European Bioanalysis Forum

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
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
Organising Committee: : Matthew Barfield (Roche), Anna Laurén (NovoNordisk), Robert Nelson (Covance), Johannes Stanta (Freeline Therapeutics) and Philip Timmerman (EBF)
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