QPS Holdings, LLC
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Hear from a QPS Expert:
- 18 November 2020 Day 2 from 14:30-14:50 Fabrizia Fusetti, PhD will discuss Hybrid LC-MS assays for clinical development.
Fabrizia Fusetti, PhD Presents: “Development and validation of a Trastuzumab/Pertuzumab Hybrid LC-MS assay for clinical development”
Fabrizia Fusetti is the Scientific Director Bioanalysis at QPS Netherlands. Fabrizia obtained her PhD in Molecular Biology and Biotechnology at the University of Milan (Italy), after which she spent several years in academia and participated in numerous undamental and applied research projects mainly focused on the study of proteins. Her work contributed to over 50 peered reviewed publications. Before joining QPS in 2014, she started and managed one of the proteomics platforms at the University of Groningen. She is particularly interested in the development of mass spectrometry methods for bioanalysis of recombinant proteins, antibodies, ADCs, peptides and oligonucleotides.
The need for multiplex PK assay is growing together with the increasing use of multiple monoclonal antibodies (mAbs) in combination therapies. For the frequently co-administered anti-Human Epidermal growth factor Receptor 2 (HER2) mAbs trastuzumab and pertuzumab we developed a high-throughput and robust hybrid ligand-binding LC–MS/MS quantitative method. Nanomolar concentrations of trastuzumab and pertuzumab were determined after extraction by protein A affinity purification followed by trypsin digestion. The method, validated according to the current FDA/EMA guidelines for large molecule bioanalysis, was accurate and selective for the simultaneous determination of trastuzumab and pertuzumab in clinical samples, thereby overcoming the limitation of ligand binding assays that are challenged by mAbs targeting the same receptor. The assay was applied to support a late phase clinical study investigating the addition of co-administered trastuzumab and pertuzumab to standard curative treatments in esophageal cancer patients. The described generic bioanalytical strategy can easily be adapted to multiplex quantifications of other mAb combinations in non-clinical and clinical samples1.
- Schokker, S, Fusetti, F, Bonardi, F, Molenaar, RJ, Mathôt, RAA, van Laarhoven, HWM, (2020) Development and validation of an LC-MS/MS method for simultaneous quantification of co-administered trastuzumab and pertuzumab. mAbs 12 (1), 1795492.
- Martijn Hilhorst, PhD, Director LC-MS Small and Large Molecules, Presents: “Strategies for the prevention of non-specific binding in the quantitative determination of drugs in cerebrospinal fluid”
- Chris Williams, PhD, Study Director Large Molecule LC-MS, Bioanalysis & Drug Metabolism, Presents: “Development of a hybrid method for simultaneous quantification of two near identical proteins in plasma”
QPS has expanded its Phase I clinical trial capabilities by more than 20% and doubled its lab space, which will allow the CRO to accommodate ‘exponentially more sponsors’ as demand continues to increase
Clinical trials in the UK are reportedly declining as the country grapples with Brexit – a change which could make access to preclinical and bioanalytical research materials, including NHPs, problematic, says QPS
QPS is a GLP/GCP-compliant contract research organization (CRO) delivering the highest grade of discovery, preclinical, and clinical drug development services. Since 1995, it has rapidly expanded from a tiny bioanalysis shop to a full-service CRO with 1100+ employees in the US, Europe, India and Asia. Today, it offers expanded pharmaceutical contract R&D services with special expertise in Neuropharmacology, DMPK, Toxicology, Bioanalysis, Translational Medicine and all Phases of Clinical Development. QPS has CLIA-certified and GLP-compliant laboratories ready fast track your novel coronavirus and COVID-19 RT-qPCR/QPCR and Serological Assays, and vaccine or therapy development programs. An award-winning leader focused on bioanalytics and clinical trials, QPS is known for proven quality standards, technical expertise, a flexible approach to research, client satisfaction and turnkey laboratories and facilities. For more information, visit www.qps.com or email [email protected]. For more information on Covid-19 related projects, visit www.qps.com/coronavirus or email [email protected].
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Service areas and areas of focus:
- Biomarkers & Translational Medicine
- Cell & Gene Therapy
- ICP MS
- Small Molecules
- Method Development & Method Validation
- Early Phase Clinical Development
- Late Phase Clinical Development
- Clinical Research Services
- Dermal and Transdermal Research Services
- Drug Metabolism & Pharmacokinetics (DMPK)
- IND Package
- Study Recruitment
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