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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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Bibliographic Details
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
Description
ISSN:1520-6017
DOI:10.1016/j.xphs.2022.03.001