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. |
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| 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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