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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.
Subvisible (2-100 µm) particle analysis during biotherapeutic drug product development: Part 2, experience with the application of subvisible particle analysis.
Biologicals;
43(6): 457-73, 2015 Nov.
Artículo
en Inglés
| MEDLINE | ID: mdl-26324466
3.
Challenges in the analysis of pharmaceutical lentiviral vector products by orthogonal and complementary physical (nano)particle characterization techniques.
Eur J Pharm Biopharm;
200: 114340, 2024 Jul.
Artículo
en Inglés
| MEDLINE | ID: mdl-38797222
4.
Monitoring of Visible Particles in Parenteral Products by Manual Visual Inspection-Reassessing Size Threshold and Other Particle Characteristics that Define Particle Visibility.
J Pharm Sci;
113(3): 616-624, 2024 03.
Artículo
en Inglés
| MEDLINE | ID: mdl-37802369
5.
Industry perspective on a holistic container closure integrity approach to parenteral combination products.
Eur J Pharm Biopharm;
194: 20-35, 2024 Jan.
Artículo
en Inglés
| MEDLINE | ID: mdl-37981109
6.
Comparison of the Protective Effect of Polysorbates, Poloxamer and Brij on Antibody Stability Against Different Interfaces.
J Pharm Sci;
112(11): 2853-2862, 2023 Nov.
Artículo
en Inglés
| MEDLINE | ID: mdl-37295604
7.
Surface-Induced Protein Aggregation and Particle Formation in Biologics: Current Understanding of Mechanisms, Detection and Mitigation Strategies.
J Pharm Sci;
112(2): 377-385, 2023 02.
Artículo
en Inglés
| MEDLINE | ID: mdl-36223809
8.
Combining Machine Learning and Backgrounded Membrane Imaging: A Case Study in Comparing and Classifying Different Types of Biopharmaceutically Relevant Particles.
J Pharm Sci;
111(9): 2422-2434, 2022 09.
Artículo
en Inglés
| MEDLINE | ID: mdl-35661758
9.
Particles in Biopharmaceutical Formulations, Part 2: An Update on Analytical Techniques and Applications for Therapeutic Proteins, Viruses, Vaccines and Cells.
J Pharm Sci;
111(4): 933-950, 2022 04.
Artículo
en Inglés
| MEDLINE | ID: mdl-34919969
10.
A Multicompany Survey Study for Helium Leak Container Closure Integrity Test.
PDA J Pharm Sci Technol;
76(3): 216-235, 2022.
Artículo
en Inglés
| MEDLINE | ID: mdl-34782444
11.
Industry Perspective on the use and Characterization of Polysorbates for Biopharmaceutical Products Part 1: Survey Report on Current State and Common Practices for Handling and Control of Polysorbates.
J Pharm Sci;
111(5): 1280-1291, 2022 05.
Artículo
en Inglés
| MEDLINE | ID: mdl-35192858
12.
Industry Perspective on the Use and Characterization of Polysorbates for Biopharmaceutical Products Part 2: Survey Report on Control Strategy Preparing for the Future.
J Pharm Sci;
111(11): 2955-2967, 2022 11.
Artículo
en Inglés
| MEDLINE | ID: mdl-36002077
13.
Polysorbate Degradation and Particle Formation in a High Concentration mAb: Formulation Strategies to Minimize Effect of Enzymatic Polysorbate Degradation.
J Pharm Sci;
110(9): 3313-3323, 2021 09.
Artículo
en Inglés
| MEDLINE | ID: mdl-34077768
14.
Micelle Driven Oxidation Mechansim and Novel Oxidation Markers for Different Grades of Polysorbate 20 and 80.
J Pharm Sci;
109(10): 3064-3077, 2020 10.
Artículo
en Inglés
| MEDLINE | ID: mdl-32653599
15.
Backgrounded Membrane Imaging (BMI) for High-Throughput Characterization of Subvisible Particles During Biopharmaceutical Drug Product Development.
J Pharm Sci;
109(1): 264-276, 2020 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-30914272
16.
What Makes Polysorbate Functional? Impact of Polysorbate 80 Grade and Quality on IgG Stability During Mechanical Stress.
J Pharm Sci;
109(1): 871-880, 2020 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-31614127
17.
Novel High-Throughput Assay for Polysorbate Quantification in Biopharmaceutical Products by Using the Fluorescent Dye DiI.
J Pharm Sci;
109(1): 646-655, 2020 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-31606542
18.
A Multicompany Assessment of Submicron Particle Levels by NTA and RMM in a Wide Range of Late-Phase Clinical and Commercial Biotechnology-Derived Protein Products.
J Pharm Sci;
109(1): 830-844, 2020 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-31647951
19.
Factors Influencing Polysorbate's Sensitivity Against Enzymatic Hydrolysis and Oxidative Degradation.
J Pharm Sci;
108(6): 2022-2032, 2019 06.
Artículo
en Inglés
| MEDLINE | ID: mdl-30639738
20.
Trends on Analytical Characterization of Polysorbates and Their Degradation Products in Biopharmaceutical Formulations.
J Pharm Sci;
106(7): 1722-1735, 2017 07.
Artículo
en Inglés
| MEDLINE | ID: mdl-28302541