214 related articles for article (PubMed ID: 29958062)
1. Heterologous recombinant expression of non-originator NISTmAb.
Kashi L; Yandrofski K; Preston RJ; Arbogast LW; Giddens JP; Marino JP; Schiel JE; Kelman Z
MAbs; 2018; 10(6):922-933. PubMed ID: 29958062
[TBL] [Abstract][Full Text] [Related]
2. The NISTmAb Reference Material 8671 value assignment, homogeneity, and stability.
Schiel JE; Turner A; Mouchahoir T; Yandrofski K; Telikepalli S; King J; DeRose P; Ripple D; Phinney K
Anal Bioanal Chem; 2018 Mar; 410(8):2127-2139. PubMed ID: 29411089
[TBL] [Abstract][Full Text] [Related]
3. Qualification of NISTmAb charge heterogeneity control assays.
Turner A; Schiel JE
Anal Bioanal Chem; 2018 Mar; 410(8):2079-2093. PubMed ID: 29423598
[TBL] [Abstract][Full Text] [Related]
4. Development of orthogonal NISTmAb size heterogeneity control methods.
Turner A; Yandrofski K; Telikepalli S; King J; Heckert A; Filliben J; Ripple D; Schiel JE
Anal Bioanal Chem; 2018 Mar; 410(8):2095-2110. PubMed ID: 29428991
[TBL] [Abstract][Full Text] [Related]
5. Physicochemical and functional comparability between the proposed biosimilar rituximab GP2013 and originator rituximab.
Visser J; Feuerstein I; Stangler T; Schmiederer T; Fritsch C; Schiestl M
BioDrugs; 2013 Oct; 27(5):495-507. PubMed ID: 23649935
[TBL] [Abstract][Full Text] [Related]
6. The NISTmAb Reference Material 8671 lifecycle management and quality plan.
Schiel JE; Turner A
Anal Bioanal Chem; 2018 Mar; 410(8):2067-2078. PubMed ID: 29430600
[TBL] [Abstract][Full Text] [Related]
7. Cutting-edge mass spectrometry characterization of originator, biosimilar and biobetter antibodies.
Beck A; Debaene F; Diemer H; Wagner-Rousset E; Colas O; Van Dorsselaer A; Cianférani S
J Mass Spectrom; 2015 Feb; 50(2):285-97. PubMed ID: 25800010
[TBL] [Abstract][Full Text] [Related]
8. An Integrated Approach for a Structural and Functional Evaluation of Biosimilars: Implications for Erythropoietin.
Gianoncelli A; Bonini SA; Bertuzzi M; Guarienti M; Vezzoli S; Kumar R; Delbarba A; Mastinu A; Sigala S; Spano P; Pani L; Pecorelli S; Memo M
BioDrugs; 2015 Aug; 29(4):285-300. PubMed ID: 26334631
[TBL] [Abstract][Full Text] [Related]
9. Identification of multiple serine to asparagine sequence variation sites in an intended copy product of LUCENTIS® by mass spectrometry.
Griaud F; Winter A; Denefeld B; Lang M; Hensinger H; Straube F; Sackewitz M; Berg M
MAbs; 2017; 9(8):1337-1348. PubMed ID: 28846476
[TBL] [Abstract][Full Text] [Related]
10. Hydrophilic Interaction Chromatography Hyphenated with Mass Spectrometry: A Powerful Analytical Tool for the Comparison of Originator and Biosimilar Therapeutic Monoclonal Antibodies at the Middle-up Level of Analysis.
D'Atri V; Fekete S; Beck A; Lauber M; Guillarme D
Anal Chem; 2017 Feb; 89(3):2086-2092. PubMed ID: 28208257
[TBL] [Abstract][Full Text] [Related]
11. Glycosylation of biosimilars: Recent advances in analytical characterization and clinical implications.
Duivelshof BL; Jiskoot W; Beck A; Veuthey JL; Guillarme D; D'Atri V
Anal Chim Acta; 2019 Dec; 1089():1-18. PubMed ID: 31627805
[TBL] [Abstract][Full Text] [Related]
12. Monoclonal antibodies biosimilarity assessment using transient isotachophoresis capillary zone electrophoresis-tandem mass spectrometry.
Gahoual R; Biacchi M; Chicher J; Kuhn L; Hammann P; Beck A; Leize-Wagner E; François YN
MAbs; 2014; 6(6):1464-73. PubMed ID: 25484058
[TBL] [Abstract][Full Text] [Related]
13. Characterization of Pharmaceutical IgG and Biosimilars Using Miniaturized Platforms and LC-MS/MS.
Wooding KM; Peng W; Mechref Y
Curr Pharm Biotechnol; 2016; 17(9):788-801. PubMed ID: 27033511
[TBL] [Abstract][Full Text] [Related]
14. QbD-guided pharmaceutical development of Pembrolizumab biosimilar candidate PSG-024 propelled to industry meeting primary requirements of comparability to Keytruda®.
Jaffar-Aghaei M; Khanipour F; Maghsoudi A; Sarvestani R; Mohammadian M; Maleki M; Havasi F; Rahmani H; Karagah AH; Kazemali MR
Eur J Pharm Sci; 2022 Jun; 173():106171. PubMed ID: 35378209
[TBL] [Abstract][Full Text] [Related]
15. Biophysical characterization and structure of the Fab fragment from the NIST reference antibody, RM 8671.
Karageorgos I; Gallagher ES; Galvin C; Gallagher DT; Hudgens JW
Biologicals; 2017 Nov; 50():27-34. PubMed ID: 28965821
[TBL] [Abstract][Full Text] [Related]
16. Comparison of originator and biosimilar monoclonal antibodies using HRMS, Fc affinity chromatography, and 2D-HPLC.
Reinders LMH; Klassen MD; Teutenberg T; Jaeger M; Schmidt TC
Anal Bioanal Chem; 2022 Sep; 414(23):6761-6769. PubMed ID: 35895102
[TBL] [Abstract][Full Text] [Related]
17. Comparison of originator and biosimilar therapeutic monoclonal antibodies using comprehensive two-dimensional liquid chromatography coupled with time-of-flight mass spectrometry.
Sorensen M; Harmes DC; Stoll DR; Staples GO; Fekete S; Guillarme D; Beck A
MAbs; 2016 Oct; 8(7):1224-1234. PubMed ID: 27362833
[TBL] [Abstract][Full Text] [Related]
18. Establishing analytical comparability for "biosimilars": filgrastim as a case study.
Rathore AS; Bhambure R
Anal Bioanal Chem; 2014 Oct; 406(26):6569-76. PubMed ID: 24866713
[TBL] [Abstract][Full Text] [Related]
19. The criticality of high-resolution N-linked carbohydrate assays and detailed characterization of antibody effector function in the context of biosimilar development.
Brady LJ; Velayudhan J; Visone DB; Daugherty KC; Bartron JL; Coon M; Cornwall C; Hinckley PJ; Connell-Crowley L
MAbs; 2015; 7(3):562-70. PubMed ID: 25898160
[TBL] [Abstract][Full Text] [Related]
20. Comprehensive Physicochemical and Biological Characterization of the Proposed Biosimilar Darbepoetin Alfa, LBDE, and Its Originator Darbepoetin Alfa, NESP
Jeong YR; Jeong RU; Son JH; Kwon JC; Jung S; Song MA; Hwang JA; Lee GM
BioDrugs; 2018 Apr; 32(2):153-168. PubMed ID: 29556960
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
