Similar articles for PMID: 27325598

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1

A Small-scale Model to Assess the Risk of Leachables from Single-use Bioprocess Containers through Protein Quality Characterization.

Xiao NJ, Medley CD, Shieh IC, Downing G, Pizarro S, Liu J, Patel AR. Xiao NJ, et al. PDA J Pharm Sci Technol. 2016 11/12;70(6):533-546. doi: 10.5731/pdajpst.2015.006338. Epub 2016 Jun 20. PDA J Pharm Sci Technol. 2016. PMID: 27325598

2

Comparative Leachable Study of Glass Vials to Demonstrate the Impact of Low Fill Volume.

Hladik B, Buscke F, Frost R, Rothhaar U. Hladik B, et al. PDA J Pharm Sci Technol. 2019 Jul-Aug;73(4):345-355. doi: 10.5731/pdajpst.2018.009472. Epub 2019 Feb 15. PDA J Pharm Sci Technol. 2019. PMID: 30770482

3

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

Gallegos A, Liu J, Ronk M, Qi L, Li K, Semin D, Nashed-Samuel Y. Gallegos A, et al. J Pharm Sci. 2022 Jun;111(6):1599-1604. doi: 10.1016/j.xphs.2022.03.001. Epub 2022 Mar 5. J Pharm Sci. 2022. PMID: 35257694

4

Effects of surfaces and leachables on the stability of biopharmaceuticals.

Bee JS, Randolph TW, Carpenter JF, Bishop SM, Dimitrova MN. Bee JS, et al. J Pharm Sci. 2011 Oct;100(10):4158-70. doi: 10.1002/jps.22597. Epub 2011 Apr 26. J Pharm Sci. 2011. PMID: 21523787 Review.

5

Creating a Holistic Extractables and Leachables (E&L) Program for Biotechnology Products.

Li K, Rogers G, Nashed-Samuel Y, Lee H, Mire-Sluis A, Cherney B, Forster R, Yeh P, Markovic I. Li K, et al. PDA J Pharm Sci Technol. 2015 Sep-Oct;69(5):590-619. doi: 10.5731/pdajpst.2015.01073. PDA J Pharm Sci Technol. 2015. PMID: 26429108

6

Introducing the Alba^® Primary Packaging Platform. Part 1: Particle Release Evaluation.

Chillon A, Pace A, Zuccato D. Chillon A, et al. PDA J Pharm Sci Technol. 2018 Jul-Aug;72(4):382-392. doi: 10.5731/pdajpst.2018.008623. Epub 2018 May 31. PDA J Pharm Sci Technol. 2018. PMID: 29853611

7

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. 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

8

Prolonged In-use Stability of Diluted Atezolizumab in Commercial Intravenous Bags.

Hui A, Yin J, Liu W, Zheng K. Hui A, et al. Int J Pharm Compd. 2021 May-Jun;25(3):246-257. Int J Pharm Compd. 2021. PMID: 34125716

9

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

Qi L, Liu J, Ronk M, Gallegos A, Fujimori K, Luo Y, Li K, Lee H, Nashed-Samuel Y. Qi L, et al. J Pharm Sci. 2021 Nov;110(11):3580-3593. doi: 10.1016/j.xphs.2021.07.015. Epub 2021 Jul 27. J Pharm Sci. 2021. PMID: 34324943

10

Container/Closure Integrity Testing and the Identification of a Suitable Vial/Stopper Combination for Low-Temperature Storage at -80 {degrees}C.

Zuleger B, Werner U, Kort A, Glowienka R, Wehnes E, Duncan D. Zuleger B, et al. PDA J Pharm Sci Technol. 2012 Sep-Oct;66(5):453-65. doi: 10.5731/pdajpst.2012.00884. PDA J Pharm Sci Technol. 2012. PMID: 23035029

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