Antibody–drug conjugates nonclinical support: from early to late nonclinical bioanalysis using ligand-binding assays

A White Paper—Consensus and Recommendations of a Global Harmonization Team on Assessing the Impact of Immunogenicity on Pharmacokinetic Measurements

(2014) J. M. Sailstad et al.   AAPS Journal

A Mechanistic Pharmacokinetic Model Elucidating the Disposition of Trastuzumab Emtansine (T-DM1), an Antibody–Drug Conjugate (ADC) for Treatment of Metastatic Breast Cancer

(2014) Brendan Bender et al.   AAPS Journal

Practical Considerations for the Pharmacokinetic and Immunogenic Assessment of Antibody–Drug Conjugates

(2014) Melody Sauerborn et al.   BIODRUGS

Mechanistic pharmacokinetic/pharmacodynamic modeling of in vivo tumor uptake, catabolism, and tumor response of trastuzumab maytansinoid conjugates

(2014) Russ Wada et al.   CANCER CHEMOTHERAPY AND PHARMACOLOGY

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

2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 3 – LBA and immunogenicity)

(2014) Lauren Stevenson et al.   Bioanalysis

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

Total Antibody Quantification for MMAE-Conjugated Antibody–Drug Conjugates: Impact of Assay Format and Reagents

(2013) Katherine R. Kozak et al.   BIOCONJUGATE CHEMISTRY

Location Matters: Site of Conjugation Modulates Stability and Pharmacokinetics of Antibody Drug Conjugates

(2013) Pavel Strop et al.   CHEMISTRY & BIOLOGY

Bioanalytical platform comparison using a generic human IgG PK assay format

(2013) Beth A. Leary et al.   JOURNAL OF IMMUNOLOGICAL METHODS

Site-specific antibody drug conjugates for cancer therapy

(2013) Siler Panowski et al.   mAbs

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

(2013) Randall Dere et al.   Bioanalysis

Discovery fit-for-purpose ligand-binding PK assays: what’s really important?

(2013) Lindsay E King 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

PK of immunoconjugate anticancer agent CMD-193 in rats: ligand-binding assay approach to determine in vivo immunoconjugate stability

(2013) Azher Hussain et al.   Bioanalysis

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

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

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

Pharmacokinetic Considerations for Antibody Drug Conjugates

(2012) Kedan Lin et al.   PHARMACEUTICAL RESEARCH

Bioanalytical Approaches to Quantify “Total” and “Free” Therapeutic Antibodies and Their Targets: Technical Challenges and PK/PD Applications Over the Course of Drug Development

(2011) Jean W. Lee et al.   AAPS Journal

Tunable Degradation of Maleimide–Thiol Adducts in Reducing Environments

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

Challenges in developing bioanalytical assays for characterization of antibody–drug conjugates

(2011) Jean Philippe Stephan et al.   Bioanalysis

Anti-CD22-MCC-DM1 and MC-MMAF Conjugates: Impact of Assay Format on Pharmacokinetic Parameters Determination

(2008) Jean-Philippe Stephan et al.   BIOCONJUGATE CHEMISTRY

Standard Operating Procedures for Serum and Plasma Collection: Early Detection Research Network Consensus StatementStandard Operating Procedure Integration Working Group

(2008) Melissa K. Tuck et al.   JOURNAL OF PROTEOME RESEARCH

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

(2008) Jagath R Junutula et al.   NATURE BIOTECHNOLOGY