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Items: 1 to 20 of 95

1.

Host cell protein quantification of an optimized purification method by mass spectrometry.

Reiter K, Suzuki M, Olano LR, Narum DL.

J Pharm Biomed Anal. 2019 Sep 10;174:650-654. doi: 10.1016/j.jpba.2019.06.038. Epub 2019 Jun 28.

PMID:
31279895
2.

Assessment of the impact of manufacturing changes on the physicochemical properties of the recombinant vaccine carrier ExoProtein A.

Burkhardt M, Reiter K, Nguyen V, Suzuki M, Herrera R, Duffy PE, Shimp R Jr, MacDonald NJ, Olano LR, Narum DL.

Vaccine. 2019 Sep 10;37(38):5762-5769. doi: 10.1016/j.vaccine.2018.09.037. Epub 2018 Sep 24.

PMID:
30262247
3.

A modular and adaptive mass spectrometry-based platform for support of bioprocess development toward optimal host cell protein clearance.

Walker DE, Yang F, Carver J, Joe K, Michels DA, Yu XC.

MAbs. 2017 May/Jun;9(4):654-663. doi: 10.1080/19420862.2017.1303023. Epub 2017 Mar 27.

4.

Comparison of platform host cell protein ELISA to process-specific host cell protein ELISA.

Gunawan F, Nishihara J, Liu P, Sandoval W, Vanderlaan M, Zhang H, Krawitz D.

Biotechnol Bioeng. 2018 Feb;115(2):382-389. doi: 10.1002/bit.26466. Epub 2017 Oct 30.

PMID:
28986978
5.

Host cell protein testing strategy for hepatitis B antigen in Hexavalent vaccine - Towards a general testing strategy for recombinant vaccines.

Toinon A, Fontaine C, Thion L, Gajewska B, Carpick B, Nougarede N, Uhlrich S.

Biologicals. 2018 Jul;54:1-7. doi: 10.1016/j.biologicals.2018.05.006. Epub 2018 May 31.

PMID:
29861269
6.

Identification of a host cell protein impurity in therapeutic protein, P1.

Ahluwalia D, Dhillon H, Slaney T, Song H, Boux H, Mehta S, Zhang L, Valdez A, Krishnamurthy G.

J Pharm Biomed Anal. 2017 Jul 15;141:32-38. doi: 10.1016/j.jpba.2017.03.065. Epub 2017 Apr 9.

PMID:
28419935
7.

Analysis of host-cell proteins in biotherapeutic proteins by comprehensive online two-dimensional liquid chromatography/mass spectrometry.

Doneanu CE, Xenopoulos A, Fadgen K, Murphy J, Skilton SJ, Prentice H, Stapels M, Chen W.

MAbs. 2012 Jan-Feb;4(1):24-44. doi: 10.4161/mabs.4.1.18748.

8.

Enhanced Detection of Low-Abundance Host Cell Protein Impurities in High-Purity Monoclonal Antibodies Down to 1 ppm Using Ion Mobility Mass Spectrometry Coupled with Multidimensional Liquid Chromatography.

Doneanu CE, Anderson M, Williams BJ, Lauber MA, Chakraborty A, Chen W.

Anal Chem. 2015 Oct 20;87(20):10283-91. doi: 10.1021/acs.analchem.5b02103. Epub 2015 Sep 10.

PMID:
26266576
9.

Improved detection of host cell proteins (HCPs) in a mammalian cell-derived antibody drug using liquid chromatography/mass spectrometry in conjunction with an HCP-enrichment strategy.

Thompson JH, Chung WK, Zhu M, Tie L, Lu Y, Aboulaich N, Strouse R, Mo WD.

Rapid Commun Mass Spectrom. 2014 Apr 30;28(8):855-60. doi: 10.1002/rcm.6854.

PMID:
24623688
10.

More similar than different: Host cell protein production using three null CHO cell lines.

Yuk IH, Nishihara J, Walker D Jr, Huang E, Gunawan F, Subramanian J, Pynn AF, Yu XC, Zhu-Shimoni J, Vanderlaan M, Krawitz DC.

Biotechnol Bioeng. 2015 Oct;112(10):2068-83. doi: 10.1002/bit.25615. Epub 2015 May 12.

PMID:
25894672
11.

Quantitative host cell protein analysis using two dimensional data independent LC-MS(E).

Farrell A, Mittermayr S, Morrissey B, Mc Loughlin N, Navas Iglesias N, Marison IW, Bones J.

Anal Chem. 2015 Sep 15;87(18):9186-93. doi: 10.1021/acs.analchem.5b01377. Epub 2015 Aug 27.

PMID:
26280711
12.

Mass spectrometric evaluation of upstream and downstream process influences on host cell protein patterns in biopharmaceutical products.

Falkenberg H, Waldera-Lupa DM, Vanderlaan M, Schwab T, Krapfenbauer K, Studts JM, Flad T, Waerner T.

Biotechnol Prog. 2019 May;35(3):e2788. doi: 10.1002/btpr.2788. Epub 2019 Mar 6.

PMID:
30767403
13.

Identification and characterization of co-purifying CHO host cell proteins in monoclonal antibody purification process.

Liu X, Chen Y, Zhao Y, Liu-Compton V, Chen W, Payne G, Lazar AC.

J Pharm Biomed Anal. 2019 Sep 10;174:500-508. doi: 10.1016/j.jpba.2019.06.021. Epub 2019 Jun 18.

PMID:
31234041
14.

ELISA reagent coverage evaluation by affinity purification tandem mass spectrometry.

Henry SM, Sutlief E, Salas-Solano O, Valliere-Douglass J.

MAbs. 2017 Oct;9(7):1065-1075. doi: 10.1080/19420862.2017.1349586. Epub 2017 Jul 14.

15.

A Novel Sample Preparation for Shotgun Proteomics Characterization of HCPs in Antibodies.

Huang L, Wang N, Mitchell CE, Brownlee T, Maple SR, De Felippis MR.

Anal Chem. 2017 May 16;89(10):5436-5444. doi: 10.1021/acs.analchem.7b00304. Epub 2017 Apr 26.

PMID:
28414239
16.

Identification and quantification of host cell protein impurities in biotherapeutics using mass spectrometry.

Schenauer MR, Flynn GC, Goetze AM.

Anal Biochem. 2012 Sep 15;428(2):150-7. doi: 10.1016/j.ab.2012.05.018. Epub 2012 May 26.

PMID:
22640604
17.

Evaluating Immunogenicity Risk Due to Host Cell Protein Impurities in Antibody-Based Biotherapeutics.

Jawa V, Joubert MK, Zhang Q, Deshpande M, Hapuarachchi S, Hall MP, Flynn GC.

AAPS J. 2016 Nov;18(6):1439-1452. Epub 2016 Jul 22.

PMID:
27450229
18.

Toward the complete characterization of host cell proteins in biotherapeutics via affinity depletions, LC-MS/MS, and multivariate analysis.

Madsen JA, Farutin V, Carbeau T, Wudyka S, Yin Y, Smith S, Anderson J, Capila I.

MAbs. 2015;7(6):1128-37. doi: 10.1080/19420862.2015.1082017. Epub 2015 Aug 20.

19.

Trace levels of the CHO host cell protease cathepsin D caused particle formation in a monoclonal antibody product.

Bee JS, Tie L, Johnson D, Dimitrova MN, Jusino KC, Afdahl CD.

Biotechnol Prog. 2015 Sep-Oct;31(5):1360-9. doi: 10.1002/btpr.2150. Epub 2015 Aug 25.

PMID:
26259961
20.

Host cell protein testing by ELISAs and the use of orthogonal methods.

Zhu-Shimoni J, Yu C, Nishihara J, Wong RM, Gunawan F, Lin M, Krawitz D, Liu P, Sandoval W, Vanderlaan M.

Biotechnol Bioeng. 2014 Dec;111(12):2367-79. doi: 10.1002/bit.25327. Epub 2014 Sep 10. Review.

PMID:
24995961

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