Key factors influencing ADME properties of therapeutic proteins: A need for ADME characterization in drug discovery and development

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

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

Pharmacokinetics, metabolism and distribution of PEGs and PEGylated proteins: quo vadis?

(2014) Andreas Baumann et al.   DRUG DISCOVERY TODAY

Assessment of the metabolism of therapeutic proteins and antibodies

(2014) Eric Ezan et al.   Expert Opinion on Drug Metabolism & Toxicology

Improving the outcomes of biopharmaceutical delivery via the subcutaneous route by understanding the chemical, physical and physiological properties of the subcutaneous injection site

(2014) Hanne M. Kinnunen et al.   JOURNAL OF CONTROLLED RELEASE

Monoclonal antibody disposition: a simplified PBPK model and its implications for the derivation and interpretation of classical compartment models

(2014) Ludivine Fronton et al.   JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS

The effect of the neonatal Fc receptor on human IgG biodistribution in mice

(2014) Nancy Chen et al.   mAbs

Antibodies to watch in 2015

(2014) Janice M Reichert   mAbs

Quantitative cumulative biodistribution of antibodies in mice

(2014) Victor Yip et al.   mAbs

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

Whole-body and microscopic autoradiography to determine tissue distribution of biopharmaceuticals — Target discoveries with receptor micro-autoradiography engendered new concepts and therapies for vitamin D

(2013) Walter E. Stumpf   ADVANCED DRUG DELIVERY REVIEWS

Matching chelators to radiometals for radiopharmaceuticals

(2013) Eric W. Price et al.   CHEMICAL SOCIETY REVIEWS

Pharmacokinetics of Peptide–Fc Fusion Proteins

(2013) W.U. Benjamin et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

On translation of antibody drug conjugates efficacy from mouse experimental tumors to the clinic: a PK/PD approach

(2013) Nahor Haddish-Berhane et al.   JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS

Engineering synthetic vaccines using cues from natural immunity

(2013) Darrell J. Irvine et al.   NATURE MATERIALS

Efficient generation of stable bispecific IgG1 by controlled Fab-arm exchange

(2013) A. F. Labrijn et al.   PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA

ADME of monoclonal antibody biotherapeutics: knowledge gaps and emerging tools

(2013) Jean W Lee   Bioanalysis

Bioanalytical assay strategies for the development of antibody–drug conjugate biotherapeutics

(2013) Surinder Kaur et al.   Bioanalysis

ADME of Biologics—What Have We Learned from Small Molecules?

(2012) Thomayant Prueksaritanont et al.   AAPS Journal

Tissue Distribution Studies of Protein Therapeutics Using Molecular Probes: Molecular Imaging

(2012) Simon-Peter Williams   AAPS Journal

ADME of Antibody–Maytansinoid Conjugates

(2012) Hans K. Erickson et al.   AAPS Journal

Challenges and Opportunities in Absorption, Distribution, Metabolism, and Excretion Studies of Therapeutic Biologics

(2012) Xin Xu 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

Delivery of molecular and cellular medicine to solid tumors

(2012) Rakesh K. Jain   ADVANCED DRUG DELIVERY REVIEWS

Enzyme Replacement Therapy for Lysosomal Diseases: Lessons from 20 Years of Experience and Remaining Challenges

(2012) R.J. Desnick et al.   Annual Review of Genomics and Human Genetics

Radiolabeled Absorption, Distribution, Metabolism, and Excretion Studies in Drug Development: Why, When, and How?

(2012) Natalia Penner et al.   CHEMICAL RESEARCH IN TOXICOLOGY

Catabolic Fate and Pharmacokinetic Characterization of Trastuzumab Emtansine (T-DM1): an Emphasis on Preclinical and Clinical Catabolism

(2012) Ben-Quan Shen et al.   CURRENT DRUG METABOLISM

Preclinicalin vivoADME studies in drug development: a critical review

(2012) Mario Pellegatti   Expert Opinion on Drug Metabolism & Toxicology

The impact of glycosylation on monoclonal antibody conformation and stability

(2012) Kai Zheng et al.   mAbs

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

(2012) Yanan Zheng et al.   mAbs

Subcutaneous bioavailability of therapeutic antibodies as a function 
of FcRn binding affinity in mice

(2012) Rong Deng 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

Marketed therapeutic antibodies compendium

(2012) Janice M. Reichert   mAbs

Effects of Anti-VEGF on Pharmacokinetics, Biodistribution, and Tumor Penetration of Trastuzumab in a Preclinical Breast Cancer Model

(2012) C. V. Pastuskovas et al.   MOLECULAR CANCER THERAPEUTICS

Outlook for the next 5 years in drug innovation

(2012) Roy Berggren et al.   NATURE REVIEWS DRUG DISCOVERY

Impact of Drug Conjugation on Pharmacokinetics and Tissue Distribution of Anti-STEAP1 Antibody–Drug Conjugates in Rats

(2011) C. Andrew Boswell et al.   BIOCONJUGATE CHEMISTRY

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

Strategies for extended serum half-life of protein therapeutics

(2011) Roland E Kontermann   CURRENT OPINION IN BIOTECHNOLOGY

Can the flow of medicines be improved? Fundamental pharmacokinetic and pharmacological principles toward improving Phase II survival

(2011) Paul Morgan et al.   DRUG DISCOVERY TODAY

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

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

Mechanistic Modeling of Antigen Sink Effect for Mavrilimumab Following Intravenous Administration in Patients With Rheumatoid Arthritis

(2011) Bing Wang et al.   JOURNAL OF CLINICAL PHARMACOLOGY

PET with the 89Zr-Labeled Transforming Growth Factor-  Antibody Fresolimumab in Tumor Models

(2011) T. H. Oude Munnink et al.   JOURNAL OF NUCLEAR MEDICINE

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

Investigation of the Pharmacokinetics of Romiplostim in Rodents with a Focus on the Clearance Mechanism

(2011) Yow-Ming C. Wang et al.   PHARMACEUTICAL RESEARCH

Investigation of the Mechanism of Clearance of AMG 386, a Selective Angiopoietin-1/2 Neutralizing Peptibody, in Splenectomized, Nephrectomized, and FcRn Knockout Rodent Models

(2011) Benjamin Wu et al.   PHARMACEUTICAL RESEARCH

Unique challenges of providing bioanalytical support for biological therapeutic pharmacokinetic programs

(2011) William L Nowatzke et al.   Bioanalysis

Effects of Charge on Antibody Tissue Distribution and Pharmacokinetics

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

Biodistribution of 89Zr-trastuzumab and PET Imaging of HER2-Positive Lesions in Patients With Metastatic Breast Cancer

(2010) E C Dijkers et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Effect of Immune Complex Formation on the Distribution of a Novel Antibody to the Ovarian Tumor Antigen CA125

(2010) C. V. Pastuskovas et al.   DRUG METABOLISM AND DISPOSITION

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

The Application of Target Information and Preclinical Pharmacokinetic/Pharmacodynamic Modeling in Predicting Clinical Doses of a Dickkopf-1 Antibody for Osteoporosis

(2010) A. M. Betts et al.   JOURNAL OF PHARMACOLOGY AND EXPERIMENTAL THERAPEUTICS

Charge variants in IgG1

(2010) Leslie A. Khawli et al.   mAbs

Biodistribution Mechanisms of Therapeutic Monoclonal Antibodies in Health and Disease

(2009) Mohammad Tabrizi et al.   AAPS Journal

On Setting the First Dose in Man: Quantitating Biotherapeutic Drug-Target Binding through Pharmacokinetic and Pharmacodynamic Models

(2009) Philip J. Lowe et al.   BASIC & CLINICAL PHARMACOLOGY & TOXICOLOGY

Phase I Biodistribution and Pharmacokinetic Study of Lewis Y-Targeting Immunoconjugate CMD-193 in Patients with Advanced Epithelial Cancers

(2009) R. A. Herbertson et al.   CLINICAL CANCER RESEARCH

Pharmacological significance of glycosylation in therapeutic proteins

(2009) Huijuan Li et al.   CURRENT OPINION IN BIOTECHNOLOGY

Nonfucosylated rituximab potentiates human neutrophil phagocytosis through its high binding for FcγRIIIb and MHC class II expression on the phagocytotic neutrophils

(2009) Mami Shibata-Koyama et al.   EXPERIMENTAL HEMATOLOGY

Biodistribution of a Bispecific Single-chain Diabody and Its Half-life Extended Derivatives

(2009) Roland Stork et al.   JOURNAL OF BIOLOGICAL CHEMISTRY

Automated screening of monoclonal antibodies for SISCAPA assays using a magnetic bead processor and liquid chromatography-selected reaction monitoring-mass spectrometry

(2009) Regine M. Schoenherr et al.   JOURNAL OF IMMUNOLOGICAL METHODS

Physiologically based pharmacokinetic model for T84.66: A monoclonal anti-CEA antibody

(2009) Shweta R. Urva et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

The Pharmacologic Basis for Antibody-Auristatin Conjugate Activity

(2009) S. C. Alley et al.   JOURNAL OF PHARMACOLOGY AND EXPERIMENTAL THERAPEUTICS

Renal FcRn Reclaims Albumin but Facilitates Elimination of IgG

(2009) M. Sarav et al.   JOURNAL OF THE AMERICAN SOCIETY OF NEPHROLOGY

A modeling analysis of the effects of molecular size and binding affinity on tumor targeting

(2009) M. M. Schmidt et al.   MOLECULAR CANCER THERAPEUTICS

A recombinant polypeptide extends the in vivo half-life of peptides and proteins in a tunable manner

(2009) Volker Schellenberger et al.   NATURE BIOTECHNOLOGY

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

(2009) Royston Jefferis   TRENDS IN PHARMACOLOGICAL SCIENCES

Assessing Immunogenicity in the Presence of Excess Protein Therapeutic Using Immunoprecipitation and Quantitative Mass Spectrometry

(2008) Hendrik Neubert et al.   ANALYTICAL CHEMISTRY

Monoclonal Antibody Pharmacokinetics and Pharmacodynamics

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

N-Glycosylation as Novel Strategy to Improve Pharmacokinetic Properties of Bispecific Single-chain Diabodies

(2008) Roland Stork et al.   JOURNAL OF BIOLOGICAL CHEMISTRY

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

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

Molecular imaging in drug development

(2008) Jürgen K. Willmann et al.   NATURE REVIEWS DRUG DISCOVERY

Properties of the Glomerular Barrier and Mechanisms of Proteinuria

(2008) Börje Haraldsson et al.   PHYSIOLOGICAL REVIEWS

Podocytes use FcRn to clear IgG from the glomerular basement membrane

(2008) S. Akilesh et al.   PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA

A physiologically based pharmacokinetic (PBPK) model to characterize and predict the disposition of monoclonal antibody CC49 and its single chain Fv constructs

(2007) Jasmine P. Davda et al.   INTERNATIONAL IMMUNOPHARMACOLOGY