This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
V. Jairath and B. G. Feagan, Global burden of inflammatory bowel disease, Lancet Gastroenterol. Hepatol. 5(1) (2020) 2–3; https://doi.org/10.1016/S2468-1253(19)30358-9Search in Google Scholar
R. Ratih, M. Asmari, A. M. Abdel-Megied, F. Elbarbry and S. El Deeb, Biosimilars: review of regulatory, manufacturing, analytical aspects and beyond, Microchem. J.165 (2021) Article ID 106143 (10 pages); https://doi.org/10.1016/j.microc.2021.106143Search in Google Scholar
G. R. D’Haens and S. van Deventer, 25 years of anti-TNF treatment for inflammatory bowel disease: lessons from the past and a look to the future, Gut70 (2021) 1396–1405; http://dx.doi.org/10.1136/gutjnl-2019-320022Search in Google Scholar
R. Atreya, M. F. Neurath and B. Siegmund, Personalizing treatment in IBD: Hype or reality in 2020? Can we predict response to anti-TNF?, Front Med. (Lausanne)7 (2020) Article ID 517 (14 pages); https://doi.org/10.3389/fmed.2020.00517Search in Google Scholar
M. Sajid and J. Płotka-Wasylka, Green analytical chemistry metrics: a review, Talanta238 (2022) 123046; https://doi.org/10.1016/j.talanta.2021.123046Search in Google Scholar
S. M. Singh, R. Furman, R. K. Singh, G. Balakrishnan, N. Chennamsetty, L. Tao and Z. Li, Size exclusion chromatography for the characterization and quality control of biologics, J. Liq. Chromatogr. Relat. Technol.44(5-6) (2021) 265–278; https://doi.org/10.1080/10826076.2021.1979582Search in Google Scholar
European Directorate for the Quality of Medicines & HealthCare (EDQM) Council of Europe, Technical Guide for the Elaboration of Monographs on Synthetic Peptides and Recombinant DNA Proteins, in European Pharmacopoeia, 2nd revision ed., Strasbourg 2018, pp. 5–15; https://www.edqm.eu/en/d/67217Search in Google Scholar
A. Goyon, S. Fekete, A. Beck, J.-L. Veuthey and D. Guillarme, Unraveling the mysteries of modern size exclusion chromatography – the way to achieve confident characterization of therapeutic proteins, J. Chromatogr. B1092 (2018) 368–378; https://doi.org/10.1016/j.jchromb.2018.06.029Search in Google Scholar
T. Kohno, L.-T. T. Tam, S. R. Stevens and J. S. Louie, Binding characteristics of tumor necrosis factor receptor-Fc fusion proteins vs anti-tumor necrosis factor mAbs, J. Investig. Dermatol. Symp. Proc.12(1) (2007) 5–8; https://doi.org/10.1038/sj.jidsymp.5650034Search in Google Scholar
N. Lee, I. J. J. Lee, H. Yang, S. Baek, S. Kim, S. Kim, T. Lee, D. Song and G. Park, Evaluation of similar quality attribute characteristics in SB5 and reference product of adalimumab, MAbs11(1) (2018) 129–144; https://doi.org/10.1080/19420862.2018.1530920Search in Google Scholar
S. Schreiber, K. Yamamoto, R. Muniz and T. Iwura, Physicochemical analysis and biological characterization of FKB327 as a biosimilar to adalimumab, Pharmacol. Res. Perspect8(3) (2020) e00604 (13 pages); https://doi.org/10.1002/prp2.604Search in Google Scholar
Y. Jiang, T. Arora, S. Klakamp, J. Davis, Y. A. Chandrasekher, G. Young, Y. Du, B. Yu and K. J. Miller, Demonstration of physicochemical and functional similarity of biosimilar adalimumabaqvh to adalimumab, Drugs in R&D23 (2023) 377–395; https://doi.org/10.1007/s40268-023-00437-3Search in Google Scholar
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH guideline Q2(R2) on validation of analytical procedures; https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-q2r2-validation-analytical-procedures-step-2b_en.pdf; last access date September 22, 2023.Search in Google Scholar
F. Pena-Pereira, W. Wojnowski and M. Tobiszewski, AGREE—Analytical GREEnness metric approach and software, Anal. Chem.92(14) (2020) 10076–10082; https://doi.org/10.1021/acs.analchem.0c01887Search in Google Scholar
The United States Pharmacopeia and The National Formulary, 2021 (USP-NF2021), United States Pharmacopeial Convention, Rockville, MD, 2021.Search in Google Scholar
C. Nowak, J. K. Cheung, S. M. Dellatore, A. Katiyar, R. Bhat, J. Sun, G. Ponniah, A. Neill, B. Mason, A. Beck, and H. Liu, Forced degradation of recombinant monoclonal antibodies: A practical guide, MAbs9(8) (2017) 1217–1230; https://doi:10.1080/19420862.2017.1368602Search in Google Scholar
L. A. Hassan, M. A. Al-Ghobashy and S. S. Abbas, Evaluation of the pattern and kinetics of degradation of adalimumab using a stability-indicating orthogonal testing protocol, Biomed. Chromatogr.33(12) (2019) e4676; https://doi:10.1002/bmc.4676Search in Google Scholar
A. B. Shabestari, S. M. Mostafavi and H. Malekzadeh, Force degradation comparative study on biosimilar adalimumab and Humira, Rev. Latinoam. Hipertens.13(6) (2018) 496–508.Search in Google Scholar
F. Füssl, A. Trappe, K. Cook, K. Scheffler, O. Fitzgerald and J. Bones, Comprehensive characterisation of the heterogeneity of adalimumab via charge variant analysis hyphenated on-line to native high resolution Orbitrap mass spectrometry, MAbs11(1) (2019) 116–128; https://doi.org/10.1080/19420862.2018.1531664Search in Google Scholar
R. E. Hariry, R. V. Barenji and A. Azizi, Toward Pharma 4.0 in Drug Discovery, in Industry 4.0. Emerging Trends in Mechatronics (Ed. A. Azizi, R. V. Barenji) Springer, Singapore 2023; https://doi.org/10.1007/978-981-19-2012-7_10Search in Google Scholar
J. Kovačić, M.-L. Jeličić, D. Amidžić Klarić and A. Mornar, Green solid-phase (micro)extraction of andrographolides’ from human plasma samples followed by UHPLC-DAD-QqQ-MS/MS analysis, Separations10(2) (2023) Article ID 69 (18 pages); https://doi.org/10.3390/separations10020069Search in Google Scholar