Micro-Flow Imaging multi-instrument evaluation for sub-visible particle detection

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

(2022) Christopher P. Calderon et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Qualitative High-Throughput Analysis of Subvisible Particles in Biological Formulations Using Backgrounded Membrane Imaging

(2022) Markela Ibo Murphy et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Particle Detection and Characterization for Biopharmaceutical Applications: Current Principles of Established and Alternative Techniques

(2020) Julia Gross-Rother et al.   Pharmaceutics

Backgrounded membrane imaging (BMI) for high-throughput characterization of subvisible particles during biopharmaceutical drug product development

(2019) C. Helbig et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Variance between different Light Obscuration and Flow Imaging Microscopy Instruments and the Impact of Instrument Calibration

(2019) Anja Matter et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Interactions between polystyrene particles with diameters of several tens to hundreds of micrometers at the oil–water interface

(2019) Lee Ha Eun et al.   JOURNAL OF COLLOID AND INTERFACE SCIENCE

Collaborative Study For Analysis Of Subvisible Particles Using Flow Imaging And Light Obscuration: Experiences In Japanese Biopharmaceutical Consortium

(2018) Masato Kiyoshi et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

High-concentration protein formulations: How high is high?

(2017) Patrick Garidel et al.   EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

Microflow Imaging Analyses Reflect Mechanisms of Aggregate Formation: Comparing Protein Particle Data Sets Using the Kullback–Leibler Divergence

(2017) Nathaniel R. Maddux et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Closing the Gap: Counting and Sizing of Particles Across Submicron Range by Flow Cytometry in Therapeutic Protein Products

(2017) Liling Zhang et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Characterization of Protein Particles in Therapeutic Formulations Using Imaging Flow Cytometry

(2017) Christine Probst et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Nanoparticle tracking analysis of particle size and concentration detection in suspensions of polymer and protein samples: Influence of experimental and data evaluation parameters

(2016) Julia Gross et al.   EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

Synthesis, structure information, DNA/BSA binding affinity and in vitro cytotoxic studies of mixed ligand copper(II) complexes containing a phenylalanine derivative and diimine co-ligands

(2016) B. Annaraj et al.   JOURNAL OF PHOTOCHEMISTRY AND PHOTOBIOLOGY B-BIOLOGY

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

(2015) Vincent Corvari et al.   BIOLOGICALS

An Interlaboratory Comparison of Sizing and Counting of Subvisible Particles Mimicking Protein Aggregates

(2015) Dean C. Ripple et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

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

(2015) Linda O. Narhi et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Sterile Filtration of Highly Concentrated Protein Formulations: Impact of Protein Concentration, Formulation Composition, and Filter Material

(2015) Andrea Allmendinger et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Factors Governing the Precision of Subvisible Particle Measurement Methods – A Case Study with a Low-Concentration Therapeutic Protein Product in a Prefilled Syringe

(2015) Anacelia Ríos Quiroz et al.   PHARMACEUTICAL RESEARCH

Overcoming the challenges in administering biopharmaceuticals: formulation and delivery strategies

(2014) Samir Mitragotri et al.   NATURE REVIEWS DRUG DISCOVERY

Flow Imaging Microscopy for Protein Particle Analysis—A Comparative Evaluation of Four Different Analytical Instruments

(2013) Sarah Zölls et al.   AAPS Journal

How Subvisible Particles Become Invisible—Relevance of the Refractive Index for Protein Particle Analysis

(2013) Sarah Zölls et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Micro–Flow Imaging and Resonant Mass Measurement (Archimedes) – Complementary Methods to Quantitatively Differentiate Protein Particles and Silicone Oil Droplets

(2013) Daniel Weinbuch et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Protein Particulate Detection Issues in Biotherapeutics Development—Current Status

(2012) Tapan K. Das   AAPS PHARMSCITECH

Classification of Protein Aggregates1

(2011) Linda O. Narhi et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Particles in Therapeutic Protein Formulations, Part 1: Overview of Analytical Methods

(2011) Sarah Zölls et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Discrimination Between Silicone Oil Droplets and Protein Aggregates in Biopharmaceuticals: A Novel Multiparametric Image Filter for Sub-visible Particles in Microflow Imaging Analysis

(2011) René Strehl et al.   PHARMACEUTICAL RESEARCH

Micro-Flow Imaging: Flow Microscopy Applied to Sub-visible Particulate Analysis in Protein Formulations

(2010) Deepak K. Sharma et al.   AAPS Journal

Characterization of Particles in Protein Solutions: Reaching the Limits of Current Technologies

(2010) Barthélemy Demeule et al.   AAPS Journal

Protein aggregation—Pathways and influencing factors

(2010) Wei Wang et al.   INTERNATIONAL JOURNAL OF PHARMACEUTICS

Quantification and Characterization of Subvisible Proteinaceous Particles in Opalescent mAb Formulations Using Micro-Flow Imaging

(2010) Deepak K. Sharma et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

An Industry Perspective on the Monitoring of Subvisible Particles as a Quality Attribute for Protein Therapeutics

(2010) Satish K. Singh et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Critical Evaluation of Nanoparticle Tracking Analysis (NTA) by NanoSight for the Measurement of Nanoparticles and Protein Aggregates

(2010) Vasco Filipe et al.   PHARMACEUTICAL RESEARCH

Strategies for the Assessment of Protein Aggregates in Pharmaceutical Biotech Product Development

(2010) John den Engelsman et al.   PHARMACEUTICAL RESEARCH

Heterogeneity of the electrostatic repulsion between colloids at the oil–water interface

(2010) Bum Jun Park et al.   Soft Matter

Mechanisms of Protein Aggregation

(2009) John Philo et al.   CURRENT PHARMACEUTICAL BIOTECHNOLOGY

A Critical Review of Analytical Methods for Subvisible and Visible Particles

(2009) Linda Narhi et al.   CURRENT PHARMACEUTICAL BIOTECHNOLOGY

Quantitation of protein particles in parenteral solutions using micro-flow imaging

(2008) Chi-Ting Huang et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Protein aggregation: Pathways, induction factors and analysis

(2008) Hanns-Christian Mahler et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Interactions between a Polystyrene Particle and Hydrophilic and Hydrophobic Surfaces in Aqueous Solutions

(2008) Esben Thormann et al.   LANGMUIR

Protein therapeutics: a summary and pharmacological classification

(2007) Benjamin Leader et al.   NATURE REVIEWS DRUG DISCOVERY