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In-use physicochemical and microbiological stability of biological parenteral products.
Ricci MS, Frazier M, Moore J, Cromwell M, Galush WJ, Patel AR, Adler M, Altenburger U, Grauschopf U, Goldbach P, Fast JL, Krämer I, Mahler HC. Ricci MS, et al. Among authors: patel ar. Am J Health Syst Pharm. 2015 Mar 1;72(5):396-407. doi: 10.2146/ajhp140098. Am J Health Syst Pharm. 2015. PMID: 25694415 No abstract available.
Stress Temperature Studies in Small Scale Hastelloy® Drug Substance Containers Lead to Increased Extent of and Increased Variability in Antibody-Drug Conjugate and Monoclonal Antibody Aggregation: Evidence for Novel Oxidation-Induced Crosslinking in Monoclonal Antibodies.
Klair N, Kim MT, Lee A, Xiao NJ, Patel AR. Klair N, et al. Among authors: patel ar. J Pharm Sci. 2021 Apr;110(4):1615-1624. doi: 10.1016/j.xphs.2020.09.052. Epub 2020 Oct 7. J Pharm Sci. 2021. PMID: 33035540
A Multicompany Assessment of Submicron Particle Levels by NTA and RMM in a Wide Range of Late-Phase Clinical and Commercial Biotechnology-Derived Protein Products.
Hubert M, Yang DT, Kwok SC, Rios A, Das TK, Patel A, Wuchner K, Antochshuk V, Junge F, Bou-Assaf GM, Cao S, Saggu M, Montrond L, Afonina N, Kolhe P, Loladze V, Narhi L. Hubert M, et al. J Pharm Sci. 2020 Jan;109(1):830-844. doi: 10.1016/j.xphs.2019.10.025. Epub 2019 Oct 21. J Pharm Sci. 2020. PMID: 31647951
795 results