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1.
An Interlaboratory Study to Identify Potential Visible Protein-Like Particle Standards.
AAPS PharmSciTech
; 24(1): 18, 2022 Dec 16.
Artículo
en Inglés
| MEDLINE | ID: mdl-36526853
2.
The NISTmAb Reference Material 8671 value assignment, homogeneity, and stability.
Anal Bioanal Chem
; 410(8): 2127-2139, 2018 Mar.
Artículo
en Inglés
| MEDLINE | ID: mdl-29411089
3.
Development of orthogonal NISTmAb size heterogeneity control methods.
Anal Bioanal Chem
; 410(8): 2095-2110, 2018 Mar.
Artículo
en Inglés
| MEDLINE | ID: mdl-29428991
4.
Morphologically-Directed Raman Spectroscopy as an Analytical Method for Subvisible Particle Characterization in Therapeutic Protein Product Quality.
Sci Rep
; 13(1): 20473, 2023 11 22.
Artículo
en Inglés
| MEDLINE | ID: mdl-37993487
5.
Recent Achievements and Current Interests in Research on the Characterization and Quality Control of Biopharmaceuticals in Japan.
J Pharm Sci
; 109(5): 1652-1661, 2020 05.
Artículo
en Inglés
| MEDLINE | ID: mdl-31927040
6.
Development of Protein-Like Reference Material for Semiquantitatively Monitoring Visible Proteinaceous Particles in Biopharmaceuticals.
PDA J Pharm Sci Technol
; 73(5): 418-432, 2019.
Artículo
en Inglés
| MEDLINE | ID: mdl-31209163
7.
Variable Threshold Method for Determining the Boundaries of Imaged Subvisible Particles.
J Pharm Sci
; 106(6): 1499-1507, 2017 06.
Artículo
en Inglés
| MEDLINE | ID: mdl-28209364
8.
Characterization of the physical stability of a lyophilized IgG1 mAb after accelerated shipping-like stress.
J Pharm Sci
; 104(2): 495-507, 2015 Feb.
Artículo
en Inglés
| MEDLINE | ID: mdl-25522000
9.
Physical characterization and in vitro biological impact of highly aggregated antibodies separated into size-enriched populations by fluorescence-activated cell sorting.
J Pharm Sci
; 104(5): 1575-91, 2015 May.
Artículo
en Inglés
| MEDLINE | ID: mdl-25753756
10.
Structural characterization of IgG1 mAb aggregates and particles generated under various stress conditions.
J Pharm Sci
; 103(3): 796-809, 2014 Mar.
Artículo
en Inglés
| MEDLINE | ID: mdl-24452866
11.
Probing structurally altered and aggregated states of therapeutically relevant proteins using GroEL coupled to bio-layer interferometry.
Protein Sci
; 23(10): 1461-78, 2014 Oct.
Artículo
en Inglés
| MEDLINE | ID: mdl-25043635
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