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Items: 49

1.

Development of small-scale models to understand the impact of continuous downstream bioprocessing on integrated virus filtration.

Lute S, Kozaili J, Johnson S, Kobayashi K, Strauss D.

Biotechnol Prog. 2020 Jan 16:e2962. doi: 10.1002/btpr.2962. [Epub ahead of print]

PMID:
31945257
2.

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
3.

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
4.

Twin Screw Granulation: Effects of Properties of Primary Powders.

Lute SV, Dhenge RM, Salman AD.

Pharmaceutics. 2018 Jun 2;10(2). pii: E68. doi: 10.3390/pharmaceutics10020068.

5.

Twin Screw Granulation: An Investigation of the Effect of Barrel Fill Level.

Lute SV, Dhenge RM, Salman AD.

Pharmaceutics. 2018 Jun 1;10(2). pii: E67. doi: 10.3390/pharmaceutics10020067.

6.

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
7.

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
8.

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
9.

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
10.

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
11.

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
12.

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
13.

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
14.

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
15.

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
16.

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.

17.

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
18.

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
19.

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.

20.

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
21.

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
22.

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
23.

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
24.

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
25.

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
26.

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
27.

Evidence for grow-through penetration of 0.2-μm-pore-size filters by Serratia marcescens and Brevundimonas diminuta.

Kaushal S, Gervais B, Lute S, Eroraha A, Faustino P, Brorson K, Hussong D.

J Ind Microbiol Biotechnol. 2013 Apr;40(3-4):327-34. doi: 10.1007/s10295-013-1232-3. Epub 2013 Feb 6.

PMID:
23385852
28.

A survey of quality attributes of virus spike preparations used in clearance studies.

Miesegaes G, Lute S, Dement-Brown J, Kaushal S, Strauss D, Chen D, Brorson K.

PDA J Pharm Sci Technol. 2012 Sep-Oct;66(5):420-33. doi: 10.5731/pdajpst.2012.00879.

PMID:
23035026
29.

Quality by design: impact of formulation variables and their interactions on quality attributes of a lyophilized monoclonal antibody.

Awotwe-Otoo D, Agarabi C, Wu GK, Casey E, Read E, Lute S, Brorson KA, Khan MA, Shah RB.

Int J Pharm. 2012 Nov 15;438(1-2):167-75. doi: 10.1016/j.ijpharm.2012.08.033. Epub 2012 Aug 25.

PMID:
22944306
30.

Chemometrics applications in biotechnology processes: predicting column integrity and impurity clearance during reuse of chromatography resin.

Rathore AS, Mittal S, Lute S, Brorson K.

Biotechnol Prog. 2012 Sep-Oct;28(5):1308-14. doi: 10.1002/btpr.1610. Epub 2012 Sep 18.

PMID:
22888107
31.

Monoclonal antibody capture and viral clearance by cation exchange chromatography.

Miesegaes GR, Lute S, Strauss DM, Read EK, Venkiteshwaran A, Kreuzman A, Shah R, Shamlou P, Chen D, Brorson K.

Biotechnol Bioeng. 2012 Aug;109(8):2048-58. doi: 10.1002/bit.24480. Epub 2012 Apr 8.

PMID:
22488719
32.

Analysis of viral clearance unit operations for monoclonal antibodies.

Miesegaes G, Lute S, Brorson K.

Biotechnol Bioeng. 2010 Jun 1;106(2):238-46. doi: 10.1002/bit.22662.

PMID:
20073086
33.

Use of Hydrogenophaga pseudoflava penetration to quantitatively assess the impact of filtration parameters for 0.2-micrometer-pore-size filters.

Lee A, McVey J, Faustino P, Lute S, Sweeney N, Pawar V, Khan M, Brorson K, Hussong D.

Appl Environ Microbiol. 2010 Feb;76(3):695-700. doi: 10.1128/AEM.01825-09. Epub 2009 Dec 4.

34.

Multiplex RT Q-PCR assay for simultaneous quantification of three viruses used for validation of virus clearance by biopharmaceutical production.

Lute S, Wang H, Sanchez D, Barletta J, Chen Q, Brorson K.

Biologicals. 2009 Oct;37(5):331-7. doi: 10.1016/j.biologicals.2009.07.002. Epub 2009 Aug 15.

PMID:
19683941
35.

Understanding the mechanism of virus removal by Q sepharose fast flow chromatography during the purification of CHO-cell derived biotherapeutics.

Strauss DM, Lute S, Tebaykina Z, Frey DD, Ho C, Blank GS, Brorson K, Chen Q, Yang B.

Biotechnol Bioeng. 2009 Oct 1;104(2):371-80. doi: 10.1002/bit.22416.

PMID:
19575414
36.

Particle concentration measurement of virus samples using electrospray differential mobility analysis and quantitative amino acid analysis.

Cole KD, Pease LF 3rd, Tsai DH, Singh T, Lute S, Brorson KA, Wang L.

J Chromatogr A. 2009 Jul 24;1216(30):5715-22. doi: 10.1016/j.chroma.2009.05.083. Epub 2009 Jun 6.

PMID:
19545873
37.

Removal of endogenous retrovirus-like particles from CHO-cell derived products using Q sepharose fast flow chromatography.

Strauss DM, Lute S, Brorson K, Blank GS, Chen Q, Yang B.

Biotechnol Prog. 2009 Jul-Aug;25(4):1194-7. doi: 10.1002/btpr.249.

PMID:
19452543
38.

Bacteriophage and impurity carryover and total organic carbon release during extended protein A chromatography.

Lute S, Brorson K.

J Chromatogr A. 2009 May 1;1216(18):3774-83. doi: 10.1016/j.chroma.2009.02.050. Epub 2009 Feb 21.

PMID:
19285678
39.

A consensus rating method for small virus-retentive filters. II. Method evaluation.

Brorson K, Lute S, Haque M, Martin J, Sato T, Moroe I, Morgan M, Krishnan M, Campbell J, Genest P, Parrella J, Dolan S, Martin S, Tarrach K, Levy R; PDA Virus Filter Task Force, Aranha H, Bailey M, Bender J, Carter J, Chen Q, Dowd C, Jani R, Jen D, Kidd S, Meltzer T, Remington K, Rice I, Romero C, Sato T, Jornitz M, Sekura CM, Sofer G, Specht R, Wojciechowski P.

PDA J Pharm Sci Technol. 2008 Sep-Oct;62(5):334-43.

PMID:
19055229
40.

A consensus rating method for small virus-retentive filters. I. Method development.

Lute S, Riordan W, Pease LF 3rd, Tsai DH, Levy R, Haque M, Martin J, Moroe I, Sato T, Morgan M, Krishnan M, Campbell J, Genest P, Dolan S, Tarrach K, Meyer A; PDA Virus Filter TAsk Force, Zachariah MR, Tarlov MJ, EtzeL M, Brorson K, Aranha H, Bailey M, Bender J, Carter J, Chen Q, Dowd C, Jani R, Jen D, Kidd S, Meltzer T, Remington K, Rice I, Romero C, Sato T, Jornitz M, Sekura CM, Sofer G, Specht R, Wojciechowski P; Parenteral Drug Association Virus Filter Task Force.

PDA J Pharm Sci Technol. 2008 Sep-Oct;62(5):318-33.

PMID:
19055228
41.

A novel, Q-PCR based approach to measuring endogenous retroviral clearance by capture protein A chromatography.

Zhang M, Lute S, Norling L, Hong C, Safta A, O'Connor D, Bernstein LJ, Wang H, Blank G, Brorson K, Chen Q.

Biotechnol Bioeng. 2009 Apr 1;102(5):1438-47. doi: 10.1002/bit.22172.

PMID:
18988264
42.

Characterization and purification of bacteriophages using chromatofocusing.

Brorson K, Shen H, Lute S, Pérez JS, Frey DD.

J Chromatogr A. 2008 Oct 17;1207(1-2):110-21. doi: 10.1016/j.chroma.2008.08.037. Epub 2008 Aug 15.

PMID:
18778829
43.

Robustness of virus removal by protein A chromatography is independent of media lifetime.

Lute S, Norling L, Hanson M, Emery R, Stinson D, Padua K, Blank G, Chen Q, Brorson K.

J Chromatogr A. 2008 Sep 26;1205(1-2):17-25. doi: 10.1016/j.chroma.2008.07.094. Epub 2008 Aug 9.

PMID:
18722622
44.

Phage passage after extended processing in small-virus-retentive filters.

Lute S, Bailey M, Combs J, Sukumar M, Brorson K.

Biotechnol Appl Biochem. 2007 Jul;47(Pt 3):141-51. Erratum in: Biotechnol Appl Biochem. 2007 Sep;48(Pt 1):63.

PMID:
17286554
45.

"Large pore size" virus filter test method recommended by the PDA Virus Filter Task Force.

Brorson K, Sofer G, Robertson G, Lute S, Martin J, Aranha H, Haque M, Satoh S, Yoshinari K, Moroe I, Morgan M, Yamaguchi F, Carter J, Krishnan M, Stefanyk J, Etzel M, Riorden W, Korneyeva M, Sundaram S, Wilkommen H, Wojciechowski P.

PDA J Pharm Sci Technol. 2005 May-Jun;59(3):177-86. No abstract available.

PMID:
16048117
46.

Normal-flow virus filtration: detection and assessment of the endpoint in bio-processing.

Bolton G, Cabatingan M, Rubino M, Lute S, Brorson K, Bailey M.

Biotechnol Appl Biochem. 2005 Oct;42(Pt 2):133-42.

PMID:
15901236
47.

Impact of multiple re-use of anion-exchange chromatography media on virus removal.

Norling L, Lute S, Emery R, Khuu W, Voisard M, Xu Y, Chen Q, Blank G, Brorson K.

J Chromatogr A. 2005 Mar 25;1069(1):79-89.

PMID:
15844485
48.

Current and future approaches to ensure the viral safety of biopharmaceuticals.

Brorson K, Norling L, Hamilton E, Lute S, Lee K, Curtis S, Xu Y.

Dev Biol (Basel). 2004;118:17-29. No abstract available.

PMID:
15645669
49.

Characterization of coliphage PR772 and evaluation of its use for virus filter performance testing.

Lute S, Aranha H, Tremblay D, Liang D, Ackermann HW, Chu B, Moineau S, Brorson K.

Appl Environ Microbiol. 2004 Aug;70(8):4864-71.

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