Long-term stability predictions of therapeutic monoclonal antibodies in solution using Arrhenius-based kinetics

Mol* Viewer: modern web app for 3D visualization and analysis of large biomolecular structures

(2021) David Sehnal et al.   NUCLEIC ACIDS RESEARCH

Application of machine learning to predict monomer retention of therapeutic proteins after long term storage

(2020) Lorenzo Gentiluomo et al.   INTERNATIONAL JOURNAL OF PHARMACEUTICS

Surfaces Affect Screening Reliability in Formulation Development of Biologics

(2020) Mitja Zidar et al.   PHARMACEUTICAL RESEARCH

Monte Carlo Simulations for the Analysis of Non-linear Parameter Confidence Intervals in Optimal Experimental Design

(2019) Niels Krausch et al.   Frontiers in Bioengineering and Biotechnology

Accelerated Aggregation Studies of Monoclonal Antibodies: Considerations for Storage Stability

(2019) Ruben Wälchli et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Chemical and physical instabilities in manufacturing and storage of therapeutic proteins

(2019) Mary E Krause et al.   CURRENT OPINION IN BIOTECHNOLOGY

Accurate prediction of vaccine stability under real storage conditions and during temperature excursions

(2018) Didier Clénet   EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

Notorious but not understood: How liquid-air interfacial stress triggers protein aggregation

(2018) Ellen Koepf et al.   INTERNATIONAL JOURNAL OF PHARMACEUTICS

Characterisation of protein aggregation with the Smoluchowski coagulation approach for use in biopharmaceuticals

(2018) Mitja Zidar et al.   Soft Matter

Expectations for Phase-Appropriate Drug Substance and Drug Product Specifications for Early-Stage Protein Therapeutics

(2018) Juliana Kretsinger et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Charge variants characterization of a monoclonal antibody by ion exchange chromatography coupled on-line to native mass spectrometry: Case study after a long-term storage at +5 °C

(2017) Y. Leblanc et al.   JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES

Forced degradation of recombinant monoclonal antibodies: A practical guide

(2017) Christine Nowak et al.   mAbs

Understanding the Impact of Methionine Oxidation on the Biological Functions of IgG1 Antibodies Using Hydrogen/Deuterium Exchange Mass Spectrometry

(2016) Jingjie Mo et al.   ANALYTICAL CHEMISTRY

Kinetics of Monoclonal Antibody Aggregation from Dilute toward Concentrated Conditions

(2016) Lucrèce Nicoud et al.   JOURNAL OF PHYSICAL CHEMISTRY B

Denatured state aggregation parameters derived from concentration dependence of protein stability

(2015) Arne Schön et al.   ANALYTICAL BIOCHEMISTRY

Protein aggregation, particle formation, characterization & rheology

(2014) Samiul Amin et al.   CURRENT OPINION IN COLLOID & INTERFACE SCIENCE

A Scientific and Statistical Analysis of Accelerated Aging for Pharmaceuticals. Part 1: Accuracy of Fitting Methods

(2014) Kenneth C. Waterman et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Kinetic Analysis of the Multistep Aggregation Mechanism of Monoclonal Antibodies

(2014) Lucrèce Nicoud et al.   JOURNAL OF PHYSICAL CHEMISTRY B

Non-Arrhenius Protein Aggregation

(2013) Wei Wang et al.   AAPS Journal

Monitoring protein aggregation kinetics with simultaneous multiple sample light scattering

(2013) Michael F. Drenski et al.   ANALYTICAL BIOCHEMISTRY

Chemical denaturation as a tool in the formulation optimization of biologics

(2013) Ernesto Freire et al.   DRUG DISCOVERY TODAY

A Mechanistic Model for Amorphous Protein Aggregation of Immunoglobulin-like Domains

(2013) Madeleine B. Borgia et al.   JOURNAL OF THE AMERICAN CHEMICAL SOCIETY

Population Balance Modeling of Antibodies Aggregation Kinetics

(2012) Paolo Arosio et al.   JOURNAL OF PHYSICAL CHEMISTRY B

The Application of the Accelerated Stability Assessment Program (ASAP) to Quality by Design (QbD) for Drug Product Stability

(2011) Kenneth Craig Waterman   AAPS PHARMSCITECH

Monte Carlo simulation of parameter confidence intervals for non-linear regression analysis of biological data using Microsoft Excel

(2011) Ronald J.W. Lambert et al.   COMPUTER METHODS AND PROGRAMS IN BIOMEDICINE

Reporter gene assay for the quantification of the activity and neutralizing antibody response to TNFα antagonists

(2011) Christophe Lallemand et al.   JOURNAL OF IMMUNOLOGICAL METHODS

Evaluation of a Non-Arrhenius Model for Therapeutic Monoclonal Antibody Aggregation

(2011) Veysel Kayser et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Predicting accelerated aggregation rates for monoclonal antibody formulations, and challenges for low-temperature predictions

(2011) Rebecca K. Brummitt et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Characterization of Recombinant Human IL-15 Deamidation and Its Practical Elimination through Substitution of Asparagine 77

(2011) David F. Nellis et al.   PHARMACEUTICAL RESEARCH

Solution of the Structure of the TNF-TNFR2 Complex

(2010) Y. Mukai et al.   Science Signaling

Basic principles of stability

(2009) William Egan et al.   BIOLOGICALS

BOOTSTRAP CONFIDENCE INTERVALS FOR THE KINETIC PARAMETERS OF DEGRADATION OF ANTHOCYANINS IN GRAPE POMACE

(2009) D.K. MISHRA et al.   JOURNAL OF FOOD PROCESS ENGINEERING

Principles, approaches, and challenges for predicting protein aggregation rates and shelf life

(2008) William F. Weiss et al.   JOURNAL OF PHARMACEUTICAL SCIENCES