Discovery Bioanalysis: Current Challenges and Emerging Opportunities for Biologics Quantification by LC-MS

Over the past 20 years, protein and peptide drug development has evolved considerably and made a significant impact on the biotherapeutic market. This expansion into biologics has pushed pharmaceutical companies and contract research organizations (CROs) to explore new approaches for efficiently quantifying these large molecules to support high throughput, early stage pharmacokinetic (PK) studies. The gold standard has been ligand binding assays (LBA), but liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) is emerging as a promising alternative for biologics quantification.

Especially for compounds in early stages of drug development, LC-MS/MS offers multiple advantages over LBA such as multiplexing capability, higher selectivity, and faster method development. In addition, LC-MS/MS is an attractive alternative at early stages since the availability of specific reagents needed for LBA assays can be limited.

This webinar will highlight current challenges and emerging opportunities for the discovery environment. Key areas of focus will include:

• Factors affecting the choice of LBA or LC-MS/MS for biologics quantification
• Considerations when selecting a top-down or bottom-up LC-MS/MS workflow for biologics quantification in the discovery environment
• Factors that should be considered when choosing an extraction method for LC-MS/MS quantitation of biologics
• Best practices when developing a robust discovery level method without a validation
• Future opportunities for biologics quantification within the discovery bioanalytical space

Speakers

Salinda Wijeratne, PhD, Staff Scientist I, Discovery Bioanalytical, Covance

Among his many responsibilities, Salinda Wijeratne undertakes original research that includes developing and confirming highly sensitive, reliable assay methodologies for fast and accurate analysis of pharmaceuticals and biopharmaceuticals in biological fluids and tissues. He also plays a leadership role in developing scientific approaches for large and small molecule programs included in either preclinical or clinical drug development studies. Dr. Wijeratne has more than four years of experience in large molecule quantitation by LC-MS. Before his current position, he served as scientist of bioanalytical method development, at Charles River Labs and MPI Research. Author or co-author of several peer-reviewed journal publications, Dr. Wijeratne earned his PhD in Chemistry from Michigan State University. He joined Covance in February 2020.

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Lisa Geisler, PhD, Global Discovery Manager, Bioanalytical Chemistry, Covance

Based in Madison, Wisconsin, Lisa Geisler leads the global discovery bioanalytical team at sites in Madison and in Harrogate, United Kingdom. Dr. Geisler manages a broad spectrum of drug development study support for clients, including PK screening, ADME, ocular, non-GLP/lead optimization toxicology, safety assessment and clinical. She has held positions of increasing responsibility since joining the company in 2007. Her accomplishments include growing the Discovery business with the addition of the LCMS Large Molecule service line in 2018. Dr. Geisler brings 15 years of experience in drug development to Covance. Before joining the company, she served as senior scientist of process development for SAFC-Pharma (now MilliporeSigma) in Madison. Dr. Geisler earned her PhD in Organic Chemistry from Colorado State University.

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