Similar articles for PMID: 20088246

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1

Extractables from integrated single-use systems in biopharmaceutical manufacturing. Part I. Study on components (Pall Kleenpak connector and Kleenpak filter capsule).

Ding W, Nash R. Ding W, et al. PDA J Pharm Sci Technol. 2009 Jul-Aug;63(4):322-38. PDA J Pharm Sci Technol. 2009. PMID: 20088246

2

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

3

Using Extractables Data of Sterile Filter Components for Scaling Calculations.

Pahl I, Menzel R, Hauk A, Loewe T. Pahl I, et al. PDA J Pharm Sci Technol. 2019 Nov-Dec;73(6):523-537. doi: 10.5731/pdajpst.2018.009647. Epub 2019 May 17. PDA J Pharm Sci Technol. 2019. PMID: 31101707

4

Extractables analysis of single-use flexible plastic biocontainers.

Marghitoiu L, Liu J, Lee H, Perez L, Fujimori K, Ronk M, Hammond MR, Nunn H, Lower A, Rogers G, Nashed-Samuel Y. Marghitoiu L, et al. PDA J Pharm Sci Technol. 2015 Jan-Feb;69(1):49-58. doi: 10.5731/pdajpst.2015.01001. PDA J Pharm Sci Technol. 2015. PMID: 25691714

5

Equipment and analytical companies meeting continuous challenges. May 20-21, 2014 Continuous Manufacturing Symposium.

Page T, Dubina H, Fillipi G, Guidat R, Patnaik S, Poechlauer P, Shering P, Guinn M, Mcdonnell P, Johnston C. Page T, et al. J Pharm Sci. 2015 Mar;104(3):821-31. doi: 10.1002/jps.24282. Epub 2014 Dec 1. J Pharm Sci. 2015. PMID: 25448273 Review.

6

Analysis and evaluation of filter cartridge extractables for validation in pharmaceutical downstream processing.

Reif OW, Sölkner P, Rupp J. Reif OW, et al. PDA J Pharm Sci Technol. 1996 Nov-Dec;50(6):399-410. PDA J Pharm Sci Technol. 1996. PMID: 9038087

7

Analysis and evaluation of single-use bag extractables for validation in biopharmaceutical applications.

Pahl I, Dorey S, Barbaroux M, Lagrange B, Frankl H. Pahl I, et al. PDA J Pharm Sci Technol. 2014 Sep-Oct;68(5):456-71. doi: 10.5731/pdajpst.2014.00996. PDA J Pharm Sci Technol. 2014. PMID: 25336417

8

Qualitative assessment of extractables from single-use components and the impact of reference standard selection.

Jordi MA, Khera S, Roland K, Jiang L, Solomon P, Nelson J, Lateef SS, Woods J, Martin L, Martin S, Aiello F, Chen N. Jordi MA, et al. J Pharm Biomed Anal. 2018 Feb 20;150:368-376. doi: 10.1016/j.jpba.2017.12.029. Epub 2017 Dec 19. J Pharm Biomed Anal. 2018. PMID: 29287264

9

On developing a process for conducting extractable-leachable assessment of components used for storage of biopharmaceuticals.

Wakankar AA, Wang YJ, Canova-Davis E, Ma S, Schmalzing D, Grieco J, Milby T, Reynolds T, Mazzarella K, Hoff E, Gomez S, Martin-Moe S. Wakankar AA, et al. J Pharm Sci. 2010 May;99(5):2209-18. doi: 10.1002/jps.22012. J Pharm Sci. 2010. PMID: 20039383 Review.

10

Throughput Optimization of Continuous Biopharmaceutical Manufacturing Facilities.

Garcia FA, Vandiver MW. Garcia FA, et al. PDA J Pharm Sci Technol. 2017 May-Jun;71(3):189-205. doi: 10.5731/pdajpst.2016.006882. Epub 2016 Dec 14. PDA J Pharm Sci Technol. 2017. PMID: 27974629

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