Bioanalytical approaches for characterizing catabolism of antibody–drug conjugates

The cryptophycins as potent payloads for antibody drug conjugates

(2015) Vishal A. Verma et al.   BIOORGANIC & MEDICINAL CHEMISTRY LETTERS

The role of protein and peptide separation before mass spectrometry analysis in clinical proteomics

(2015) Serena Camerini et al.   JOURNAL OF CHROMATOGRAPHY A

Characterization of antibody drug conjugate positional isomers at cysteine residues by peptide mapping LC–MS analysis

(2015) Marie-Claire Janin-Bussat et al.   JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES

Metabolites of Antibody–Maytansinoid Conjugates: Characteristics and in Vitro Potencies

(2015) Wayne Widdison et al.   MOLECULAR PHARMACEUTICS

An FDA oncology analysis of antibody-drug conjugates

(2015) Haleh Saber et al.   REGULATORY TOXICOLOGY AND PHARMACOLOGY

Fabrication of an on-line enzyme micro-reactor coupled to liquid chromatography–tandem mass spectrometry for the digestion of recombinant human erythropoietin

(2015) Hsiao Ching Foo et al.   TALANTA

Innovative Native MS Methodologies for Antibody Drug Conjugate Characterization: High Resolution Native MS and IM-MS for Average DAR and DAR Distribution Assessment

(2014) François Debaene et al.   ANALYTICAL CHEMISTRY

Aldehyde Tag Coupled with HIPS Chemistry Enables the Production of ADCs Conjugated Site-Specifically to Different Antibody Regions with Distinct in Vivo Efficacy and PK Outcomes

(2014) Penelope M. Drake et al.   BIOCONJUGATE CHEMISTRY

Development of Novel ADCs: Conjugation of Tubulysin Analogues to Trastuzumab Monitored by Dual Radiolabeling

(2014) R. Cohen et al.   CANCER RESEARCH

Potential Mechanisms for Thrombocytopenia Development with Trastuzumab Emtansine (T-DM1)

(2014) H. Uppal et al.   CLINICAL CANCER RESEARCH

FDA Approval: Ado-Trastuzumab Emtansine for the Treatment of Patients with HER2-Positive Metastatic Breast Cancer

(2014) L. Amiri-Kordestani et al.   CLINICAL CANCER RESEARCH

An industry perspective on tiered approach to the investigation of metabolites in drug development

(2014) Su-Er W Huskey et al.   Bioanalysis

2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 2 – hybrid LBA/LCMS, ELN & regulatory agencies’ input)

(2014) Dawn Dufield et al.   Bioanalysis

Site-specific antibody drug conjugates for cancer therapy

(2013) Siler Panowski et al.   mAbs

Antibody-drug conjugates

(2013) Alain Beck et al.   mAbs

Methods for site-specific drug conjugation to antibodies

(2013) Christopher R Behrens et al.   mAbs

Antibody-drug conjugate model fast characterization by LC-MS following IdeS proteolytic digestion

(2013) Elsa Wagner-Rousset et al.   mAbs

In-depth qualitative and quantitative analysis of composite glycosylation profiles and other micro-heterogeneity on intact monoclonal antibodies by high-resolution native mass spectrometry using a modified Orbitrap

(2013) Sara Rosati et al.   mAbs

Large-scale identification of ubiquitination sites by mass spectrometry

(2013) Namrata D Udeshi et al.   Nature Protocols

Site-specific chemical modification of antibody fragments using traceless cleavable linkers

(2013) Gonçalo J L Bernardes et al.   Nature Protocols

Maturing antibody–drug conjugate pipeline hits 30

(2013) Asher Mullard   NATURE REVIEWS DRUG DISCOVERY

PK assays for antibody–drug conjugates: case study with ado-trastuzumab emtansine

(2013) Randall Dere et al.   Bioanalysis

Characterization of the drug-to-antibody ratio distribution for antibody–drug conjugates in plasma/serum

(2013) Keyang Xu et al.   Bioanalysis

Bioanalysis of antibody–drug conjugates: American Association of Pharmaceutical Scientists Antibody–Drug Conjugate Working Group position paper

(2013) Boris Gorovits et al.   Bioanalysis

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

(2013) Surinder Kaur et al.   Bioanalysis

Absorption, Distribution, Metabolism, and Excretion (ADME) Studies of Biotherapeutics for Autoimmune and Inflammatory Conditions

(2012) Yulia Vugmeyster et al.   AAPS Journal

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

(2012) Xin Xu et al.   AAPS Journal

Characterization of Therapeutic Antibodies and Related Products

(2012) Alain Beck et al.   ANALYTICAL CHEMISTRY

An integrated approach to identify normal tissue expression of targets for antibody-drug conjugates: case study of TENB2

(2012) C Andrew Boswell et al.   BRITISH JOURNAL OF PHARMACOLOGY

Antibody-Drug Conjugates for the Treatment of Cancer

(2012) John A. Flygare et al.   Chemical Biology & Drug Design

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

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

U.S. Food and Drug Administration Approval Summary: Brentuximab Vedotin for the Treatment of Relapsed Hodgkin Lymphoma or Relapsed Systemic Anaplastic Large-Cell Lymphoma

(2012) R. A. de Claro et al.   CLINICAL CANCER RESEARCH

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

Fourth World Antibody-Drug Conjugate Summit

(2012) Alain Beck et al.   mAbs

Targeted Data Extraction of the MS/MS Spectra Generated by Data-independent Acquisition: A New Concept for Consistent and Accurate Proteome Analysis

(2012) Ludovic C. Gillet et al.   MOLECULAR & CELLULAR PROTEOMICS

Abstract A136: Nonclinical disposition, metabolism, and in vitro drug-drug interaction assessment of DM1, a component of trastuzumab emtansine (T-DM1).

(2012) S. Wong et al.   MOLECULAR CANCER THERAPEUTICS

The Effect of Different Linkers on Target Cell Catabolism and Pharmacokinetics/Pharmacodynamics of Trastuzumab Maytansinoid Conjugates

(2012) H. K. Erickson et al.   MOLECULAR CANCER THERAPEUTICS

Conjugation site modulates the in vivo stability and therapeutic activity of antibody-drug conjugates

(2012) Ben-Quan Shen et al.   NATURE BIOTECHNOLOGY

Characterization of intact antibody–drug conjugates from plasma/serum in vivo by affinity capture capillary liquid chromatography–mass spectrometry

(2011) Keyang Xu et al.   ANALYTICAL BIOCHEMISTRY

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

Human kappa light chain targeted Pseudomonas exotoxin A — identifying human antibodies and Fab fragments with favorable characteristics for antibody–drug conjugate development

(2011) C. Kellner et al.   JOURNAL OF IMMUNOLOGICAL METHODS

Stable isotope-resolved metabolomics and applications for drug development

(2011) Teresa W.-M. Fan et al.   PHARMACOLOGY & THERAPEUTICS

Effects of Charge on Antibody Tissue Distribution and Pharmacokinetics

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

Detecting low level sequence variants in recombinant monoclonal antibodies

(2010) Yi Yang et al.   mAbs

Early human ADME using microdoses and microtracers: bioanalytical considerations

(2010) Stephen R Dueker et al.   Bioanalysis

Targeted cytotoxic therapy: adapting a rapidly progressing anticancer paradigm for depletion of persistent HIV-infected cell reservoirs

(2010) Edward A Berger   Current Opinion in HIV and AIDS

The Pharmacologic Basis for Antibody-Auristatin Conjugate Activity

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

Contribution of Linker Stability to the Activities of Anticancer Immunoconjugates

(2008) Stephen C. Alley et al.   BIOCONJUGATE CHEMISTRY

Site-specific conjugation of a cytotoxic drug to an antibody improves the therapeutic index

(2008) Jagath R Junutula et al.   NATURE BIOTECHNOLOGY

Mass defect profiles of biological matrices and the general applicability of mass defect filtering for metabolite detection

(2008) Haiying Zhang et al.   RAPID COMMUNICATIONS IN MASS SPECTROMETRY