Intertek highlights bioanalytical and analytical solutions for antibody-drug conjugates at National Biotechnology Conference (AAPS NBC)

20 Jun 2014

Written by Intertek Pharmaceutical Services

Intertek, a leading quality solutions provider to industries worldwide, will highlight capabilities for analytical and bioanalytical solutions supporting product development of antibody-drug conjugates (ADCs) at the forthcoming American Association of Pharmaceutical Scientists – National Biotechnology Conference (AAPS NBC).

ADCs are monoclonal antibodies (mAb)linked via conjugation to a cytotoxic anti-cancer drug (typically a small molecule). This enables ADCs to offer highly selective delivery of the anti-cancer therapy.

During ADC production a range of ADCs will typically be produced differing in terms of the number of cytotoxic drug species attached to each mAb (described by the “drug-to-antibody ratio”). This variability presents a range of analytical and bioanalytical challenges to the overall product development.

Mike Buonarati, Senior Director, Intertek Pharmaceutical Services said, “ADCs incorporate both biological and small molecule components and so diverse analytical methods, including ligand-binding assays and liquid chromatography – mass spectrometry (LC-MS) methods are required to quantify these species in serum/plasma for pharmacokinetic studies and for assessing immunogenicity”.

Intertek experts will be on hand at Booth 215 during the NBC to discuss all aspects of ADC analysis and bioanalysis. Intertek provides complete bioanalytical capabilities for ADCs including quantitative bioanalytical assays for preclinical and clinical studies, total conjugated ADC assays, unconjugated (“free” drug) assays and Immunogenicity assessment.

Intertek’s ADC product analysis capabilities address all the expected heterogeneity features associated with a mAb and the variability introduced by the distribution of drug linked forms such as determination of drug-to-antibody ratios (DAR), assessment of attachment and structure, stability and quantification of unlinked mAb or unlinked drug.

The 2014 AAPS National Biotechnology Conference takes place May 19-21, in San Diego, USA.