Application of a Plug-and-Play Immunogenicity Assay in Cynomolgus Monkey Serum for ADCs at Early Stages of Drug Development

A fit-for-purpose strategy for the risk-based immunogenicity testing of biotherapeutics: a European industry perspective

(2015) Cathelijne Kloks et al.   JOURNAL OF IMMUNOLOGICAL METHODS

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

(2014) M. Benjamin Hock et al.   AAPS Journal

Innovative Use of LC-MS/MS for Simultaneous Quantitation of Neutralizing Antibody, Residual Drug, and Human Immunoglobulin G in Immunogenicity Assay Development

(2014) Hao Jiang et al.   ANALYTICAL CHEMISTRY

Sample Size Consideration for Immunoassay Screening Cut-Point Determination

(2014) Jianchun Zhang et al.   Journal of Biopharmaceutical Statistics

Recommendations for the characterization of immunogenicity response to multiple domain biotherapeutics

(2014) Boris Gorovits et al.   JOURNAL OF IMMUNOLOGICAL METHODS

Generation and characterization of a unique reagent that recognizes a panel of recombinant human monoclonal antibody therapeutics in the presence of endogenous human IgG

(2013) Xiangdan Wang et al.   mAbs

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

(2013) Montserrat Carrasco-Triguero et al.   Bioanalysis

Universal immunogenicity validation and assessment during early biotherapeutic development to support a green laboratory

(2013) Ami C Bautista et al.   Bioanalysis

Universal Immunoassay Applied During Early Development of Large Molecules to Understand Impact of Immunogenicity on Biotherapeutic Exposure

(2012) Ami C. Bautista et al.   AAPS Journal

Immunogenicity assessment in non-clinical studies

(2012) Steven J Swanson et al.   CURRENT OPINION IN MICROBIOLOGY

Evaluation of a generic immunoassay with drug tolerance to detect immune complexes in serum samples from cynomolgus monkeys after administration of human antibodies

(2010) Kay Stubenrauch et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Clinical immunogenicity specificity assessments: A platform evaluation

(2010) Kun Peng et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Evaluation of an immunoassay for human-specific quantitation of therapeutic antibodies in serum samples from non-human primates

(2009) Kay Stubenrauch et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

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