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Characterization of Subvisible Particles in Biotherapeutic Prefilled Syringes: The Role of Polysorbate and Protein on the Formation of Silicone Oil and Protein Subvisible Particles After Drop Shock

Journal of pharmaceutical sciences, 2020-01, Vol.109 (1), p.640-645

2020

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Analytical and Functional Similarity of the Biosimilar Candidate ABP 654 to Ustekinumab Reference Product

Drugs in R&D, 2023-12, Vol.23 (4), p.421-438

2023

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A critical review of analytical methods for subvisible and visible particles

Current pharmaceutical biotechnology, 2009-06, Vol.10 (4), p.373-381

2009

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Separation and characterization of protein aggregates and particles by field flow fractionation

Current pharmaceutical biotechnology, 2009-06, Vol.10 (4), p.382-390

2009

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Analytical and Functional Similarity of Aflibercept Biosimilar ABP 938 with Aflibercept Reference Product

Ophthalmology and therapy, 2024-05, Vol.13 (5), p.1303-1320

2024

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Non-Destructive Analysis of Subvisible Particles with Mie-Scattering-Based Light Sheet Technology: System Development

Journal of pharmaceutical sciences, 2024-09, Vol.113 (9), p.2817-2825

2024

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Ion‐specific modulation of protein interactions: Anion‐induced, reversible oligomerization of a fusion protein

Protein science, 2009-01, Vol.18 (1), p.169-179

2009

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Assessing Analytical Similarity of Proposed Amgen Biosimilar ABP 501 to Adalimumab

BioDrugs : clinical immunotherapeutics, biopharmaceuticals, and gene therapy, 2016-08, Vol.30 (4), p.321-338

2016

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Characterizing Reversible Protein Association at Moderately High Concentration Via Composition-Gradient Static Light Scattering

Journal of pharmaceutical sciences, 2016-08, Vol.105 (8), p.2310-2318

2016

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Method to Determine Syringe Silicone Oil Layer Heterogeneity and Investigation of its Impact on Product Particle Counts

Journal of pharmaceutical sciences, 2020-11, Vol.109 (11), p.3292-3299

2020

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In Situ Quantification of Polysorbate in Pharmaceutical Samples of Therapeutic Proteins by Hydrodynamic Profiling by NMR Spectroscopy

Analytical chemistry (Washington), 2019-06, Vol.91 (12), p.7807-7811

2019

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Analytical and functional similarity of Amgen biosimilar ABP 215 to bevacizumab

mAbs, 2018-05, Vol.10 (4), p.678-691

2018

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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

Journal of pharmaceutical sciences, 2022-05, Vol.111 (5), p.1280-1291

2022

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Industry Perspective on the Use and Characterization of Polysorbates for Biopharmaceutical Products Part 2: Survey Report on Control Strategy Preparing for the Future

Journal of pharmaceutical sciences, 2022-11, Vol.111 (11), p.2955-2967

2022

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Analytical and functional similarity of biosimilar ABP 798 with rituximab reference product

Biologicals, 2020-11, Vol.68, p.79-91

2020

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Analytical Similarity Assessment of ABP 959 in Comparison with Eculizumab Reference Product

BioDrugs : clinical immunotherapeutics, biopharmaceuticals, and gene therapy, 2021-09, Vol.35 (5), p.563-577

2021

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Silicone Oil Particles in Prefilled Syringes With Human Monoclonal Antibody, Representative of Real-World Drug Products, Did Not Increase Immunogenicity in In Vivo and In Vitro Model Systems

Journal of pharmaceutical sciences, 2020-01, Vol.109 (1), p.845-853

2020

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Evaluating Clinical Safety and Analytical Impact of Subvisible Silicone Oil Particles in Biopharmaceutical Products

Journal of pharmaceutical sciences, 2024-05, Vol.113 (5), p.1401-1414

2024

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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

Journal of pharmaceutical sciences, 2020-01, Vol.109 (1), p.830-844

2020

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Classification of glass particles in parenteral product vials by visual, microscopic, and spectroscopic methods

PDA journal of pharmaceutical science and technology, 2014-07, Vol.68 (4), p.362-372

2014

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Monitoring ceramic hydroxyapatite media degradation using dynamic image analysis and uniaxial confined bulk compression

Biotechnology journal, 2012-10, Vol.7 (10), p.1288-1296

2012

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Transactions on Large-Scale Data- and Knowledge-Centered Systems VI: Special Issue on Database- and Expert-Systems Applications

2012, 2012

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Field-Flow Fractionation in Therapeutic Protein Development

Field-Flow Fractionation in Biopolymer Analysis, 2011, p.73-88

2011

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Analytical Methods to Measure Subvisible Particulates

Analysis of Aggregates and Particles in Protein Pharmaceuticals, 2012, p.85-115

2012

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Characterization of Subvisible Particles in Biotherapeutic Prefilled Syringes: The Role of Polysorbate and Protein on the Formation of Silicone Oil and Protein Subvisible Particles After Drop Shock

Analytical and Functional Similarity of the Biosimilar Candidate ABP 654 to Ustekinumab Reference Product

A critical review of analytical methods for subvisible and visible particles

Separation and characterization of protein aggregates and particles by field flow fractionation

Analytical and Functional Similarity of Aflibercept Biosimilar ABP 938 with Aflibercept Reference Product

Non-Destructive Analysis of Subvisible Particles with Mie-Scattering-Based Light Sheet Technology: System Development

Ion‐specific modulation of protein interactions: Anion‐induced, reversible oligomerization of a fusion protein

Assessing Analytical Similarity of Proposed Amgen Biosimilar ABP 501 to Adalimumab

Characterizing Reversible Protein Association at Moderately High Concentration Via Composition-Gradient Static Light Scattering

Method to Determine Syringe Silicone Oil Layer Heterogeneity and Investigation of its Impact on Product Particle Counts

In Situ Quantification of Polysorbate in Pharmaceutical Samples of Therapeutic Proteins by Hydrodynamic Profiling by NMR Spectroscopy

Analytical and functional similarity of Amgen biosimilar ABP 215 to bevacizumab

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

Industry Perspective on the Use and Characterization of Polysorbates for Biopharmaceutical Products Part 2: Survey Report on Control Strategy Preparing for the Future

Analytical and functional similarity of biosimilar ABP 798 with rituximab reference product

Analytical Similarity Assessment of ABP 959 in Comparison with Eculizumab Reference Product

Silicone Oil Particles in Prefilled Syringes With Human Monoclonal Antibody, Representative of Real-World Drug Products, Did Not Increase Immunogenicity in In Vivo and In Vitro Model Systems

Evaluating Clinical Safety and Analytical Impact of Subvisible Silicone Oil Particles in Biopharmaceutical Products

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

Subvisible (2–100 μm) particle analysis during biotherapeutic drug product development: Part 2, experience with the application of subvisible particle analysis

Classification of glass particles in parenteral product vials by visual, microscopic, and spectroscopic methods

Monitoring ceramic hydroxyapatite media degradation using dynamic image analysis and uniaxial confined bulk compression

Transactions on Large-Scale Data- and Knowledge-Centered Systems VI: Special Issue on Database- and Expert-Systems Applications

Field-Flow Fractionation in Therapeutic Protein Development

Analytical Methods to Measure Subvisible Particulates

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