关注
Hiten Gutka
Hiten Gutka
Senior Scientist Biologics Drug Product Development
在 celgene.com 的电子邮件经过验证
标题
引用次数
引用次数
年份
Rational selection, criticality assessment, and tiering of quality attributes and test methods for analytical similarity evaluation of biosimilars
K Vandekerckhove, A Seidl, H Gutka, M Kumar, G Gratzl, D Keire, ...
The AAPS journal 20, 1-9, 2018
452018
A systematic review of commercial high concentration antibody drug products approved in the US: formulation composition, dosage form design and primary packaging considerations
I Ghosh, H Gutka, ME Krause, R Clemens, RS Kashi
MAbs 15 (1), 2205540, 2023
252023
glpX Gene of Mycobacterium tuberculosis: Heterologous Expression, Purification, and Enzymatic Characterization of the Encoded Fructose 1,6-bisphosphatase II
HJ Gutka, K Rukseree, PR Wheeler, SG Franzblau, F Movahedzadeh
Applied biochemistry and biotechnology 164, 1376-1389, 2011
222011
Statistical approaches to assess biosimilarity from analytical data
R Burdick, T Coffey, H Gutka, G Gratzl, HD Conlon, CT Huang, M Boyne, ...
The AAPS journal 19, 4-14, 2017
202017
Glpx gene in Mycobacterium tuberculosis is required for in vitro gluconeogenic growth and in vivo survival
HJ Gutka, Y Wang, SG Franzblau, F Movahedzadeh
PLoS One 10 (9), e0138436, 2015
202015
Buffered formulations of bevacizumab
M Taddei, J Cheung, H Gutka
US Patent App. 16/066,464, 2019
102019
A two-step strategy for the complementation of M: tuberculosis mutants
F Movahedzadeh, R Frita, HJ Gutka
Genetics and molecular biology 34, 286-289, 2011
92011
Structures of the Mycobacterium tuberculosis GlpX protein (class II fructose-1, 6-bisphosphatase): implications for the active oligomeric state, catalytic mechanism and citrate …
NM Wolf, HJ Gutka, F Movahedzadeh, C Abad-Zapatero
Acta Crystallographica Section D: Structural Biology 74 (4), 321-331, 2018
82018
Enzymatic Characterization of Fructose 1,6-Bisphosphatase II from Francisella tularensis, an Essential Enzyme for Pathogenesis
HJ Gutka, NM Wolf, JMG Bondoc, F Movahedzadeh
Applied biochemistry and biotechnology 183, 1439-1454, 2017
82017
Crystallization and preliminary X-ray characterization of the glpX-encoded class II fructose-1, 6-bisphosphatase from Mycobacterium tuberculosis
HJ Gutka, SG Franzblau, F Movahedzadeh, C Abad-Zapatero
Acta Crystallographica Section F: Structural Biology and Crystallization …, 2011
82011
Biosimilars: regulatory, clinical, and biopharmaceutical development
HJ Gutka, H Yang, S Kakar
Springer, 2018
72018
Structural and biochemical characterization of the class II fructose-1, 6-bisphosphatase from Francisella tularensis
AI Selezneva, HJ Gutka, NM Wolf, F Qurratulain, F Movahedzadeh, ...
Acta Crystallographica Section F: Structural Biology Communications 76 (11 …, 2020
42020
A systematic review of commercial high concentration antibody drug products approved in the US: formulation composition, dosage form design and primary packaging considerations …
I Ghosh, H Gutka, ME Krause, R Clemens, RS Kashi
DOI 10 (19420862.2023), 2205540, 0
4
Current trends and advances in bulk crystallization and freeze-drying of biopharmaceuticals
H Gutka, K Prasad
Lyophilized Biologics and Vaccines: Modality-Based Approaches, 299-317, 2015
32015
Buffer formulations for enhanced antibody stability
H Gutka, M Taddei, J Cheung
US Patent 11,285,210, 2022
22022
Rv0100, a proposed acyl carrier protein in Mycobacterium tuberculosis: expression, purification and crystallization
JMG Bondoc, HJ Gutka, MM Almutairi, R Patwell, MW Rutter, NM Wolf, ...
Acta Crystallographica Section F: Structural Biology Communications 75 (10 …, 2019
12019
Rv0100: An essential acyl carrier protein from M. tuberculosis important in dormancy
HJ Gutka, JMG Bondoc, R Patwell, S Khan, EM Grzelak, R Goswami, ...
Plos one 19 (6), e0304876, 2024
2024
New structures of Class II Fructose-1,6-Bisphosphatase from Francisella tularensis provide a framework for a novel catalytic mechanism for the entire class
AI Selezneva, LNM Harding, HJ Gutka, F Movahedzadeh, ...
Plos one 18 (6), e0274723, 2023
2023
New structures of Class II Fructose-1,6-Bisphosphatase from Francisella tularensis suggest a novel catalytic mechanism for the entire Class
AI Selezneva, LNM Harding, HJ Gutka, F Movahedzadeh, ...
bioRxiv, 2022.09. 05.506711, 2022
2022
Buffer formulations for enhanced antibody stability
H GUTKA, M TADDEI, J CHEUNG
2017
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