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

General LC-MS/MS Method Approach to Quantify Therapeutic Monoclonal Antibodies Using a Common Whole Antibody Internal Standard with Application to Preclinical Studies

(2012) Hongyan Li et al.   ANALYTICAL CHEMISTRY

Native Intact Mass Determination of Antibodies Conjugated with Monomethyl Auristatin E and F at Interchain Cysteine Residues

(2012) John F. Valliere-Douglass et al.   ANALYTICAL CHEMISTRY

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

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

Overcoming soluble target interference in an anti-therapeutic antibody screening assay for an antibody–drug conjugate therapeutic

(2012) Montserrat Carrasco-Triguero et al.   Bioanalysis

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

Antibody Conjugate Therapeutics: Challenges and Potential

(2011) B. A. Teicher et al.   CLINICAL CANCER RESEARCH

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

(2011) Jean Philippe Stephan et al.   Bioanalysis

Antibody–drug conjugates: targeted drug delivery for cancer

(2010) Stephen C Alley et al.   CURRENT OPINION IN CHEMICAL BIOLOGY

Phase I Study of Trastuzumab-DM1, an HER2 Antibody-Drug Conjugate, Given Every 3 Weeks to Patients With HER2-Positive Metastatic Breast Cancer

(2010) Ian E. Krop et al.   JOURNAL OF CLINICAL ONCOLOGY

Phase II Study of the Antibody Drug Conjugate Trastuzumab-DM1 for the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2) –Positive Breast Cancer After Prior HER2-Directed Therapy

(2010) Howard A. Burris et al.   JOURNAL OF CLINICAL ONCOLOGY

Bioanalysis of recombinant proteins and antibodies by mass spectrometry

(2009) Eric Ezan et al.   ANALYST

Tumor Delivery and In Vivo Processing of Disulfide-Linked and Thioether-Linked Antibody−Maytansinoid Conjugates

(2009) Hans K. Erickson et al.   BIOCONJUGATE CHEMISTRY

Contribution of Linker Stability to the Activities of Anticancer Immunoconjugates

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

Antibody-Drug Conjugates for Cancer Therapy

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

Targeting HER2-Positive Breast Cancer with Trastuzumab-DM1, an Antibody-Cytotoxic Drug Conjugate

(2008) G. D. Lewis Phillips et al.   CANCER RESEARCH

Rapid identification of reactive cysteine residues for site-specific labeling of antibody-Fabs

(2008) Jagath R. Junutula et al.   JOURNAL OF IMMUNOLOGICAL METHODS

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

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

(2008) Jagath R Junutula et al.   NATURE BIOTECHNOLOGY

Targeted Cancer Therapy: Conferring Specificity to Cytotoxic Drugs

(2007) Ravi V. J. Chari   ACCOUNTS OF CHEMICAL RESEARCH