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Development of a Microflow Digital Imaging Assay to Characterize Protein Particulates During Storage of a High Concentration IgG1 Monoclonal Antibody Formulation

Journal of pharmaceutical sciences, 2010-08, Vol.99 (8), p.3343-3361

2010

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Factors Influencing Polysorbate's Sensitivity Against Enzymatic Hydrolysis and Oxidative Degradation

Journal of pharmaceutical sciences, 2019-06, Vol.108 (6), p.2022-2032

2019

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Real-Time Observation of Protein Aggregation at Liquid-Liquid Interfaces in a Microfluidic Device

Small (Weinheim an der Bergstrasse, Germany), 2024-08, p.e2401085

2024

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A comparison of Polysorbates and Alternative Surfactants for Interfacial Stress Protection and Mitigation of Fatty Acid Particle Formation in the Presence of an Esterase

Journal of pharmaceutical sciences, 2024-09, Vol.113 (9), p.2688-2698

2024

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Trends on Analytical Characterization of Polysorbates and Their Degradation Products in Biopharmaceutical Formulations

Journal of pharmaceutical sciences, 2017-07, Vol.106 (7), p.1722-1735

2017

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Micelle Driven Oxidation Mechansim and Novel Oxidation Markers for Different Grades of Polysorbate 20 and 80

Journal of pharmaceutical sciences, 2020-10, Vol.109 (10), p.3064-3077

2020

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Polysorbate Degradation and Particle Formation in a High Concentration mAb: Formulation Strategies to Minimize Effect of Enzymatic Polysorbate Degradation

Journal of pharmaceutical sciences, 2021-09, Vol.110 (9), p.3313-3323

2021

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Challenges in the analysis of pharmaceutical lentiviral vector products by orthogonal and complementary physical (nano)particle characterization techniques

European journal of pharmaceutics and biopharmaceutics, 2024-07, Vol.200, p.114340, Article 114340

2024

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Backgrounded Membrane Imaging (BMI) for High-Throughput Characterization of Subvisible Particles During Biopharmaceutical Drug Product Development

Journal of pharmaceutical sciences, 2020-01, Vol.109 (1), p.264-276

2020

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What Makes Polysorbate Functional? Impact of Polysorbate 80 Grade and Quality on IgG Stability During Mechanical Stress

Journal of pharmaceutical sciences, 2020-01, Vol.109 (1), p.871-880

2020

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Particles in Biopharmaceutical Formulations, Part 2: An Update on Analytical Techniques and Applications for Therapeutic Proteins, Viruses, Vaccines and Cells

Journal of pharmaceutical sciences, 2022-04, Vol.111 (4), p.933-950

2022

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Comparison of the Protective Effect of Polysorbates, Poloxamer and Brij on Antibody Stability Against Different Interfaces

Journal of pharmaceutical sciences, 2023-11, Vol.112 (11), p.2853-2862

2023

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Surface-Induced Protein Aggregation and Particle Formation in Biologics: Current Understanding of Mechanisms, Detection and Mitigation Strategies

Journal of pharmaceutical sciences, 2023-02, Vol.112 (2), p.377-385

2023

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Novel High-Throughput Assay for Polysorbate Quantification in Biopharmaceutical Products by Using the Fluorescent Dye DiI

Journal of pharmaceutical sciences, 2020-01, Vol.109 (1), p.646-655

2020

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Combining Machine Learning and Backgrounded Membrane Imaging: A Case Study in Comparing and Classifying Different Types of Biopharmaceutically Relevant Particles

Journal of pharmaceutical sciences, 2022-09, Vol.111 (9), p.2422-2434

2022

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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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Industry perspective on a holistic container closure integrity approach to parenteral combination products

European journal of pharmaceutics and biopharmaceutics, 2024-01, Vol.194, p.20-35

2024

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Monitoring of Visible Particles in Parenteral Products by Manual Visual Inspection—Reassessing Size Threshold and Other Particle Characteristics that Define Particle Visibility

Journal of pharmaceutical sciences, 2024-03, Vol.113 (3), p.616-624

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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Subvisible (2-100μm) Particle Analysis During Biotherapeutic Drug Product Development: Part 1, Considerations and Strategy

Journal of pharmaceutical sciences, 2015-06, Vol.104 (6), p.1899-1908

2015

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An Interlaboratory Study to Identify Potential Visible Protein-Like Particle Standards

AAPS PharmSciTech, 2022-12, Vol.24 (1), p.18-18, Article 18

2022

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A Multicompany Survey Study for Helium Leak Container Closure Integrity Test

PDA journal of pharmaceutical science and technology, 2022-05, Vol.76 (3), p.216-235

2022

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A Biopharmaceutical Industry Perspective on the Control of Visible Particles in Biotechnology-Derived Injectable Drug Products

PDA journal of pharmaceutical science and technology, 2016-07, Vol.70 (4), p.392-408

2016

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Development of a Microflow Digital Imaging Assay to Characterize Protein Particulates During Storage of a High Concentration IgG1 Monoclonal Antibody Formulation

Factors Influencing Polysorbate's Sensitivity Against Enzymatic Hydrolysis and Oxidative Degradation

Real-Time Observation of Protein Aggregation at Liquid-Liquid Interfaces in a Microfluidic Device

A comparison of Polysorbates and Alternative Surfactants for Interfacial Stress Protection and Mitigation of Fatty Acid Particle Formation in the Presence of an Esterase

Trends on Analytical Characterization of Polysorbates and Their Degradation Products in Biopharmaceutical Formulations

Micelle Driven Oxidation Mechansim and Novel Oxidation Markers for Different Grades of Polysorbate 20 and 80

Polysorbate Degradation and Particle Formation in a High Concentration mAb: Formulation Strategies to Minimize Effect of Enzymatic Polysorbate Degradation

Challenges in the analysis of pharmaceutical lentiviral vector products by orthogonal and complementary physical (nano)particle characterization techniques

Backgrounded Membrane Imaging (BMI) for High-Throughput Characterization of Subvisible Particles During Biopharmaceutical Drug Product Development

What Makes Polysorbate Functional? Impact of Polysorbate 80 Grade and Quality on IgG Stability During Mechanical Stress

Particles in Biopharmaceutical Formulations, Part 2: An Update on Analytical Techniques and Applications for Therapeutic Proteins, Viruses, Vaccines and Cells

Comparison of the Protective Effect of Polysorbates, Poloxamer and Brij on Antibody Stability Against Different Interfaces

Surface-Induced Protein Aggregation and Particle Formation in Biologics: Current Understanding of Mechanisms, Detection and Mitigation Strategies

Novel High-Throughput Assay for Polysorbate Quantification in Biopharmaceutical Products by Using the Fluorescent Dye DiI

Combining Machine Learning and Backgrounded Membrane Imaging: A Case Study in Comparing and Classifying Different Types of Biopharmaceutically Relevant Particles

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

Industry perspective on a holistic container closure integrity approach to parenteral combination products

Monitoring of Visible Particles in Parenteral Products by Manual Visual Inspection—Reassessing Size Threshold and Other Particle Characteristics that Define Particle Visibility

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 (2-100μm) Particle Analysis During Biotherapeutic Drug Product Development: Part 1, Considerations and Strategy

An Interlaboratory Study to Identify Potential Visible Protein-Like Particle Standards

A Multicompany Survey Study for Helium Leak Container Closure Integrity Test

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

A Biopharmaceutical Industry Perspective on the Control of Visible Particles in Biotechnology-Derived Injectable Drug Products

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