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Items: 1 to 50 of 127

1.

The ELISA Detectability and Potency of Pegfilgrastim Decrease in Physiological Conditions: Key Roles for Aggregation and Individual Variability.

Xie T, Fang H, Ouyang W, Angart P, Chiang MJ, Bhirde AA, Sheikh F, Lynch P, Shah AB, Patil SM, Chen K, Shen M, Agarabi C, Donnelly RP, Brorson K, Schrieber SJ, Howard KE, Rogstad SM, Frucht DM.

Sci Rep. 2020 Feb 12;10(1):2476. doi: 10.1038/s41598-020-59346-z.

2.

Multi-Attribute Method for Quality Control of Therapeutic Proteins.

Rogstad S, Yan H, Wang X, Powers D, Brorson K, Damdinsuren B, Lee S.

Anal Chem. 2019 Nov 19;91(22):14170-14177. doi: 10.1021/acs.analchem.9b03808. Epub 2019 Nov 4.

PMID:
31618017
3.

Mycoplasma Clearance and Risk Analysis in a Model Bioprocess: Robustness with Respect to Mycoplasma Species.

Faison T, Wang J, Johnson S, Brown M, Chiang MJ, Dolan S, Breuning C, Velugula-Yellela SR, Lute S, Fratz-Berilla EJ, Brorson K.

PDA J Pharm Sci Technol. 2019 Sep 13. pii: pdajpst.2018.009613. doi: 10.5731/pdajpst.2018.009613. [Epub ahead of print]

PMID:
31519782
4.

Impacts of intentional mycoplasma contamination on CHO cell bioreactor cultures.

Fratz-Berilla EJ, Faison T, Kohnhorst CL, Velugula-Yellela SR, Powers DN, Brorson K, Agarabi C.

Biotechnol Bioeng. 2019 Dec;116(12):3242-3252. doi: 10.1002/bit.27161. Epub 2019 Sep 11.

5.

Validation and optimization of viral clearance in a downstream continuous chromatography setting.

Chiang MJ, Pagkaliwangan M, Lute S, Bolton G, Brorson K, Schofield M.

Biotechnol Bioeng. 2019 Sep;116(9):2292-2302. doi: 10.1002/bit.27023. Epub 2019 Jun 24.

PMID:
31112283
6.

The Current Scientific and Regulatory Landscape in Advancing Integrated Continuous Biopharmaceutical Manufacturing.

Fisher AC, Kamga MH, Agarabi C, Brorson K, Lee SL, Yoon S.

Trends Biotechnol. 2019 Mar;37(3):253-267. doi: 10.1016/j.tibtech.2018.08.008. Epub 2018 Sep 18. Review.

PMID:
30241924
7.

An ICP-MS platform for metal content assessment of cell culture media and evaluation of spikes in metal concentration on the quality of an IgG3:κ monoclonal antibody during production.

Mohammad A, Agarabi C, Rogstad S, DiCioccio E, Brorson K, Ashraf M, Faustino PJ, Madhavarao CN.

J Pharm Biomed Anal. 2019 Jan 5;162:91-100. doi: 10.1016/j.jpba.2018.09.008. Epub 2018 Sep 10.

PMID:
30227357
8.

Farewell and Thanks!

Brorson K, Junker B, Moreira A, Rathore A, Ricci M, Rao G.

PDA J Pharm Sci Technol. 2018 May-Jun;72(3):222. doi: 10.5731/pdajpst.2018.001107. No abstract available.

PMID:
29915145
9.

High-Throughput In-Use and Stress Size Stability Screening of Protein Therapeutics Using Algorithm-Driven Dynamic Light Scattering.

Bhirde AA, Chiang MJ, Venna R, Beaucage S, Brorson K.

J Pharm Sci. 2018 Aug;107(8):2055-2062. doi: 10.1016/j.xphs.2018.04.017. Epub 2018 Apr 30.

PMID:
29715479
10.

Defining the mechanistic binding of viral particles to a multi-modal anion exchange resin.

Brown MR, Burnham MS, Lute SC, Johnson SA, Walsh AA, Brorson KA, Roush DJ.

Biotechnol Prog. 2018 Jul;34(4):1019-1026. doi: 10.1002/btpr.2648. Epub 2018 Jul 5.

PMID:
29708638
11.

Metabolic responses and pathway changes of mammalian cells under different culture conditions with media supplementations.

Park SY, Reimonn TM, Agarabi CD, Brorson KA, Yoon S.

Biotechnol Prog. 2018 May;34(3):793-805. doi: 10.1002/btpr.2623. Epub 2018 Mar 8.

PMID:
29464928
12.

Evaluating the effect of in-process material on the binding mechanisms of surrogate viral particles to a multi-modal anion exchange resin.

Brown MR, Burnham MS, Johnson SA, Lute SC, Brorson KA, Roush DJ.

J Biotechnol. 2018 Feb 10;267:29-35. doi: 10.1016/j.jbiotec.2017.12.018. Epub 2017 Dec 24.

PMID:
29278725
13.

Comparison of purification strategies for antibodies used in a broad spectrum host cell protein immunoassay.

Baldus PA, Brown M, Wright RS, Campbell JA, Lute S, Chavez B, Brorson K, Mozier N.

Biotechnol Bioeng. 2018 Feb;115(2):413-422. doi: 10.1002/bit.26482. Epub 2017 Nov 22.

PMID:
29064563
14.

Trans-acting oligodeoxythymidine phosphorothioate triester reagents for transient transfection optimized and facilitated by a high-throughput microbioreactor system.

Hsu CJ, Jain HV, Williams A, Wang J, Lute SC, Beaucage SL, Brorson KA.

Biotechnol Appl Biochem. 2018 May;65(3):467-475. doi: 10.1002/bab.1620. Epub 2017 Dec 26.

PMID:
29023997
15.

The step-wise framework to design a chromatography-based hydrophobicity assay for viral particles.

Johnson SA, Walsh A, Brown MR, Lute SC, Roush DJ, Burnham MS, Brorson KA.

J Chromatogr B Analyt Technol Biomed Life Sci. 2017 Sep 1;1061-1062:430-437. doi: 10.1016/j.jchromb.2017.08.002. Epub 2017 Aug 9.

PMID:
28818800
16.

Adapting viral safety assurance strategies to continuous processing of biological products.

Johnson SA, Brown MR, Lute SC, Brorson KA.

Biotechnol Bioeng. 2017 Jun;114(6):1362. doi: 10.1002/bit.26245. No abstract available.

PMID:
28425635
17.

Emerging Technology as a Key Enabler for Modernizing Pharmaceutical Manufacturing.

Lee SL, Brorson K.

PDA J Pharm Sci Technol. 2017 Mar-Apr;71(2):66-67. doi: 10.5731/pdajpst.2017.001100. No abstract available.

PMID:
28396563
18.

Characterization of Non-Infectious Virus-Like Particle Surrogates for Viral Clearance Applications.

Johnson S, Brorson KA, Frey DD, Dhar AK, Cetlin DA.

Appl Biochem Biotechnol. 2017 Sep;183(1):318-331. doi: 10.1007/s12010-017-2447-y. Epub 2017 Mar 9.

PMID:
28281181
19.

Automated 2D-HPLC method for characterization of protein aggregation with in-line fraction collection device.

Williams A, Read EK, Agarabi CD, Lute S, Brorson KA.

J Chromatogr B Analyt Technol Biomed Life Sci. 2017 Mar 1;1046:122-130. doi: 10.1016/j.jchromb.2017.01.021. Epub 2017 Jan 25.

PMID:
28178596
20.

A step-wise approach to define binding mechanisms of surrogate viral particles to multi-modal anion exchange resin in a single solute system.

Brown MR, Johnson SA, Brorson KA, Lute SC, Roush DJ.

Biotechnol Bioeng. 2017 Jul;114(7):1487-1494. doi: 10.1002/bit.26251. Epub 2017 Mar 6.

PMID:
28109126
21.

Mycoplasma Clearance and Risk Analysis in a Model Bioprocess.

Wang J, Johnson S, Brown M, Lute S, Agarabi C, Dabrazhynetskaya A, Chizhikov V, Brorson K.

PDA J Pharm Sci Technol. 2017 Mar-Apr;71(2):99-114. doi: 10.5731/pdajpst.2016.007054. Epub 2017 Jan 15.

PMID:
28089962
22.

Exploring the linkage between cell culture process parameters and downstream processing utilizing a plackett-burman design for a model monoclonal antibody.

Agarabi CD, Chavez BK, Lute SC, Read EK, Rogstad S, Awotwe-Otoo D, Brown MR, Boyne MT 2nd, Brorson KA.

Biotechnol Prog. 2017 Jan;33(1):163-170. doi: 10.1002/btpr.2402. Epub 2016 Nov 21.

PMID:
27813291
23.

Hybridoma cell-culture and glycan profile dataset at various bioreactor conditions.

Bhatia H, Read E, Agarabi C, Brorson K, Lute S, Yoon S.

Data Brief. 2016 Oct 13;9:676-678. eCollection 2016 Dec.

24.
25.

A design space exploration for control of Critical Quality Attributes of mAb.

Bhatia H, Read E, Agarabi C, Brorson K, Lute S, Yoon S.

Int J Pharm. 2016 Oct 15;512(1):242-252. doi: 10.1016/j.ijpharm.2016.08.046. Epub 2016 Aug 27.

PMID:
27575657
26.

Session 2: Company-Specific Data on Cycled Resin Testing.

Blümel J, Brorson K.

PDA J Pharm Sci Technol. 2016 Sep 10;70(5):428-442. Epub 2016 Aug 11. No abstract available.

PMID:
27516483
27.

Adapting viral safety assurance strategies to continuous processing of biological products.

Johnson SA, Brown MR, Lute SC, Brorson KA.

Biotechnol Bioeng. 2017 Jan;114(1):21-32. doi: 10.1002/bit.26060. Epub 2016 Aug 17. Review. Erratum in: Biotechnol Bioeng. 2017 Jun;114(6):1362.

PMID:
27474890
28.

Simple NMR methods for evaluating higher order structures of monoclonal antibody therapeutics with quinary structure.

Chen K, Long DS, Lute SC, Levy MJ, Brorson KA, Keire DA.

J Pharm Biomed Anal. 2016 Sep 5;128:398-407. doi: 10.1016/j.jpba.2016.06.007. Epub 2016 Jun 7.

29.

Mechanistic failure mode investigation and resolution of parvovirus retentive filters.

LaCasse D, Lute S, Fiadeiro M, Basha J, Stork M, Brorson K, Godavarti R, Gallo C.

Biotechnol Prog. 2016 Jul 8;32(4):959-70. doi: 10.1002/btpr.2298. Epub 2016 Jun 3.

PMID:
27160325
30.

PDA/FDA Virus & TSE Safety Conference.

Brorson K.

PDA J Pharm Sci Technol. 2016 Mar-Apr;70(2):93. doi: 10.5731/pdajpst.2016.001095. No abstract available.

PMID:
27081149
31.

Improved Stability of a Model IgG3 by DoE-Based Evaluation of Buffer Formulations.

Chavez BK, Agarabi CD, Read EK, Boyne MT 2nd, Khan MA, Brorson KA.

Biomed Res Int. 2016;2016:2074149. doi: 10.1155/2016/2074149. Epub 2016 Mar 3.

32.

Meeting Report: 2015 PDA Virus & TSE Safety Forum.

Willkommen H, Blümel J, Brorson K, Chen D, Chen Q, Gröner A, Kreil TR, Ruffing M, Ruiz S, Scott D, Silvester G.

PDA J Pharm Sci Technol. 2016 Mar-Apr;70(2):177-88. doi: 10.5731/pdajpst.2016.006569. Epub 2016 Mar 28.

PMID:
27020643
33.

N-Glycosylation Design and Control of Therapeutic Monoclonal Antibodies.

Sha S, Agarabi C, Brorson K, Lee DY, Yoon S.

Trends Biotechnol. 2016 Oct;34(10):835-846. doi: 10.1016/j.tibtech.2016.02.013. Epub 2016 Mar 22. Review.

PMID:
27016033
34.

Fermentanomics: Relating quality attributes of a monoclonal antibody to cell culture process variables and raw materials using multivariate data analysis.

Rathore AS, Kumar Singh S, Pathak M, Read EK, Brorson KA, Agarabi CD, Khan M.

Biotechnol Prog. 2015 Nov-Dec;31(6):1586-99. doi: 10.1002/btpr.2155. Epub 2015 Aug 31.

PMID:
26280800
35.

Product and process understanding to relate the effect of freezing method on glycation and aggregation of lyophilized monoclonal antibody formulations.

Awotwe-Otoo D, Agarabi C, Read EK, Lute S, Brorson KA, Khan MA.

Int J Pharm. 2015 Jul 25;490(1-2):341-50. doi: 10.1016/j.ijpharm.2015.03.056. Epub 2015 Mar 30.

PMID:
25835267
36.

Development of a modular virus clearance package for anion exchange chromatography operated in weak partitioning mode.

Iskra T, Sacramo A, Gallo C, Godavarti R, Chen S, Lute S, Brorson K.

Biotechnol Prog. 2015 May-Jun;31(3):750-7. doi: 10.1002/btpr.2080. Epub 2015 Apr 15.

PMID:
25826186
37.

Bioreactor process parameter screening utilizing a Plackett-Burman design for a model monoclonal antibody.

Agarabi CD, Schiel JE, Lute SC, Chavez BK, Boyne MT 2nd, Brorson KA, Khan M, Read EK.

J Pharm Sci. 2015 Jun;104(6):1919-1928. doi: 10.1002/jps.24420. Epub 2015 Mar 11.

PMID:
25762022
38.

Proceedings of the 2013 Viral Clearance Symposium (Princeton, NJ).

Roush D, Brorson K, Levy R.

PDA J Pharm Sci Technol. 2015 Jan-Feb;69(1):140-1. doi: 10.5731/pdajpst.2015.01053. No abstract available.

PMID:
25691721
39.

Post-translational structural modifications of immunoglobulin G and their effect on biological activity.

Hmiel LK, Brorson KA, Boyne MT 2nd.

Anal Bioanal Chem. 2015 Jan;407(1):79-94. doi: 10.1007/s00216-014-8108-x. Epub 2014 Sep 10. Review.

PMID:
25200070
40.

Meeting report-workshop on spike characterizations and virus removal by filtration: trends and new developments.

Willkommen H, Blümel J, Brorson K, Chen D, Chen Q, Gröner A, Hubbard BR, Kreil TR, Ruffing M, Ruiz S, Scott D, Silvester G.

PDA J Pharm Sci Technol. 2014 May-Jun;68(3):215-20. doi: 10.5731/pdajpst.2014.00981.

PMID:
25188344
41.

Meeting Report: 2013 PDA Virus & TSE Safety Forum.

Willkommen H, Blümel J, Brorson K, Chen D, Chen Q, Gröner A, Hubbard BR, Kreil TR, Ruffing M, Ruiz S, Scott D, Silvester G.

PDA J Pharm Sci Technol. 2014 May-Jun;68(3):193-214. doi: 10.5731/pdajpst.2014.00980.

PMID:
25188343
42.

Therapeutic monoclonal antibodies and consistent ends: terminal heterogeneity, detection, and impact on quality.

Brorson K, Jia AY.

Curr Opin Biotechnol. 2014 Dec;30:140-6. doi: 10.1016/j.copbio.2014.06.012. Epub 2014 Jul 12. Review.

PMID:
25022603
43.

Conference summary: gaps, lessons learned, and areas for improvement.

Brorson K, Miesegaes G, Tounekti O, Skene J, Blumel J.

PDA J Pharm Sci Technol. 2014 Jan-Feb;68(1):83-9. doi: 10.5731/pdajpst.2014.00968. No abstract available.

PMID:
24504238
44.

Role of risk assessments in viral safety: an FDA perspective.

Xu L, Lee SB, Fuchs C, Hyams KC, Brorson K, Swann P.

PDA J Pharm Sci Technol. 2014 Jan-Feb;68(1):6-10. doi: 10.5731/pdajpst.2014.00959. No abstract available.

PMID:
24504229
45.

Overview of 2009 Indianapolis conference white paper: the goal of an integrated viral clearance strategy.

Brorson K.

PDA J Pharm Sci Technol. 2014 Jan-Feb;68(1):2-5. doi: 10.5731/pdajpst.2014.00958. No abstract available.

PMID:
24504228
46.

Proceedings of the 2011 Viral Clearance Symposium (South San Francisco, CA).

Brorson K, Levy R.

PDA J Pharm Sci Technol. 2014 Jan-Feb;68(1):1. doi: 10.5731/pdajpst.2014.00957. No abstract available.

PMID:
24504227
47.

Viral clearance by flow-through mode ion exchange columns and membrane adsorbers.

Miesegaes GR, Lute SC, Read EK, Brorson KA.

Biotechnol Prog. 2014 Jan-Feb;30(1):124-31. doi: 10.1002/btpr.1832. Epub 2013 Nov 18.

PMID:
24167103
48.

Quality by design approach for viral clearance by protein a chromatography.

Zhang M, Miesegaes GR, Lee M, Coleman D, Yang B, Trexler-Schmidt M, Norling L, Lester P, Brorson KA, Chen Q.

Biotechnol Bioeng. 2014 Jan;111(1):95-103. doi: 10.1002/bit.24999. Epub 2013 Aug 16.

49.

Impact of controlled ice nucleation on process performance and quality attributes of a lyophilized monoclonal antibody.

Awotwe-Otoo D, Agarabi C, Read EK, Lute S, Brorson KA, Khan MA, Shah RB.

Int J Pharm. 2013 Jun 25;450(1-2):70-8. doi: 10.1016/j.ijpharm.2013.04.041. Epub 2013 Apr 22.

PMID:
23618961
50.

Fermentanomics informed amino acid supplementation of an antibody producing mammalian cell culture.

Read EK, Bradley SA, Smitka TA, Agarabi CD, Lute SC, Brorson KA.

Biotechnol Prog. 2013 May-Jun;29(3):745-53. doi: 10.1002/btpr.1728. Epub 2013 Apr 22.

PMID:
23606649

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