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

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Bibliographic Details
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

Description
ISSN:	1520-6017
DOI:	10.1016/j.xphs.2025.104045