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Items: 1 to 20 of 87

1.

Comparative signature diagrams to evaluate biophysical data for differences in protein structure across various formulations.

Iyer V, Maddux N, Hu L, Cheng W, Youssef AK, Winter G, Joshi SB, Volkin DB, Middaugh CR.

J Pharm Sci. 2013 Jan;102(1):43-51. doi: 10.1002/jps.23367. Epub 2012 Nov 15.

PMID:
23160989
2.

Improved Comparative Signature Diagrams to Evaluate Similarity of Storage Stability Profiles of Different IgG1 mAbs.

Kim JH, Joshi SB, Esfandiary R, Iyer V, Bishop SM, Volkin DB, Middaugh CR.

J Pharm Sci. 2016 Mar;105(3):1028-35. doi: 10.1016/j.xphs.2016.01.008. Epub 2016 Feb 9.

PMID:
26886311
3.

Formulation design and high-throughput excipient selection based on structural integrity and conformational stability of dilute and highly concentrated IgG1 monoclonal antibody solutions.

Bhambhani A, Kissmann JM, Joshi SB, Volkin DB, Kashi RS, Middaugh CR.

J Pharm Sci. 2012 Mar;101(3):1120-35. doi: 10.1002/jps.23008. Epub 2011 Dec 6.

PMID:
22147527
4.

Biophysical characterization of Met-G-CSF: effects of different site-specific mono-pegylations on protein stability and aggregation.

Natalello A, Ami D, Collini M, D'Alfonso L, Chirico G, Tonon G, Scaramuzza S, Schrepfer R, Doglia SM.

PLoS One. 2012;7(8):e42511. doi: 10.1371/journal.pone.0042511. Epub 2012 Aug 8.

5.

Stabilization of proteins by recombinant human gelatins.

Thyagarajapuram N, Olsen D, Middaugh CR.

J Pharm Sci. 2007 Dec;96(12):3304-15.

PMID:
17542020
6.

High throughput prediction of the long-term stability of pharmaceutical macromolecules from short-term multi-instrument spectroscopic data.

Maddux NR, Iyer V, Cheng W, Youssef AM, Joshi SB, Volkin DB, Ralston JP, Winter G, Middaugh CR.

J Pharm Sci. 2014 Mar;103(3):828-39. doi: 10.1002/jps.23849. Epub 2014 Jan 13.

PMID:
24421157
7.

Methanol-induced tertiary and secondary structure changes of granulocyte-colony stimulating factor.

Yamazaki K, Iwura T, Ishikawa R, Ozaki Y.

J Biochem. 2006 Jul;140(1):49-56.

PMID:
16877768
8.

The effect of fiber truncations on the stability of adenovirus type 5.

Kupgan G, Hentges DC, Muschinske NJ, Picking WD, Picking WL, Ramsey JD.

Mol Biotechnol. 2014 Nov;56(11):979-91. doi: 10.1007/s12033-014-9777-6.

PMID:
24981329
9.

High-throughput biophysical analysis and data visualization of conformational stability of an IgG1 monoclonal antibody after deglycosylation.

Alsenaidy MA, Kim JH, Majumdar R, Weis DD, Joshi SB, Tolbert TJ, Middaugh CR, Volkin DB.

J Pharm Sci. 2013 Nov;102(11):3942-56. doi: 10.1002/jps.23730. Epub 2013 Sep 24.

10.

Assessing analytical comparability of biosimilars: GCSF as a case study.

Nupur N, Singh SK, Narula G, Rathore AS.

J Chromatogr B Analyt Technol Biomed Life Sci. 2016 Oct 1;1032:165-71. doi: 10.1016/j.jchromb.2016.05.027. Epub 2016 May 21.

PMID:
27289250
11.

Highly concentrated monoclonal antibody solutions: direct analysis of physical structure and thermal stability.

Harn N, Allan C, Oliver C, Middaugh CR.

J Pharm Sci. 2007 Mar;96(3):532-46.

PMID:
17083094
12.

Protein comparability assessments and potential applicability of high throughput biophysical methods and data visualization tools to compare physical stability profiles.

Alsenaidy MA, Jain NK, Kim JH, Middaugh CR, Volkin DB.

Front Pharmacol. 2014 Mar 12;5:39. doi: 10.3389/fphar.2014.00039. eCollection 2014. Review.

13.

Comparison between biosimilar filgrastim vs other granulocyte-colony stimulating factor formulations (originator filgrastim, peg-filgrastim and lenograstim) after autologous stem cell transplantation: a retrospective survey from the Rome Transplant Network.

Marchesi F, Cerchiara E, Dessanti ML, Gumenyuk S, Franceschini L, Palombi F, Pisani F, Romano A, Spadea A, Pupo L, Annibali O, La Malfa A, Arcese W, Mengarelli A.

Br J Haematol. 2015 Apr;169(2):293-6. doi: 10.1111/bjh.13199. Epub 2014 Nov 5. No abstract available.

PMID:
25371286
14.

Structure and activity of granulocyte colony-stimulating factor derived from CHO cells containing cDNA coding for alternatively spliced sequences.

Arakawa T, Horan TP, Leong K, Prestrelski SJ, Narhi LO, Hu S.

Arch Biochem Biophys. 1995 Jan 10;316(1):285-9.

PMID:
7530936
15.

Conformational analysis of protein secondary structure during spray-drying of antibody/mannitol formulations.

Schüle S, Friess W, Bechtold-Peters K, Garidel P.

Eur J Pharm Biopharm. 2007 Jan;65(1):1-9. Epub 2006 Sep 1.

PMID:
17034996
16.

Establishing analytical comparability for "biosimilars": filgrastim as a case study.

Rathore AS, Bhambure R.

Anal Bioanal Chem. 2014 Oct;406(26):6569-76. doi: 10.1007/s00216-014-7887-4. Epub 2014 May 28.

PMID:
24866713
17.

Formulation development of therapeutic monoclonal antibodies using high-throughput fluorescence and static light scattering techniques: role of conformational and colloidal stability.

Goldberg DS, Bishop SM, Shah AU, Sathish HA.

J Pharm Sci. 2011 Apr;100(4):1306-15. doi: 10.1002/jps.22371. Epub 2010 Oct 19.

PMID:
20960568
18.

Circular permutation of granulocyte colony-stimulating factor.

Feng Y, Minnerly JC, Zurfluh LL, Joy WD, Hood WF, Abegg AL, Grabbe ES, Shieh JJ, Thurman TL, McKearn JP, McWherter CA.

Biochemistry. 1999 Apr 6;38(14):4553-63.

PMID:
10194377
19.

Examination of thermal unfolding and aggregation profiles of a series of developable therapeutic monoclonal antibodies.

Brader ML, Estey T, Bai S, Alston RW, Lucas KK, Lantz S, Landsman P, Maloney KM.

Mol Pharm. 2015 Apr 6;12(4):1005-17. doi: 10.1021/mp400666b. Epub 2015 Feb 27.

PMID:
25687223
20.

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