EBF 2020 – 13th Open Symposium

Since 2008 the European Bioanalysis Forum has been organizing an annual symposium that takes place in November. EBF 2020, the 13^th open symposium is no exception. Taking place on 17–20 November 2020 in cyberspace the symposium will feature a strong agenda focusing on the ‘power of science as our universal language’.

Organizers are now accepting abstract submissions for podium presentations and workshops in 5 categories. These categories include:

• New modalities – the changing portfolios. Which will cover new challenges for immunogenicity, regulatory challenges for new modalities and combination therapies.
• Technology – what is new on our doorstep. This includes HRMS, ultra-sensitive testing for chromatography and LBA, patient-centric sampling and automation.
• Method development as the scientific cornerstone of a robust assay. This includes the importance of method development, regulatory challenges and pharma/CRO method development.
• Compliance – feedback and trends. Which will cover feedback from industry, risk-based approach in regulated bioanalysis, GxP and ICH M10 updates.
• Old modalities. This topic will cover a new focus on continued challenges of small molecules, how technology combinations become the new standard to answer scientific questions and the added value of harmonized PK criteria.

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For more information, including registration and abstract submission guidelines, click here to visit the official EBF website.

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.

1. 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.

Posters:

• 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”