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A Holistic Approach of Extractables and Leachables Assessment of Rubber Stoppered Glass Vial Systems for Biotechnology Products.

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Title: A Holistic Approach of Extractables and Leachables Assessment of Rubber Stoppered Glass Vial Systems for Biotechnology Products.
Authors: Qi L; Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320. Electronic address: lqi@amgen.com., Liu J; Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320., Ronk M; Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320., Gallegos A; Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320., Fujimori K; Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320., Luo Y; Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320., Li K; Environment, Health, Safety and Sustainability, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320., Lee H; Los Angeles Trade-Technical College, 400 West Washington Blvd, Los Angeles, CA 90015., Nashed-Samuel Y; Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320. Electronic address: snashed@amgen.com.
Source: Journal of pharmaceutical sciences [J Pharm Sci] 2021 Nov; Vol. 110 (11), pp. 3580-3593. Date of Electronic Publication: 2021 Jul 27.
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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PubType: Academic Journal
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  Data: A Holistic Approach of Extractables and Leachables Assessment of Rubber Stoppered Glass Vial Systems for Biotechnology Products.
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  Data: <searchLink fieldCode="AU" term="%22Qi+L%22">Qi L</searchLink>; Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320. Electronic address: lqi@amgen.com.<br /><searchLink fieldCode="AU" term="%22Liu+J%22">Liu J</searchLink>; Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320.<br /><searchLink fieldCode="AU" term="%22Ronk+M%22">Ronk M</searchLink>; Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320.<br /><searchLink fieldCode="AU" term="%22Gallegos+A%22">Gallegos A</searchLink>; Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320.<br /><searchLink fieldCode="AU" term="%22Fujimori+K%22">Fujimori K</searchLink>; Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320.<br /><searchLink fieldCode="AU" term="%22Luo+Y%22">Luo Y</searchLink>; Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320.<br /><searchLink fieldCode="AU" term="%22Li+K%22">Li K</searchLink>; Environment, Health, Safety and Sustainability, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320.<br /><searchLink fieldCode="AU" term="%22Lee+H%22">Lee H</searchLink>; Los Angeles Trade-Technical College, 400 West Washington Blvd, Los Angeles, CA 90015.<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. Electronic address: snashed@amgen.com.
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        Value: 10.1016/j.xphs.2021.07.015
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        Text: English
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        StartPage: 3580
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      – TitleFull: A Holistic Approach of Extractables and Leachables Assessment of Rubber Stoppered Glass Vial Systems for Biotechnology Products.
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            NameFull: Qi L
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              Text: 2021 Nov
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