Utility of physiologically based pharmacokinetic modeling to predict inter-antibody variability in monoclonal antibody pharmacokinetics in mice

FDA Modernization Act 2.0 allows for alternatives to animal testing

(2023) Jason J. Han   ARTIFICIAL ORGANS

Development of in silico models to predict viscosity and mouse clearance using a comprehensive analytical data set collected on 83 scaffold-consistent monoclonal antibodies

(2023) Marissa Mock et al.   mAbs

Physiologically Based Modeling to Predict Monoclonal Antibody Pharmacokinetics in Humans from in vitro Physiochemical Properties

(2022) Shihao Hu et al.   mAbs

FDA approves 100th monoclonal antibody product

(2021) Asher Mullard   NATURE REVIEWS DRUG DISCOVERY

Predicting monoclonal antibody pharmacokinetics following subcutaneous administration via whole-body physiologically-based modeling

(2020) Shihao Hu et al.   JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS

The biodistribution of therapeutic proteins: Mechanism, implications for pharmacokinetics, and methods of evaluation

(2020) Kip P. Conner et al.   PHARMACOLOGY & THERAPEUTICS

Five computational developability guidelines for therapeutic antibody profiling

(2019) Matthew I. J. Raybould et al.   PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA

An in vitro FcRn- dependent transcytosis assay as a screening tool for predictive assessment of nonspecific clearance of antibody therapeutics in humans

(2019) Shan Chung et al.   mAbs

Heparin chromatography as an in vitro predictor for antibody clearance rate through pinocytosis

(2019) Thomas E. Kraft et al.   mAbs

Selecting and engineering monoclonal antibodies with drug-like specificity

(2019) Charles G Starr et al.   CURRENT OPINION IN BIOTECHNOLOGY

Establishing in vitro in vivo correlations to screen monoclonal antibodies for physicochemical properties related to favorable human pharmacokinetics

(2018) Lindsay B. Avery et al.   mAbs

Linear pharmacokinetic parameters for monoclonal antibodies are similar within a species and across different pharmacological targets: A comparison between human, cynomolgus monkey and hFcRn Tg32 transgenic mouse using a population-modeling approach

(2018) Alison Betts et al.   mAbs

Towards a combinatorial approach for the prediction of immunoglobulin G half-life and clearance

(2018) Dennis R. Goulet et al.   DRUG METABOLISM AND DISPOSITION

Pharmacokinetic de-risking tools for selection of monoclonal antibody lead candidates

(2017) Miroslav Dostalek et al.   mAbs

Biophysical properties of the clinical-stage antibody landscape

(2017) Tushar Jain et al.   PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA

Evaluation of an FcRn affinity chromatographic method for IgG1-type antibodies and evaluation of IgG variants

(2017) Florian Cymer et al.   Bioanalysis

Biological Characterization of a Stable Effector Functionless (SEFL) Monoclonal Antibody Scaffoldin Vitro

(2016) Ling Liu et al.   JOURNAL OF BIOLOGICAL CHEMISTRY

Utility of a human FcRn transgenic mouse model in drug discovery for early assessment and prediction of human pharmacokinetics of monoclonal antibodies

(2016) Lindsay B. Avery et al.   mAbs

Target-independent variable region mediated effects on antibody clearance can be FcRn independent

(2016) Ryan L. Kelly et al.   mAbs

Aberrant bispecific antibody pharmacokinetics linked to liver sinusoidal endothelium clearance mechanism in cynomolgus monkeys

(2016) Amita Datta-Mannan et al.   mAbs

Evaluating the Use of Antibody Variable Region (Fv) Charge as a Risk Assessment Tool for Predicting Typical Cynomolgus Monkey Pharmacokinetics

(2015) Daniela Bumbaca Yadav et al.   JOURNAL OF BIOLOGICAL CHEMISTRY

Development and applications of AlphaScreen-based FcRn binding assay to characterize monoclonal antibodies

(2015) Qiang Wu et al.   JOURNAL OF IMMUNOLOGICAL METHODS

High throughput cross-interaction measures for human IgG1 antibodies correlate with clearance rates in mice

(2015) Ryan L Kelly et al.   mAbs

The interplay of non-specific binding, target-mediated clearance and FcRn interactions on the pharmacokinetics of humanized antibodies

(2015) Amita Datta-Mannan et al.   mAbs

Balancing charge in the complementarity-determining regions of humanized mAbs without affecting pI reduces non-specific binding and improves the pharmacokinetics

(2015) Amita Datta-Mannan et al.   mAbs

A novel in vitro assay to predict neonatal Fc receptor-mediated human IgG half-life

(2015) Colby A Souders et al.   mAbs

Charge-mediated influence of the antibody variable domain on FcRn-dependent pharmacokinetics

(2015) Angela Schoch et al.   PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA

Framework selection can influence pharmacokinetics of a humanized therapeutic antibody through differences in molecule charge

(2014) Bing Li et al.   mAbs

In silico selection of therapeutic antibodies for development: Viscosity, clearance, and chemical stability

(2014) Vikas K. Sharma et al.   PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA

Analytical FcRn affinity chromatography for functional characterization of monoclonal antibodies

(2013) Tilman Schlothauer et al.   mAbs

High-throughput screening for developability during early-stage antibody discovery using self-interaction nanoparticle spectroscopy

(2013) Yuqi Liu et al.   mAbs

Addressing polyspecificity of antibodies selected from an in vitro yeast presentation system: a FACS-based, high-throughput selection and analytical tool

(2013) Y. Xu et al.   PROTEIN ENGINEERING DESIGN & SELECTION

A strategy for risk mitigation of antibodies with fast clearance

(2012) Isidro Hötzel et al.   mAbs

Targeted Delivery of PLK1-siRNA by ScFv Suppresses Her2+ Breast Cancer Growth and Metastasis

(2012) Y.-d. Yao et al.   Science Translational Medicine

Monoclonal Antibodies with Identical Fc Sequences Can Bind to FcRn Differentially with Pharmacokinetic Consequences

(2011) W. Wang et al.   DRUG METABOLISM AND DISPOSITION

Towards a platform PBPK model to characterize the plasma and tissue disposition of monoclonal antibodies in preclinical species and human

(2011) Dhaval K. Shah et al.   JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS

Highly specific off-target binding identified and eliminated during the humanization of an antibody against FGF receptor 4

(2011) Daniela Bumbaca et al.   mAbs

Effects of Charge on Antibody Tissue Distribution and Pharmacokinetics

(2010) C. Andrew Boswell et al.   BIOCONJUGATE CHEMISTRY

A critical evaluation of self-interaction chromatography as a predictive tool for the assessment of protein–protein interactions in protein formulation development: A case study of a therapeutic monoclonal antibody

(2010) Virginie Le Brun et al.   EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

Reduced elimination of IgG antibodies by engineering the variable region

(2010) T. Igawa et al.   PROTEIN ENGINEERING DESIGN & SELECTION

Biospecific protein immobilization for rapid analysis of weak protein interactions using self-interaction nanoparticle spectroscopy

(2009) Aditya N. Bengali et al.   BIOTECHNOLOGY AND BIOENGINEERING

Cross-Interaction Chromatography: A Rapid Method to Identify Highly Soluble Monoclonal Antibody Candidates

(2009) Steven A. Jacobs et al.   PHARMACEUTICAL RESEARCH

High-Throughput Self-Interaction Chromatography: Applications in Protein Formulation Prediction

(2008) David H. Johnson et al.   PHARMACEUTICAL RESEARCH