Similar articles for PMID: 30030349

Year	Number of Results
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2001	6
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2011	6
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2013	14
2014	19
2015	18
2016	20
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2018	36
2019	48
2020	52
2021	44
2022	52
2023	17
2024	0

1

Multiproduct Resin Reuse for Clinical and Commercial Manufacturing-Methodology and Acceptance Criteria.

Sharnez R, Doares S, Manning S, Mehta K, Mahajan E, To A, Daniels W, Glynn J, Dhamane S, Wen X, Wang Y, Gour P, Guenther C, Foley D, Hayes R, Mott A, Prabhu S, Tavalsky D, Hendershot M, Haas D, Hesslein A, Schuelke N, Tjandra H. Sharnez R, et al. PDA J Pharm Sci Technol. 2018 Nov-Dec;72(6):584-598. doi: 10.5731/pdajpst.2016.007245. Epub 2018 Jul 20. PDA J Pharm Sci Technol. 2018. PMID: 30030349

2

Evaluating multiproduct chromatography Protein A resin reuse for monoclonal antibodies in biopharmaceutical manufacturing.

Ravi N, Huerta J, Ferreira G. Ravi N, et al. Biotechnol Prog. 2023 May-Jun;39(3):e3333. doi: 10.1002/btpr.3333. Epub 2023 Mar 13. Biotechnol Prog. 2023. PMID: 36795072 Review.

3

Retrospective Evaluation of Cycled Resin in Viral Clearance Studies-A Multiple Company Collaboration.

Mattila J, Curtis S, Webb-Vargas Y, Wilson E, Galperina O, Roush D, Tobler S, Stanley B, Clark M, Weaver J, Pike J, Yu D, Li X, Flicker A, Kindermann J, Schuelke N, Whitcombe R, Bennett L. Mattila J, et al. PDA J Pharm Sci Technol. 2019 Sep-Oct;73(5):470-486. doi: 10.5731/pdajpst.2018.009605. Epub 2019 May 17. PDA J Pharm Sci Technol. 2019. PMID: 31101706

4

Biopharmaceutical Industry Approaches to Facility Segregation for Viral Safety: An Effort from the Consortium on Adventitious Agent Contamination in Biomanufacturing.

Barone PW, Avgerinos S, Ballard R, Brussel A, Clark P, Dowd C, Gerentes L, Hart I, Keumurian FJ, Kindermann J, Leung JC, Ly N, Mink S, Minning S, Mullberg J, Murphy M, Nöske K, Parriott S, Shum B, Wiebe ME, Springs SL. Barone PW, et al. PDA J Pharm Sci Technol. 2019 Mar-Apr;73(2):191-203. doi: 10.5731/pdajpst.2018.008862. Epub 2018 Oct 25. PDA J Pharm Sci Technol. 2019. PMID: 30361281

5

Determining the Clearance of Degraded Protein via a Monoclonal Antibody Purification Process in Support of Cleaning Carryover Limits in Multiproduct Facilities.

Che PL, Bailey AP, Tam CYJ, Alvarez M, Arroyo AY. Che PL, et al. PDA J Pharm Sci Technol. 2020 Jul-Aug;74(4):377-393. doi: 10.5731/pdajpst.2019.010611. Epub 2020 Mar 16. PDA J Pharm Sci Technol. 2020. PMID: 32179711

6

A safe, effective, and facility compatible cleaning in place procedure for affinity resin in large-scale monoclonal antibody purification.

Wang L, Dembecki J, Jaffe NE, O'Mara BW, Cai H, Sparks CN, Zhang J, Laino SG, Russell RJ, Wang M. Wang L, et al. J Chromatogr A. 2013 Sep 20;1308:86-95. doi: 10.1016/j.chroma.2013.07.096. Epub 2013 Aug 1. J Chromatogr A. 2013. PMID: 23953712

7

An enhanced regeneration strategy to improve microbial control and prolong resin lifetime for Protein A resin in large-scale monoclonal antibody (mAb) purification.

Zhou T, Wang L, Zhang Z, Jin M. Zhou T, et al. J Biotechnol. 2019 Jan 10;289:118-125. doi: 10.1016/j.jbiotec.2018.11.022. Epub 2018 Nov 28. J Biotechnol. 2019. PMID: 30502366

8

Exploring features in chromatographic profiles as a tool for monitoring column performance.

Ravi N, Malmquist G, Stanev V, Ferreira G. Ravi N, et al. J Chromatogr A. 2023 Jun 7;1698:463982. doi: 10.1016/j.chroma.2023.463982. Epub 2023 Apr 7. J Chromatogr A. 2023. PMID: 37087858 Free article.

9

The regulatory framework for preventing cross-contamination of pharmaceutical products: History and considerations for the future.

Sargent EV, Flueckiger A, Barle EL, Luo W, Molnar LR, Sandhu R, Weideman PA. Sargent EV, et al. Regul Toxicol Pharmacol. 2016 Aug;79 Suppl 1:S3-S10. doi: 10.1016/j.yrtph.2016.05.029. Epub 2016 May 24. Regul Toxicol Pharmacol. 2016. PMID: 27230736 Review.

10

Vapor Phase Hydrogen Peroxide Decontamination or Sanitization of an Isolator for Aseptic Filling of Monoclonal Antibody Drug Product-Hydrogen Peroxide Uptake and Impact on Protein Quality.

Hubbard A, Roedl T, Hui A, Knueppel S, Eppler K, Lehnert S, Maa YF. Hubbard A, et al. PDA J Pharm Sci Technol. 2018 Jul-Aug;72(4):348-366. doi: 10.5731/pdajpst.2017.008326. Epub 2018 Mar 15. PDA J Pharm Sci Technol. 2018. PMID: 29545321

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