As interest increases in developing novel biomarker and biotherapeutic assays to support clinical development, so does the need to keep up with the pace of new discoveries and evolving fit-for-purpose methods.
One major challenge is that using enzyme-linked immunosorbent assay (ELISA) methods to quantify circulating levels of peptides and proteins, is not always sufficient due to issues with specificity. While using an MS-based approach to solve specificity challenges holds promise, it does not provide the same high level of sensitivity as current ELISA methods. Incorporating nanoLC/MS addresses sensitivity and selectivity, and new techniques can now be implemented to address robustness problems associated with nanoLC/MS.
This presentation will discuss how the LCMS Biomarkers and Biologics Services business at Quintiles has partnered with our sponsors to develop quantitative methods for biomarkers and biotherapeutics by adapting the immunoprecipitation methodologies of ELISA with the specificity and robustness of LCMS to achieve sensitivity that is comparable to ELISA but with the specificity of LCMS.
Using a bead-based immunoprecipitation extraction technique coupled with three dimensional, nanoflow liquid chromatography and electrospray ionization with triple quadrupole mass spectrometry, low picomolar detection limits are achieved for peptides and proteins. Some of these methods which have successfully validated with a lower limit of quantification (LLOQ) comparable or better than current ELISA assays will be highlighted.
Quintiles is the only clinical research organization (CRO) successfully employing immunoprecipitation techniques and three-dimensional LC/LC/nanoLC/MS/MS for the quantitation of biomarkers and biotherapeutics.
Gary Schultz, Ph.D., Director, LCMS Biomarkers and Biologics, Quintiles Bioanalytical and ADME Labs
Dr. Schultz joined Quintiles in 1997 and, since 2008, has led the LCMS Biomarkers and Biologics Services business. He is responsible for day-to-day management of the rapidly growing business and all sponsor project milestones relating to this service. Previously, Dr. Schultz led development and commercialization of microfluidic technologies at Advion BioSystems, Inc., now known as Advion, Inc. Dr. Schultz earned his Ph.D. in Analytical Chemistry from Michigan State University and his B.S. degree in Chemistry from the University of Wisconsin.
Who Should Attend?
EVPs, VPs, Directors, Heads, Managers, Scientists of:
- Clinical R&D
- Biomarker Development
- Drug Discovery
- Translational Research
- Clinical Operations (Clinical Project Leads, Clinical Program Managers, Therapeutic Heads, Clinical Data Managers, Pharmacovigilance Scientist)
- Regulatory Affairs
- Medical Affairs
- Outsourcing Management
Quintiles is the only fully integrated bioPharmaceutical services company offering clinical, commercial, and consulting solutions worldwide. The Quintiles network of more than 27,000 engaged professionals in 59 countries works with an unwavering commitment to patients, safety and ethics. Quintiles helps bioPharmaceutical companies navigate risk and seize opportunities in an environment where change is constant. For more information, please visit www.quintiles.com.