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Recommendation of Single Time Point Leachables Testing for Lyophilized Biotechnology Products Stored in Rubber Stoppered Glass Vial Systems.

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Title: Recommendation of Single Time Point Leachables Testing for Lyophilized Biotechnology Products Stored in Rubber Stoppered Glass Vial Systems.
Authors: Gallegos A; Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, United States. Electronic address: gallegoa@amgen.com., Liu J; Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, United States., Ronk M; Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, United States., Qi L; Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, United States., Li K; Environment, Health, Safety and Sustainability, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, United States., Semin D; Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, United States., Nashed-Samuel Y; Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, United States. Electronic address: snashed@amgen.com.
Source: Journal of pharmaceutical sciences [J Pharm Sci] 2022 Jun; Vol. 111 (6), pp. 1599-1604. Date of Electronic Publication: 2022 Mar 05.
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: Recommendation of Single Time Point Leachables Testing for Lyophilized Biotechnology Products Stored in Rubber Stoppered Glass Vial Systems.
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  Data: <searchLink fieldCode="AU" term="%22Gallegos+A%22">Gallegos A</searchLink>; Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, United States. Electronic address: gallegoa@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, United States.<br /><searchLink fieldCode="AU" term="%22Ronk+M%22">Ronk M</searchLink>; Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, United States.<br /><searchLink fieldCode="AU" term="%22Qi+L%22">Qi L</searchLink>; Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, United States.<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, United States.<br /><searchLink fieldCode="AU" term="%22Semin+D%22">Semin D</searchLink>; Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, United States.<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, United States. Electronic address: snashed@amgen.com.
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  Data: <searchLink fieldCode="JN" term="%222985195R%22">Journal of pharmaceutical sciences</searchLink> [J Pharm Sci] 2022 Jun; Vol. 111 (6), pp. 1599-1604. <i>Date of Electronic Publication: </i>2022 Mar 05.
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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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      – Type: doi
        Value: 10.1016/j.xphs.2022.03.001
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      – Code: eng
        Text: English
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        StartPage: 1599
    Titles:
      – TitleFull: Recommendation of Single Time Point Leachables Testing for Lyophilized Biotechnology Products Stored in Rubber Stoppered Glass Vial Systems.
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            NameFull: Gallegos A
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            NameFull: Liu J
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            NameFull: Ronk M
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            NameFull: Qi L
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            NameFull: Li K
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            NameFull: Semin D
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            – D: 01
              M: 06
              Text: 2022 Jun
              Type: published
              Y: 2022
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