Pharmacokinetics of monoclonal antibodies and Fc-fusion proteins

Determination of critical quality attributes for monoclonal antibodies using quality by design principles

(2016) Nadja Alt et al.   BIOLOGICALS

Sweeping antibody as a novel therapeutic antibody modality capable of eliminating soluble antigens from circulation

(2016) Tomoyuki Igawa et al.   IMMUNOLOGICAL REVIEWS

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

(2016) Amita Datta-Mannan et al.   mAbs

The Interplay of Antigen Affinity, Internalization, and Pharmacokinetics on CD44-Positive Tumor Targeting of Monoclonal Antibodies

(2016) Dylan M. Glatt et al.   MOLECULAR PHARMACEUTICS

FG-3019, a Human Monoclonal Antibody Recognizing Connective Tissue Growth Factor, is Subject to Target-Mediated Drug Disposition

(2016) Mitchell C. Brenner et al.   PHARMACEUTICAL RESEARCH

An FDA oncology analysis of immune activating products and first-in-human dose selection

(2016) Haleh Saber et al.   REGULATORY TOXICOLOGY AND PHARMACOLOGY

Projecting human pharmacokinetics of monoclonal antibodies from nonclinical data: comparative evaluation of prediction approaches in early drug development

(2015) Jing Wang et al.   BIOPHARMACEUTICS & DRUG DISPOSITION

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

IgG1 Allotypes Influence the Pharmacokinetics of Therapeutic Monoclonal Antibodies through FcRn Binding

(2015) David Ternant et al.   JOURNAL OF IMMUNOLOGY

Antibody Glycosylation and Its Impact on the Pharmacokinetics and Pharmacodynamics of Monoclonal Antibodies and Fc-Fusion Proteins

(2015) Liming Liu   JOURNAL OF PHARMACEUTICAL SCIENCES

Effect of Individual Fc Methionine Oxidation on FcRn Binding: Met252 Oxidation Impairs FcRn Binding More Profoundly than Met428 Oxidation

(2015) Xuan Gao et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

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

(2015) Ryan L Kelly et al.   mAbs

Comprehensive Characterization of Relationship Between Higher-Order Structure and FcRn Binding Affinity of Stress-Exposed Monoclonal Antibodies

(2015) Daisuke Tsuchida et al.   PHARMACEUTICAL RESEARCH

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

The application of allometric scaling principles to predict pharmacokinetic parameters across species

(2014) Qingbiao Huang et al.   Expert Opinion on Drug Metabolism & Toxicology

Subcutaneous Administration of Monoclonal Antibodies in Oncology

(2014) C. Jackisch et al.   GEBURTSHILFE UND FRAUENHEILKUNDE

Modulation of Mannose and Asialoglycoprotein Receptor Expression Determines Glycoprotein Hormone Half-life at Critical Points in the Reproductive Cycle

(2014) Yiling Mi et al.   JOURNAL OF BIOLOGICAL CHEMISTRY

Comparison of Subcutaneous Versus Intravenous Administration of Rituximab As Maintenance Treatment for Follicular Lymphoma: Results From a Two-Stage, Phase IB Study

(2014) Antonio Salar et al.   JOURNAL OF CLINICAL ONCOLOGY

Use of Fc-Engineered Antibodies as Clearing Agents to Increase Contrast During PET

(2014) R. Swiercz et al.   JOURNAL OF NUCLEAR MEDICINE

The therapeutic monoclonal antibody market

(2014) Dawn M Ecker et al.   mAbs

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

(2014) Bing Li et al.   mAbs

Modeling, Simulation, and Translation Framework for the Preclinical Development of Monoclonal Antibodies

(2013) Kenneth T. Luu et al.   AAPS Journal

Theoretical Considerations and Practical Approaches to Address the Effect of Anti-drug Antibody (ADA) on Quantification of Biotherapeutics in Circulation

(2013) Marian Kelley et al.   AAPS Journal

A Novel Investigational Fc-Modified Humanized Monoclonal Antibody, Motavizumab-YTE, Has an Extended Half-Life in Healthy Adults

(2013) Gabriel J. Robbie et al.   ANTIMICROBIAL AGENTS AND CHEMOTHERAPY

Subcutaneous administration of rituximab (MabThera) and trastuzumab (Herceptin) using hyaluronidase

(2013) O Shpilberg et al.   BRITISH JOURNAL OF CANCER

Application of knockout mouse models to investigate the influence of FcγR on the pharmacokinetics and anti-platelet effects of MWReg30, a monoclonal anti-GPIIb antibody

(2013) Lubna Abuqayyas et al.   INTERNATIONAL JOURNAL OF PHARMACEUTICS

Immunogenicity of mAbs in non-human primates during nonclinical safety assessment

(2013) Peter J.K. van Meer et al.   mAbs

Autoantibody depletion ameliorates disease in murine experimental autoimmune encephalomyelitis

(2013) Dilip K. Challa et al.   mAbs

Antibody biodistribution coefficients

(2013) Dhaval K. Shah et al.   mAbs

Identification and Multidimensional Optimization of an Asymmetric Bispecific IgG Antibody Mimicking the Function of Factor VIII Cofactor Activity

(2013) Zenjiro Sampei et al.   PLoS One

Engineered Monoclonal Antibody with Novel Antigen-Sweeping Activity In Vivo

(2013) Tomoyuki Igawa et al.   PLoS One

Subcutaneous versus Intravenous Administration of Rituximab: Pharmacokinetics, CD20 Target Coverage and B-Cell Depletion in Cynomolgus Monkeys

(2013) Cheng-Ping Mao et al.   PLoS One

Immunogenicity to Therapeutic Proteins: Impact on PK/PD and Efficacy

(2012) Narendra Chirmule et al.   AAPS Journal

Mechanistic Determinants of Biotherapeutics Absorption Following SC Administration

(2012) Wolfgang F. Richter et al.   AAPS Journal

Physiochemical and Biochemical Factors Influencing the Pharmacokinetics of Antibody Therapeutics

(2012) Daniela Bumbaca et al.   AAPS Journal

Development of a Subcutaneous Formulation for Trastuzumab - Nonclinical and Clinical Bridging Approach to the Approved Intravenous Dosing Regimen

(2012) B. Bittner et al.   ARZNEIMITTEL-FORSCHUNG-DRUG RESEARCH

A Guide to Rational Dosing of Monoclonal Antibodies

(2012) Shuang Bai et al.   CLINICAL PHARMACOKINETICS

Comparison of Subcutaneous and Intravenous Administration of Trastuzumab: A Phase I/Ib Trial in Healthy Male Volunteers and Patients With HER2-Positive Breast Cancer

(2012) Chris Wynne et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Minipig as a potential translatable model for monoclonal antibody pharmacokinetics after intravenous and subcutaneous administration

(2012) Yanan Zheng et al.   mAbs

A strategy for risk mitigation of antibodies with fast clearance

(2012) Isidro Hötzel et al.   mAbs

Influence of improved FcRn binding on the subcutaneous bioavailability of monoclonal antibodies in cynomolgus monkeys

(2012) Amita Datta-Mannan et al.   mAbs

Production, characterization and pharmacokinetic properties of antibodies with N-linked Mannose-5 glycans

(2012) Marcella Yu et al.   mAbs

The Impact of Glycosylation on the Pharmacokinetics of a TNFR2:Fc Fusion Protein Expressed in Glycoengineered Pichia Pastoris

(2012) Liming Liu et al.   PHARMACEUTICAL RESEARCH

Pharmacokinetics of IgG1 monoclonal antibodies produced in humanized Pichia pastoris with specific glycoforms: A comparative study with CHO produced materials

(2011) Liming Liu et al.   BIOLOGICALS

Influence of Affinity and Antigen Internalization on the Uptake and Penetration of Anti-HER2 Antibodies in Solid Tumors

(2011) S. I. Rudnick et al.   CANCER RESEARCH

Quantitative Prediction of Human Pharmacokinetics for Monoclonal Antibodies

(2011) Jennifer Q. Dong et al.   CLINICAL PHARMACOKINETICS

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

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

Prediction of Human Pharmacokinetics of Therapeutic Monoclonal Antibodies from Simple Allometry of Monkey Data

(2011) Masataka Oitate et al.   Drug Metabolism and Pharmacokinetics

High-mannose glycans on the Fc region of therapeutic IgG antibodies increase serum clearance in humans

(2011) A. M. Goetze et al.   GLYCOBIOLOGY

Serum albumin concentration: a predictive factor of infliximab pharmacokinetics and clinical response in patients with ulcerative colitis

(2011) A.A. Fasanmade et al.   INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS

Therapeutic antibodies: Market considerations, disease targets and bioprocessing

(2011) John G. Elvin et al.   INTERNATIONAL JOURNAL OF PHARMACEUTICS

Development of Antidrug Antibodies Against Adalimumab and Association With Disease Activity and Treatment Failure During Long-term Follow-up

(2011) Geertje M. Bartelds   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Neonatal Fc Receptor Blockade by Fc Engineering Ameliorates Arthritis in a Murine Model

(2011) D. A. Patel et al.   JOURNAL OF IMMUNOLOGY

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

(2011) Daniela Bumbaca et al.   mAbs

Projecting human pharmacokinetics of therapeutic antibodies from nonclinical data

(2011) Rong Deng et al.   mAbs

Impact of methionine oxidation in human IgG1 Fc on serum half-life of monoclonal antibodies

(2011) Weirong Wang et al.   MOLECULAR IMMUNOLOGY

Complex Pharmacokinetics of a Humanized Antibody Against Human Amyloid Beta Peptide, Anti-Abeta Ab2, in Nonclinical Species

(2011) Yulia Vugmeyster et al.   PHARMACEUTICAL RESEARCH

Effects of Charge on Antibody Tissue Distribution and Pharmacokinetics

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

Efficient Tumor Targeting with High-Affinity Designed Ankyrin Repeat Proteins: Effects of Affinity and Molecular Size

(2010) C. Zahnd et al.   CANCER RESEARCH

A Therapeutic Anti-VEGF Antibody with Increased Potency Independent of Pharmacokinetic Half-life

(2010) Y. A. Yeung et al.   CANCER RESEARCH

Population Pharmacokinetics of Therapeutic Monoclonal Antibodies

(2010) Nathanael L. Dirks et al.   CLINICAL PHARMACOKINETICS

Pharmacokinetics of Humanized Monoclonal Anti-Tumor Necrosis Factor-  Antibody and Its Neonatal Fc Receptor Variants in Mice and Cynomolgus Monkeys

(2010) R. Deng et al.   DRUG METABOLISM AND DISPOSITION

A Novel Strategy To Reduce the Immunogenicity of Biological Therapies

(2010) J. Somerfield et al.   JOURNAL OF IMMUNOLOGY

Charge variants in IgG1

(2010) Leslie A. Khawli et al.   mAbs

The immunogenicity of humanized and fully human antibodies

(2010) Fiona A. Harding et al.   mAbs

Antibody recycling by engineered pH-dependent antigen binding improves the duration of antigen neutralization

(2010) Tomoyuki Igawa et al.   NATURE BIOTECHNOLOGY

Reduced elimination of IgG antibodies by engineering the variable region

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

The minimum anticipated biological effect level (MABEL) for selection of first human dose in clinical trials with monoclonal antibodies

(2009) Patrick Y Muller et al.   CURRENT OPINION IN BIOTECHNOLOGY

Fixed Dosing Versus Body Size-Based Dosing of Monoclonal Antibodies in Adult Clinical Trials

(2009) Diane D. Wang et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Interspecies Scaling of Therapeutic Monoclonal Antibodies: Initial Look

(2009) Jie Ling et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Engineering Human IgG1 Affinity to Human Neonatal Fc Receptor: Impact of Affinity Improvement on Pharmacokinetics in Primates

(2009) Y. A. Yeung et al.   JOURNAL OF IMMUNOLOGY

Gaining insights into the consequences of target-mediated drug disposition of monoclonal antibodies using quasi-steady-state approximations

(2009) Hans Peter Grimm   JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS

Impact of methionine oxidation on the binding of human IgG1 to FcRn and Fcγ receptors

(2009) Andrea Bertolotti-Ciarlet et al.   MOLECULAR IMMUNOLOGY

Glycosylation as a strategy to improve antibody-based therapeutics

(2009) Roy Jefferis   NATURE REVIEWS DRUG DISCOVERY

Methionine oxidation in human IgG2 Fc decreases binding affinities to protein A and FcRn

(2009) Hai Pan et al.   PROTEIN SCIENCE

Recombinant antibody therapeutics: the impact of glycosylation on mechanisms of action

(2009) Royston Jefferis   TRENDS IN PHARMACOLOGICAL SCIENCES

Off-target activity of TNF-α inhibitors characterized by protein biochips

(2008) Oliver Feyen et al.   ANALYTICAL AND BIOANALYTICAL CHEMISTRY

Determination and validation of off-target activities of anti-CD44 variant 6 antibodies using protein biochips and tissue microarrays

(2008) Angelika Lueking et al.   BIOTECHNIQUES

Monoclonal Antibody Pharmacokinetics and Pharmacodynamics

(2008) W Wang et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

The effect of Fc glycan forms on human IgG2 antibody clearance in humans

(2008) X. Chen et al.   GLYCOBIOLOGY

Rapid characterization of binding specificity and cross-reactivity of antibodies using recombinant human protein arrays

(2008) Gregor Kijanka et al.   JOURNAL OF IMMUNOLOGICAL METHODS

Approximations of the target-mediated drug disposition model and identifiability of model parameters

(2008) Leonid Gibiansky et al.   JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS

Evidence for an Asialoglycoprotein Receptor on Nonparenchymal Cells for O-Linked Glycoproteins

(2008) E. G. Stefanich et al.   JOURNAL OF PHARMACOLOGY AND EXPERIMENTAL THERAPEUTICS

Characterization of a complex glycoprotein whose variable metabolic clearance in humans is dependent on terminal N-acetylglucosamine content

(2007) Rodney Keck et al.   BIOLOGICALS