Immunogenicity of Antibody Drug Conjugates: Bioanalytical Methods and Monitoring Strategy for a Novel Therapeutic Modality

Assessment and Reporting of the Clinical Immunogenicity of Therapeutic Proteins and Peptides—Harmonized Terminology and Tactical Recommendations

(2014) G. Shankar et al.   AAPS Journal

Measurement of in Vivo Drug Load Distribution of Cysteine-Linked Antibody–Drug Conjugates Using Microscale Liquid Chromatography Mass Spectrometry

(2014) Shawna Mae Hengel et al.   ANALYTICAL CHEMISTRY

Assessment of Physical Stability of an Antibody Drug Conjugate by Higher Order Structure Analysis: Impact of Thiol- Maleimide Chemistry

(2014) Jianxin Guo et al.   PHARMACEUTICAL RESEARCH

Safety and Clinical Activity of a Combination Therapy Comprising Two Antibody-Based Targeting Agents for the Treatment of Non-Hodgkin Lymphoma: Results of a Phase I/II Study Evaluating the Immunoconjugate Inotuzumab Ozogamicin With Rituximab

(2013) Luis Fayad et al.   JOURNAL OF CLINICAL ONCOLOGY

Key bioanalytical measurements for antibody–drug conjugate development: PK/PD modelers’ perspective

(2013) Dhaval K Shah et al.   Bioanalysis

Insights into antibody–drug conjugates: bioanalysis and biomeasures in discovery

(2013) Tracey Clark et al.   Bioanalysis

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

(2013) Montserrat Carrasco-Triguero et al.   Bioanalysis

Characterization of critical reagents in ligand-binding assays: enabling robust bioanalytical methods and lifecycle management

(2013) Brian J Geist 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

Immunogenicity testing strategy and bioanalytical assays for antibody–drug conjugates

(2013) Sarah A Hoofring et al.   Bioanalysis

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

(2013) Surinder Kaur et al.   Bioanalysis

Ligand Binding Assays in the 21st Century Laboratory: Recommendations for Characterization and Supply of Critical Reagents

(2012) Denise M. O’Hara et al.   AAPS Journal

Antibody-Drug Conjugates in Cancer Therapy

(2012) Eric L. Sievers et al.   Annual Review of Medicine

Clinical pharmacology of trastuzumab emtansine (T-DM1): an antibody–drug conjugate in development for the treatment of HER2-positive cancer

(2012) Sandhya Girish et al.   CANCER CHEMOTHERAPY AND PHARMACOLOGY

Phase 1, open-label study of MEDI-547 in patients with relapsed or refractory solid tumors

(2012) Christina M. Annunziata et al.   INVESTIGATIONAL NEW DRUGS

Phase I Multidose-Escalation Study of the Anti-CD19 Maytansinoid Immunoconjugate SAR3419 Administered by Intravenous Infusion Every 3 Weeks to Patients With Relapsed/Refractory B-Cell Lymphoma

(2012) Anas Younes et al.   JOURNAL OF CLINICAL ONCOLOGY

Targeting the Hemoglobin Scavenger receptor CD163 in Macrophages Highly Increases the Anti-inflammatory Potency of Dexamethasone

(2012) Jonas H Graversen et al.   MOLECULAR THERAPY

Pharmacokinetic Considerations for Antibody Drug Conjugates

(2012) Kedan Lin et al.   PHARMACEUTICAL RESEARCH

Identification and elimination of an immunodominant T-cell epitope in recombinant immunotoxins based on Pseudomonas exotoxin A

(2012) R. Mazor et al.   PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA

Tunable Degradation of Maleimide–Thiol Adducts in Reducing Environments

(2011) Aaron D. Baldwin et al.   BIOCONJUGATE CHEMISTRY

Phase I studies of AVE9633, an anti-CD33 antibody-maytansinoid conjugate, in adult patients with relapsed/refractory acute myeloid leukemia

(2011) Simona Lapusan et al.   INVESTIGATIONAL NEW DRUGS

Analytical methods for physicochemical characterization of antibody drug conjugates

(2011) Aditya Wakankar et al.   mAbs

Loss of CD4 T-cell-dependent tolerance to proteins with modified amino acids

(2011) V. Gauba et al.   PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA

Physicochemical Stability of the Antibody−Drug Conjugate Trastuzumab-DM1: Changes due to Modification and Conjugation Processes

(2010) Aditya A. Wakankar et al.   BIOCONJUGATE CHEMISTRY

The effect of antibody isotype and antigenic epitope density on the complement-fixing activity of immune complexes: a systematic study using chimaeric anti-NIP antibodies with human Fc regions

(2010) Y. M. LUCISANO VALIM et al.   CLINICAL AND EXPERIMENTAL IMMUNOLOGY

A systematic study of neutrophil degranulation and respiratory burst in vitro by defined immune complexes

(2010) W. ZHANG et al.   CLINICAL AND EXPERIMENTAL IMMUNOLOGY

The Pharmacologic Basis for Antibody-Auristatin Conjugate Activity

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

Immunostimulatory activity of haptenated proteins

(2009) N. W. Palm et al.   PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA

Contribution of Linker Stability to the Activities of Anticancer Immunoconjugates

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

Cantuzumab mertansine in a three-times a week schedule: a phase I and pharmacokinetic study

(2008) Jordi Rodon et al.   CANCER CHEMOTHERAPY AND PHARMACOLOGY

Antibody-Drug Conjugates for Cancer Therapy

(2008) Paul J. Carter et al.   CANCER JOURNAL

Phase I Trial of the Prostate-Specific Membrane Antigen–Directed Immunoconjugate MLN2704 in Patients With Progressive Metastatic Castration-Resistant Prostate Cancer

(2008) Matthew D. Galsky et al.   JOURNAL OF CLINICAL ONCOLOGY

Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products

(2008) Eugen Koren et al.   JOURNAL OF IMMUNOLOGICAL METHODS

Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products

(2008) Gopi Shankar et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Cetuximab-Induced Anaphylaxis and IgE Specific for Galactose-α-1,3-Galactose

(2008) Christine H. Chung et al.   NEW ENGLAND JOURNAL OF MEDICINE