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Items: 42

1.

2018 White Paper on Recent Issues in Bioanalysis: focus on immunogenicity assays by hybrid LBA/LCMS and regulatory feedback (Part 2 - PK, PD & ADA assays by hybrid LBA/LCMS & regulatory agencies' inputs on bioanalysis, biomarkers and immunogenicity).

Neubert H, Olah T, Lee A, Fraser S, Dodge R, Laterza O, Szapacs M, Alley SC, Saad OM, Amur S, Chen L, Cherry E, Cho SJ, Cludts I, Donato LD, Edmison A, Ferrari L, Garofolo F, Haidar S, Hopper S, Hottenstein S, Ishii-Watabe A, Kassim S, Kurki P, Lima Santos GM, Miscoria G, Palandra J, Pedras-Vasconcelos J, Piccoli S, Rogstad S, Saito Y, Savoie N, Sikorski T, Spitz S, Staelens L, Verthelyi D, Vinter S, Wadhwa M, Wang YM, Welink J, Weng N, Whale E, Woolf E, Wu J, Yan H, Yu H, Zhou S.

Bioanalysis. 2018 Nov 29. doi: 10.4155/bio-2018-0285. [Epub ahead of print]

2.

Engineered cysteine antibodies: an improved antibody-drug conjugate platform with a novel mechanism of drug-linker stability.

Sussman D, Westendorf L, Meyer DW, Leiske CI, Anderson M, Okeley NM, Alley SC, Lyon R, Sanderson RJ, Carter PJ, Benjamin DR.

Protein Eng Des Sel. 2018 Feb 1;31(2):47-54. doi: 10.1093/protein/gzx067.

PMID:
29370435
3.

2017 White Paper on recent issues in bioanalysis: aren't BMV guidance/guidelines 'Scientific'? (Part 1 - LCMS: small molecules, peptides and small molecule biomarkers).

Welink J, Yang E, Hughes N, Rago B, Woolf E, Sydor J, Coppola L, Ackermann B, Li W, Alley SC, Arnold M, Berger I, Briscoe C, Buonarati M, Bustard M, Cancilla M, Cho SJ, Duggan J, Fraier D, Garofolo F, Green R, Haidar S, Hittle L, Ishii-Watabe A, Islam R, Jenkins R, Jones B, Kadavil J, Kassim S, Kavetska O, Blaye OL, Lee A, Liu H, Mehl J, Lima Santos GM, Musuku A, Ramanathan R, Saito Y, Savoie N, Summerfield S, Surapaneni S, Szapacs M, Tampal N, Verhaeghe T, Vinter S, Whale E.

Bioanalysis. 2017 Nov;9(22):1807-1825. doi: 10.4155/bio-2017-4975. Epub 2017 Nov 17.

4.

Antibody-conjugated drug assay for protease-cleavable antibody-drug conjugates.

Sanderson RJ, Nicholas ND, Baker Lee C, Hengel SM, Lyon RP, Benjamin DR, Alley SC.

Bioanalysis. 2016;8(1):55-63. doi: 10.4155/bio.15.230. Epub 2015 Dec 9.

PMID:
26647801
5.

2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 2 - hybrid LBA/LCMS and input from regulatory agencies).

Ackermann B, Neubert H, Hughes N, Garofolo F, Abberley L, Alley SC, Brown-Augsburger P, Bustard M, Chen LZ, Heinrich J, Katori N, Kaur S, Kirkovsky L, Laterza OF, Le Blaye O, Lévesque A, Santos GM, Olah T, Savoie N, Skelly M, Spitz S, Szapacs M, Tampal N, Wang J, Welink J, Wieling J, Haidar S, Vinter S, Whale E, Witte B.

Bioanalysis. 2015 Dec;7(23):3019-34. doi: 10.4155/bio.15.214. Epub 2015 Dec 2.

6.

2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 3 - LBA and immunogenicity).

Stevenson L, Amaravadi L, Myler H, Salazar-Fontana L, Gorovits B, Kirshner S, Xue L, Garofolo F, Alley SC, Thway T, Joyce A, Bansal S, Beaver C, Bergeron A, Cai XY, Cojocaru L, DeSilva B, Dumont I, Fluhler E, Fraser S, Gouty D, Gupta S, Haidar S, Hayes R, Ingelse B, Ishii-Watabe A, Kaur S, King L, Laterza O, Leung S, Lévesque A, Ma M, Petit-Frere C, Pillutla R, Rose M, Schultz G, Smeraglia J, Swanson S, Torri A, Vazvaei F, Wakelin-Smith J, Wilson A, Woolf E, Yang TY.

Bioanalysis. 2014;6(24):3355-68. doi: 10.4155/bio.14.283.

7.

2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 2 - hybrid LBA/LCMS, ELN & regulatory agencies' input).

Dufield D, Neubert H, Garofolo F, Kirkovsky L, Stevenson L, Dumont I, Kaur S, Xu K, Alley SC, Szapacs M, Arnold M, Bansal S, Haidar S, Welink J, Le Blaye O, Wakelin-Smith J, Whale E, Ishii-Watabe A, Bustard M, Katori N, Amaravadi L, Aubry AF, Beaver C, Bergeron A, Cai XY, Cojocaru L, DeSilva B, Duggan J, Fluhler E, Gorovits B, Gupta S, Hayes R, Ho S, Ingelse B, King L, Lévesque A, Lowes S, Ma M, Musuku A, Myler H, Olah T, Patel S, Rose M, Schultz G, Smeraglia J, Swanson S, Torri A, Vazvaei F, Wilson A, Woolf E, Xue L, Yang TY.

Bioanalysis. 2014;6(23):3237-49. doi: 10.4155/bio.14.279.

8.

Measurement of in vivo drug load distribution of cysteine-linked antibody-drug conjugates using microscale liquid chromatography mass spectrometry.

Hengel SM, Sanderson R, Valliere-Douglass J, Nicholas N, Leiske C, Alley SC.

Anal Chem. 2014 Apr 1;86(7):3420-5. doi: 10.1021/ac403860c. Epub 2014 Mar 14.

PMID:
24576206
9.

Advancing antibody drug conjugation: from the laboratory to a clinically approved anticancer drug.

Okeley NM, Alley SC, Senter PD.

Hematol Oncol Clin North Am. 2014 Feb;28(1):13-25. doi: 10.1016/j.hoc.2013.10.009. Review.

PMID:
24287064
10.

Metabolic engineering of monoclonal antibody carbohydrates for antibody-drug conjugation.

Okeley NM, Toki BE, Zhang X, Jeffrey SC, Burke PJ, Alley SC, Senter PD.

Bioconjug Chem. 2013 Oct 16;24(10):1650-5. doi: 10.1021/bc4002695. Epub 2013 Sep 19.

PMID:
24050213
11.

CYP3A-mediated drug-drug interaction potential and excretion of brentuximab vedotin, an antibody-drug conjugate, in patients with CD30-positive hematologic malignancies.

Han TH, Gopal AK, Ramchandren R, Goy A, Chen R, Matous JV, Cooper M, Grove LE, Alley SC, Lynch CM, O'Connor OA.

J Clin Pharmacol. 2013 Aug;53(8):866-77. doi: 10.1002/jcph.116. Epub 2013 Jun 10.

12.

Bioanalysis of antibody-drug conjugates: American Association of Pharmaceutical Scientists Antibody-Drug Conjugate Working Group position paper.

Gorovits B, Alley SC, Bilic S, Booth B, Kaur S, Oldfield P, Purushothama S, Rao C, Shord S, Siguenza P.

Bioanalysis. 2013 May;5(9):997-1006. doi: 10.4155/bio.13.38.

13.

Analytical and bioanalytical technologies for characterizing antibody-drug conjugates.

Alley SC, Anderson KE.

Curr Opin Chem Biol. 2013 Jun;17(3):406-11. doi: 10.1016/j.cbpa.2013.03.022. Epub 2013 Apr 6. Review.

PMID:
23570980
14.

Development of orally active inhibitors of protein and cellular fucosylation.

Okeley NM, Alley SC, Anderson ME, Boursalian TE, Burke PJ, Emmerton KM, Jeffrey SC, Klussman K, Law CL, Sussman D, Toki BE, Westendorf L, Zeng W, Zhang X, Benjamin DR, Senter PD.

Proc Natl Acad Sci U S A. 2013 Apr 2;110(14):5404-9. doi: 10.1073/pnas.1222263110. Epub 2013 Mar 14.

15.

Antibody-drug conjugates: targeted drug delivery for cancer.

Alley SC, Okeley NM, Senter PD.

Curr Opin Chem Biol. 2010 Aug;14(4):529-37. doi: 10.1016/j.cbpa.2010.06.170. Epub 2010 Jul 17. Review.

PMID:
20643572
16.

Intracellular activation of SGN-35, a potent anti-CD30 antibody-drug conjugate.

Okeley NM, Miyamoto JB, Zhang X, Sanderson RJ, Benjamin DR, Sievers EL, Senter PD, Alley SC.

Clin Cancer Res. 2010 Feb 1;16(3):888-97. doi: 10.1158/1078-0432.CCR-09-2069. Epub 2010 Jan 19. Erratum in: Clin Cancer Res. 2011 Aug 15;17(16):5524.

17.

The pharmacologic basis for antibody-auristatin conjugate activity.

Alley SC, Zhang X, Okeley NM, Anderson M, Law CL, Senter PD, Benjamin DR.

J Pharmacol Exp Ther. 2009 Sep;330(3):932-8. doi: 10.1124/jpet.109.155549. Epub 2009 Jun 4.

PMID:
19498104
18.

Potent antitumor activity of the anti-CD19 auristatin antibody drug conjugate hBU12-vcMMAE against rituximab-sensitive and -resistant lymphomas.

Gerber HP, Kung-Sutherland M, Stone I, Morris-Tilden C, Miyamoto J, McCormick R, Alley SC, Okeley N, Hayes B, Hernandez-Ilizaliturri FJ, McDonagh CF, Carter PJ, Benjamin D, Grewal IS.

Blood. 2009 Apr 30;113(18):4352-61. doi: 10.1182/blood-2008-09-179143. Epub 2009 Jan 15.

PMID:
19147785
19.

Engineered anti-CD70 antibody-drug conjugate with increased therapeutic index.

McDonagh CF, Kim KM, Turcott E, Brown LL, Westendorf L, Feist T, Sussman D, Stone I, Anderson M, Miyamoto J, Lyon R, Alley SC, Gerber HP, Carter PJ.

Mol Cancer Ther. 2008 Sep;7(9):2913-23. doi: 10.1158/1535-7163.MCT-08-0295.

20.

Anti-CD30 diabody-drug conjugates with potent antitumor activity.

Kim KM, McDonagh CF, Westendorf L, Brown LL, Sussman D, Feist T, Lyon R, Alley SC, Okeley NM, Zhang X, Thompson MC, Stone I, Gerber HP, Carter PJ.

Mol Cancer Ther. 2008 Aug;7(8):2486-97. doi: 10.1158/1535-7163.MCT-08-0388.

21.

Contribution of linker stability to the activities of anticancer immunoconjugates.

Alley SC, Benjamin DR, Jeffrey SC, Okeley NM, Meyer DL, Sanderson RJ, Senter PD.

Bioconjug Chem. 2008 Mar;19(3):759-65. doi: 10.1021/bc7004329. Epub 2008 Mar 4.

PMID:
18314937
22.

Potent cytotoxicity of an auristatin-containing antibody-drug conjugate targeting melanoma cells expressing melanotransferrin/p97.

Smith LM, Nesterova A, Alley SC, Torgov MY, Carter PJ.

Mol Cancer Ther. 2006 Jun;5(6):1474-82.

23.

Engineered antibody-drug conjugates with defined sites and stoichiometries of drug attachment.

McDonagh CF, Turcott E, Westendorf L, Webster JB, Alley SC, Kim K, Andreyka J, Stone I, Hamblett KJ, Francisco JA, Carter P.

Protein Eng Des Sel. 2006 Jul;19(7):299-307. Epub 2006 Apr 27.

PMID:
16644914
24.

Enhanced activity of monomethylauristatin F through monoclonal antibody delivery: effects of linker technology on efficacy and toxicity.

Doronina SO, Mendelsohn BA, Bovee TD, Cerveny CG, Alley SC, Meyer DL, Oflazoglu E, Toki BE, Sanderson RJ, Zabinski RF, Wahl AF, Senter PD.

Bioconjug Chem. 2006 Jan-Feb;17(1):114-24.

PMID:
16417259
25.

Reduction-alkylation strategies for the modification of specific monoclonal antibody disulfides.

Sun MM, Beam KS, Cerveny CG, Hamblett KJ, Blackmore RS, Torgov MY, Handley FG, Ihle NC, Senter PD, Alley SC.

Bioconjug Chem. 2005 Sep-Oct;16(5):1282-90.

26.

Identification and mapping of protein-protein interactions by a combination of cross-linking, cleavage, and proteomics.

Trakselis MA, Alley SC, Ishmael FT.

Bioconjug Chem. 2005 Jul-Aug;16(4):741-50. Review.

PMID:
16029014
27.

Generation of an intensely potent anthracycline by a monoclonal antibody-beta-galactosidase conjugate.

Torgov MY, Alley SC, Cerveny CG, Farquhar D, Senter PD.

Bioconjug Chem. 2005 May-Jun;16(3):717-21.

PMID:
15898742
28.

Sequence-dependent dynamics of duplex DNA: the applicability of a dinucleotide model.

Okonogi TM, Alley SC, Reese AW, Hopkins PB, Robinson BH.

Biophys J. 2002 Dec;83(6):3446-59.

29.

Phosphate backbone neutralization increases duplex DNA flexibility: a model for protein binding.

Okonogi TM, Alley SC, Harwood EA, Hopkins PB, Robinson BH.

Proc Natl Acad Sci U S A. 2002 Apr 2;99(7):4156-60.

30.

Assembly of the bacteriophage T4 helicase: architecture and stoichiometry of the gp41-gp59 complex.

Ishmael FT, Alley SC, Benkovic SJ.

J Biol Chem. 2002 Jun 7;277(23):20555-62. Epub 2002 Apr 1.

31.

Building a replisome solution structure by elucidation of protein-protein interactions in the bacteriophage T4 DNA polymerase holoenzyme.

Alley SC, Trakselis MA, Mayer MU, Ishmael FT, Jones AD, Benkovic SJ.

J Biol Chem. 2001 Oct 19;276(42):39340-9. Epub 2001 Aug 14.

32.

Creating a dynamic picture of the sliding clamp during T4 DNA polymerase holoenzyme assembly by using fluorescence resonance energy transfer.

Trakselis MA, Alley SC, Abel-Santos E, Benkovic SJ.

Proc Natl Acad Sci U S A. 2001 Jul 17;98(15):8368-75.

33.

Recruitment of HAT complexes by direct activator interactions with the ATM-related Tra1 subunit.

Brown CE, Howe L, Sousa K, Alley SC, Carrozza MJ, Tan S, Workman JL.

Science. 2001 Jun 22;292(5525):2333-7.

34.

Identification and mapping of protein-protein interactions between gp32 and gp59 by cross-linking.

Ishmael FT, Alley SC, Benkovic SJ.

J Biol Chem. 2001 Jul 6;276(27):25236-42. Epub 2001 Apr 17.

35.

Sequence-dependent dynamics in duplex DNA.

Okonogi TM, Alley SC, Reese AW, Hopkins PB, Robinson BH.

Biophys J. 2000 May;78(5):2560-71.

36.

Tracking sliding clamp opening and closing during bacteriophage T4 DNA polymerase holoenzyme assembly.

Alley SC, Abel-Santos E, Benkovic SJ.

Biochemistry. 2000 Mar 21;39(11):3076-90.

PMID:
10715129
37.

Flexibility of duplex DNA on the submicrosecond timescale.

Okonogi TM, Reese AW, Alley SC, Hopkins PB, Robinson BH.

Biophys J. 1999 Dec;77(6):3256-76.

38.

The carboxyl terminus of the bacteriophage T4 DNA polymerase contacts its sliding clamp at the subunit interface.

Alley SC, Jones AD, Soumillion P, Benkovic SJ.

J Biol Chem. 1999 Aug 27;274(35):24485-9.

39.

Sliding clamp of the bacteriophage T4 polymerase has open and closed subunit interfaces in solution.

Alley SC, Shier VK, Abel-Santos E, Sexton DJ, Soumillion P, Benkovic SJ.

Biochemistry. 1999 Jun 15;38(24):7696-709.

PMID:
10387009
40.

Bending of DNA by the mitomycin C-induced, GpG intrastrand cross-link.

Rink SM, Lipman R, Alley SC, Hopkins PB, Tomasz M.

Chem Res Toxicol. 1996 Mar;9(2):382-9.

PMID:
8839039
41.

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