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 | 45 | 2018 |
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 | 25 | 2023 |
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 | 22 | 2011 |
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 | 20 | 2017 |
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 | 20 | 2015 |
Buffered formulations of bevacizumab M Taddei, J Cheung, H Gutka US Patent App. 16/066,464, 2019 | 10 | 2019 |
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 | 9 | 2011 |
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 | 8 | 2018 |
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 | 8 | 2017 |
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 | 8 | 2011 |
Biosimilars: regulatory, clinical, and biopharmaceutical development HJ Gutka, H Yang, S Kakar Springer, 2018 | 7 | 2018 |
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 | 4 | 2020 |
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 | 3 | 2015 |
Buffer formulations for enhanced antibody stability H Gutka, M Taddei, J Cheung US Patent 11,285,210, 2022 | 2 | 2022 |
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 | 1 | 2019 |
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 |