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1.
Protein Engineering and HDX Identify Structural Regions of G-CSF Critical to Its Stability and Aggregation.
Mol Pharm
; 19(2): 616-629, 2022 02 07.
Artículo
en Inglés
| MEDLINE | ID: mdl-34965730
2.
WHO informal consultation on revision of guidelines on evaluation of similar biotherapeutic products, virtual meeting, 30 June - 2 July 2021.
Biologicals
; 76: 1-9, 2022 Apr.
Artículo
en Inglés
| MEDLINE | ID: mdl-35466023
3.
The impact of thioredoxin reduction of allosteric disulfide bonds on the therapeutic potential of monoclonal antibodies.
J Biol Chem
; 294(51): 19616-19634, 2019 12 20.
Artículo
en Inglés
| MEDLINE | ID: mdl-31727737
4.
WHO implementation workshop on guidelines on procedures and data requirements for changes to approved biotherapeutic products, Seoul, Republic of Korea, 25-26 June 2019.
Biologicals
; 65: 50-59, 2020 May.
Artículo
en Inglés
| MEDLINE | ID: mdl-31959504
5.
Reprint of "Anti-therapeutic antibodies and their clinical impact in patients treated with the TNF antagonist adalimumab".
Cytokine
; 101: 70-77, 2018 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-29174881
6.
WHO informal consultation on development of guidelines on procedures and data requirements for changes to approved biotherapeutic products, Seoul, Republic of Korea, 27-28 April 2017.
Biologicals
; 52: 83-91, 2018 Mar.
Artículo
en Inglés
| MEDLINE | ID: mdl-29289489
7.
Influence of Escherichia coli chaperone DnaK on protein immunogenicity.
Immunology
; 150(3): 343-355, 2017 03.
Artículo
en Inglés
| MEDLINE | ID: mdl-27859059
8.
Anti-therapeutic antibodies and their clinical impact in patients treated with the TNF antagonist adalimumab.
Cytokine
; 96: 16-23, 2017 08.
Artículo
en Inglés
| MEDLINE | ID: mdl-28279855
9.
Immunogenicity assessment of biotherapeutic products: An overview of assays and their utility.
Biologicals
; 43(5): 298-306, 2015 Sep.
Artículo
en Inglés
| MEDLINE | ID: mdl-26144595
10.
Biosimilars: what clinicians should know.
Blood
; 120(26): 5111-7, 2012 Dec 20.
Artículo
en Inglés
| MEDLINE | ID: mdl-23093622
11.
WHO International Standards and reference preparations for cytokines and growth factors.
Cytokine
; 123: 154797, 2019 11.
Artículo
en Inglés
| MEDLINE | ID: mdl-31401403
12.
Immunoglobulin G1 and immunoglobulin G4 antibodies in multiple sclerosis patients treated with IFNß interact with the endogenous cytokine and activate complement.
Clin Immunol
; 148(2): 177-85, 2013 Aug.
Artículo
en Inglés
| MEDLINE | ID: mdl-23770627
13.
Severity of the TGN1412 trial disaster cytokine storm correlated with IL-2 release.
Br J Clin Pharmacol
; 76(2): 299-315, 2013 Aug.
Artículo
en Inglés
| MEDLINE | ID: mdl-23701319
14.
WHO guidelines on biosimilars: Toward improved access to safe and effective products.
Ann N Y Acad Sci
; 1521(1): 96-103, 2023 03.
Artículo
en Inglés
| MEDLINE | ID: mdl-36694455
15.
Freeze drying formulation using microscale and design of experiment approaches: a case study using granulocyte colony-stimulating factor.
Biotechnol Lett
; 34(4): 641-8, 2012 Apr.
Artículo
en Inglés
| MEDLINE | ID: mdl-22187075
16.
Impact of Formulation Choices on the Freeze-Drying of an Interleukin-6 Reference Material.
Front Mol Biosci
; 9: 868460, 2022.
Artículo
en Inglés
| MEDLINE | ID: mdl-35860358
17.
2021 White Paper on Recent Issues in Bioanalysis: ISR for Biomarkers, Liquid Biopsies, Spectral Cytometry, Inhalation/Oral & Multispecific Biotherapeutics, Accuracy/LLOQ for Flow Cytometry (Part 2 - Recommendations on Biomarkers/CDx Assays Development & Validation, Cytometry Validation & Innovation, Biotherapeutics PK LBA Regulated Bioanalysis, Critical Reagents & Positive Controls Generation).
Bioanalysis
; 14(10): 627-692, 2022 May.
Artículo
en Inglés
| MEDLINE | ID: mdl-35578974
18.
Endothelial cells co-stimulate peripheral blood mononuclear cell responses to monoclonal antibody TGN1412 in culture.
Cytokine
; 55(1): 141-51, 2011 Jul.
Artículo
en Inglés
| MEDLINE | ID: mdl-21493088
19.
Intended use of reference products & WHO International Standards/Reference Reagents in the development of similar biological products (biosimilars).
Biologicals
; 39(5): 262-5, 2011 Sep.
Artículo
en Inglés
| MEDLINE | ID: mdl-21880508
20.
WHO/KFDA joint workshop on implementing WHO guidelines on evaluating similar biotherapeutic products, Seoul, Republic of Korea 24-26 August, 2010.
Biologicals
; 39(5): 349-57, 2011 Sep.
Artículo
en Inglés
| MEDLINE | ID: mdl-21906959