Machine learning and statistical analyses for extracting and characterizing “fingerprints” of antibody aggregation at container interfaces from flow microscopy images

Automatic Identification of the Stress Sources of Protein Aggregates Using Flow Imaging Microscopy Images

(2019) Arni Gambe-Gilbuena et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Shocking Data On Parcel Shipments of Protein Solutions

(2019) Christine Siska et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Deep Convolutional Neural Network Analysis of Flow Imaging Microscopy Data to Classify Subvisible Particles in Protein Formulations

(2018) Christopher P. Calderon et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

The Impact of Inadequate Temperature Storage Conditions on Aggregate and Particle Formation in Drugs Containing Tumor Necrosis Factor-Alpha Inhibitors

(2018) N. D. Vlieland et al.   PHARMACEUTICAL RESEARCH

Protein aggregation – Mechanisms, detection, and control

(2018) Wei Wang et al.   INTERNATIONAL JOURNAL OF PHARMACEUTICS

Protein aggregation under high concentration/density state during chromatographic and ultrafiltration processes

(2017) Tsutomu Arakawa et al.   INTERNATIONAL JOURNAL OF BIOLOGICAL MACROMOLECULES

Immunogenicity of Structurally Perturbed Hen Egg Lysozyme Adsorbed to Silicone Oil Microdroplets in Wild-Type and Transgenic Mouse Models

(2017) Carly F. Chisholm et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Stability of Proteins in Carbohydrates and Other Additives during Freezing: The Human Growth Hormone as a Case Study

(2017) Andrea Arsiccio et al.   JOURNAL OF PHYSICAL CHEMISTRY B

Dermatologist-level classification of skin cancer with deep neural networks

(2017) Andre Esteva et al.   NATURE

Mouse Models for Assessing Protein Immunogenicity: Lessons and Challenges

(2016) Wim Jiskoot et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Aggregation and Particle Formation of Therapeutic Proteins in Contact With a Novel Fluoropolymer Surface Versus Siliconized Surfaces: Effects of Agitation in Vials and in Prefilled Syringes

(2016) Brandon M. Teska et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Influence of particle shedding from silicone tubing on antibody stability

(2016) Verena Saller et al.   JOURNAL OF PHARMACY AND PHARMACOLOGY

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

Effects of Syringe Material and Silicone Oil Lubrication on the Stability of Pharmaceutical Proteins

(2015) Elena Krayukhina et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Protein aggregation and its impact on product quality

(2014) Christopher J Roberts   CURRENT OPINION IN BIOTECHNOLOGY

Investigations into the Fouling Mechanism of Parvovirus Filters During Filtration of Freeze–Thawed mAb Drug Substance Solutions

(2014) James G. Barnard et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Protein Aggregation and Particle Formation in Prefilled Glass Syringes

(2014) Alana Gerhardt et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Investigation of the Immunogenicity of Different Types of Aggregates of a Murine Monoclonal Antibody in Mice

(2014) Angelika J. Freitag et al.   PHARMACEUTICAL RESEARCH

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

(2013) Sarah Zölls et al.   AAPS Journal

In Situ Spectroscopic Quantification of Protein–Ice Interactions

(2013) Alan Twomey et al.   JOURNAL OF PHYSICAL CHEMISTRY B

Particles Shed from Syringe Filters and Their Effects on Agitation-Induced Protein Aggregation

(2012) Lu Liu et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Accelerated Stability Studies of Abatacept Formulations: Comparison of Freeze–Thawing- and Agitation-induced Stresses

(2012) Amanda A. Cordes et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Compatibility, Physical Stability, and Characterization of an IgG4 Monoclonal Antibody After Dilution into Different Intravenous Administration Bags

(2012) Ozan S. Kumru et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Classification and Characterization of Therapeutic Antibody Aggregates

(2011) Marisa K. Joubert et al.   JOURNAL OF BIOLOGICAL CHEMISTRY

Characterization of Subvisible Particle Formation During the Filling Pump Operation of a Monoclonal Antibody Solution

(2011) Arpan Nayak et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Effects of Surfaces and Leachables on the Stability of Biopharmaceuticals

(2011) Jared S. Bee et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

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

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

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

Subvisible Particle Counting Provides a Sensitive Method of Detecting and Quantifying Aggregation of Monoclonal Antibody Caused by Freeze-Thawing: Insights Into the Roles of Particles in the Protein Aggregation Pathway

(2010) James G. Barnard et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Impact of freezing on pH of buffered solutions and consequences for monoclonal antibody aggregation

(2009) Parag Kolhe et al.   BIOTECHNOLOGY PROGRESS

Immunogenicity of aggregates of recombinant human growth hormone in mouse models

(2009) Amber Haynes Fradkin et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Protein adsorption and excipient effects on kinetic stability of silicone oil emulsions

(2009) D.Brett Ludwig et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Freezing-Induced Phase Separation and Spatial Microheterogeneity in Protein Solutions

(2009) Jinping Dong et al.   JOURNAL OF PHYSICAL CHEMISTRY B

Shaken, Not Stirred: Mechanical Stress Testing of an IgG1 Antibody

(2008) Sylvia Kiese et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

IgG particle formation during filling pump operation: A case study of heterogeneous nucleation on stainless steel nanoparticles

(2008) Anil K. Tyagi et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Effects of Solution Conditions, Processing Parameters, and Container Materials on Aggregation of a Monoclonal Antibody during Freeze-Thawing

(2007) Lisa A. Kueltzo et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Polysorbates 20 and 80 Used in the Formulation of Protein Biotherapeutics: Structure and Degradation Pathways

(2007) Bruce A. Kerwin   JOURNAL OF PHARMACEUTICAL SCIENCES