Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA. Electronic address: snashed@amgen.com.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Elsevier%22">Elsevier </searchLink><i>Country of Publication: </i>United States <i>NLM ID: </i>2985195R <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1520-6017 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2200223549%22">00223549 </searchLink><i>NLM ISO Abbreviation: </i>J Pharm Sci <i>Subsets: </i>MEDLINE
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        Value: 10.1016/j.xphs.2025.104045
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        Text: English
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        StartPage: 104045
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              Text: 2026 Jan
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