2021 – EBF Cyberconnect Events:
Program of EBF Focus Workshop “Peptides & Proteins with (LC-)MS” 17-18 June 2021
PDF renditions of the powerpoint presentations given at the Focus Workshop can be viewed and downloaded from this page. The program itself can be viewed and downloaded by clicking here
| Day 1 (all times in CET, Brussels Time Zone) | |||
| 12:30 | 12:45 | Coming online | |
| 12:45 | 13:00 | Getting started – Welcome Philip Timmerman – EBF |
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| 13:00 | 13:20 | Introduction to the workshop | |
| Matthew Barfield – on behalf of the EBF | |||
| Why this workshop? | |||
| 13:20 | 14:40 | Session 1 – Scientific Challenges (e.g. reagents, free total, intact vs digested) | |
| 13:20 | 13:40 | Carsten Krantz – Novartis | |
| Hybrid LBA-LCMS for ADA detection | |||
| 13:40 | 14:00 | Daniel Vidler – Arcinova – A Quotient Sciences Business | |
| Identifying Peptide Markers From Mycobacterial Protein Digests – Development of a High-Resolution LC-MS Assay | |||
| 14:00 | 14:20 | Matthias Sury – Celerion | |
| Key Reagent Release Testing by LC-HRMS | |||
| 14:20 | 14:40 | Chris Williams – QPS | |
| Development of a hybrid method for quantification of a therapeutic protein differing by a single amino acid from the endogenous form | |||
| 14:40 | 15:10 | Break | |
| 15:10 | 18:30 | Session 2: Scientific developments (new tools) | |
| 15:10 | 15:30 | Julien Peltier – GlaxoSmithKline | |
| Characterisation and Quantification of Therapeutic Antibodies by Incorporating Response Bias Correction using Affinity Capture and Intact Protein LC-MS. | |||
| 15:30 | 15:50 | Ke Li – Frontage Labs | |
| Development and validation of a LC/MS method for the quantification of fascin in human serum | |||
| 15:50 | 16:10 | Thomas Schneider – BiognoSYS AG (not released for publication) | |
| Context of Use Validation of a Data Independent Acquisition based Deep Proteome Quantification Approach | |||
| 16:10 | 16:30 | Lei Xiong – Sciex | |
| Improved LC-MRM workflow for cyclic peptide quantification on natriuretic peptide family | |||
| 16:30 | 16:40 | Short Q&A | |
| Short logistic break | |||
| 17:00 | 17:20 | James Marr – MSD | |
| Improvements in Immunoprecipitation and Digestion Efficiencies for Monoclonal Antibodies in Pharmacokinetic Studies using LC-MS/MS for Analysis | |||
| 17:20 | 17:40 | Szabolcs Szarka – LGC | |
| Utilizing high-resolution mass spectrometry to improve the sensitivity of a therapeutic protein assay | |||
| 17:40 | 18:00 | Anton Rosenbaum – AstraZeneca | |
| Comparison of Bioanalytical Methods for Pharmacokinetic Assessments of ADC | |||
| 18:00 | 18:30 | Session 2 Q&A | |
| 18:30 | End of Day 1 | ||
| Day 2 (all times in CET, Brussels Time Zone) | |||
| 12:45 | 13:00 | Coming online | |
| 13:00 | 14:30 | Session 3: how to interpret the data (e.g. biological specificity vs. analytical specificity, which data are ‘true’? | |
| 13:00 | 13:10 | Philip Timmerman – EBF | |
| Introduction to the session: Turning Scientific challenges challenges into opportunities | |||
| 13:10 | 13:30 | Oriol Peris Serrano – Charles River Laboratories | |
| The Impact of Assay Acceptance Criteria on Derived Data – Pharmacokinetic Assessment Through Simulation | |||
| 13:30 | 13:50 | Gregor Jordan – F. Hoffmann-La Roche | |
| Is correct quantification of free/active drug concentrations by hybrid LC-MS possible? An evaluation applying the “free analyte QC concept” | |||
| 13:50 | 14:10 | Nico van de Merbel – PRA-HS/U. Groningen | |
| Analytical consequences of the in vivo deamidation of trastuzumab and pertuzumab: comparison of the results of three bioanalytical platforms | |||
| 14:10 | 14:30 | Session 3 Q&A and panel discussion | |
| 14:30 | 14:50 | Break | |
| 14:50 | 16:20 | Session 4 – Defining a bioanalytical strategy for peptide/protein: which assay when and why? | |
| 14:50 | 15:00 | Iain Love – on behalf of the EBF | |
| Introduction to the session: Questions to consider when buidling a bioanalytical strategy for proteins | |||
| 15:00 | 15:20 | Rita Martello – Merck KGaA | |
| How to develop a bionalaytical strategy for therapeutic proteins | |||
| 15:20 | 15:40 | Shashank Gorityala – Covance (not released for publication) | |
| LCMS-based strategies for the quantitation of protein biotherapeutics | |||
| 15:40 | 16:00 | Emmanuel Njumbe Ediage, Janssen R&D | |
| Challenges in developing an LC-MS/MS assay for the quantification of Pegasys; what are we measuring? | |||
| 16:00 | 16:20 | Session 4 Q&A and panel discussion | |
| 16:20 | 16:40 | Break | |
| 16:40 | 18:20 | Session 5 – Regulatory challenges – experience and industry recommendations | |
| 16:40 | 17:00 | Amanda Wilson – on behalf of the EBF | |
| Introduction to the session: EBF FB from the survey | |||
| 17:00 | 17:20 | Case studies & scientific and regulatory challenges on combining MS and LBA | |
| Tsvetelina Ivanova, Comac-Medical | |||
| Pharmacokinetic analysis using LBA and MS concentration data – was this a real challenge? | |||
| 17:20 | 17:40 | William Mylott, PPD | |
| Bioanalytical Method Validations: Taking a ‘Hybrid Approach’ | |||
| 17:40 | 18:00 | Eric Thomas, Covance by Labcorp | |
| Perspectives on Performance and Requirements for Protein MS Assays | |||
| 18:00 | 18:20 | Closing Panel discussion: where regulatory and scientific challegens for protein analysis meet. | |
| 18:20 | Closing comments and Adjourn | ||
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Organising Committee: : Matthew Barfield (Roche), Anna Laurén (NovoNordisk), Robert Nelson (Covance), Johannes Stanta (Freeline Therapeutics) and Philip Timmerman (EBF) |
