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Hiten Gutka
Hiten Gutka
Senior Scientist Biologics Drug Product Development
Verified email at celgene.com
Title
Cited by
Cited by
Year
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
442018
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
172015
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
152023
Buffered formulations of bevacizumab
M Taddei, J Cheung, H Gutka
US Patent App. 16/066,464, 2019
92019
Biosimilars: regulatory, clinical, and biopharmaceutical development
HJ Gutka, H Yang, S Kakar
Springer, 2018
82018
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
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
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
72017
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
72011
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
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
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
Rv0100, a proposed acyl carrier protein in Mycobacterium tuberculosis: expression, purification and crystallization. Corrigendum
JMG Bondoc, HJ Gutka, MM Almutairi, R Patwell, MW Rutter, NM Wolf, ...
Acta Crystallographica Section F: Structural Biology Communications 76 (4 …, 2020
2020
Buffer formulations for enhanced antibody stability
H GUTKA, M TADDEI, J CHEUNG
2017
Case Studies and Examples of Biopharmaceutical Modalities Processed by Bulk Crystallization or Bulk Freeze-Drying
H Gutka, K Prasad
Lyophilized Biologics and Vaccines: Modality-Based Approaches, 319-337, 2015
2015
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