In a 20 year span LC-MS has transitioned from an enabling to an essential tool in the pharmaceutical industry.  Applications span from discovery analytics to commercial QC, from biologics to small molecules, and from characterization to quantitation to isolation.  This talk will provide an overview of how Genentech has used various LC-MS methodology to support a diverse development pipeline.  <br/>The most appropriate mass selection and ionization mode must be chosen to meet the quantitation and selectivity requirements of the analysis. The relatively straightforward task of quantitating known trace level potential genotoxic impurities (PGIs) in traditional small molecule API or formulation matrices can is often best accomplished using LC coupled with triple-quad systems.  Identifying and quantitating deactivated analogs of a high-potency drugs prior to cleaning, monitoring bioconjugate reactions, or monitoring equipment cleaning, for example, have other considerations and requires new approaches.  The application of LC-MS to support next generation hybrid biologic-small molecule therapeutic modalities such as Antibody-Drug Conjugates, (ADCs), provides both challenge and opportunity.  Example trace LC-MS applications for various drug modalities and development workstreams will be presented including trace analysis of active linker-drug in isolated ADC, formulated ADC products, and cleaning samples

Trace quantitation of PGIs at ICH M7 limits and beyond: Using LC-MS to support next generation oncology modalities

252nd National Meeting (2016)

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