Program

 

 

Day 0 – 20 JUNE 2011

 

 

 

16:00

20:00

Registration and Information Desk Open

 

 

 

 

 

Day 1 - 21 JUNE 2011

 

 

 

07.30

12:30

Registration and Information Desk Open

 

 

 

08.45

09.00

Welcome and Introduction

 

 

 

09.00

12.30

New Technology Developments for Analysis of Large Molecules

 

 

 

09.00

10.30

Session 1: New Instrument Developments

 

 

Chair: Berthold Lausecker, CRS Mannheim

 

 

 

09.00

09.30

Comparison of different MS platforms for peptide quantification

 

 

Lieve Dillen, Janssen R&D

 

 

 

09.30

09.50

Implementation of a common high pH LC/MS/MS platform for small molecules and large molecules

 

 

Robert Plumb, Waters Corporation

 

 

 

09.50

10.10

Introducing a novel bench top Orbitrap for highly selective peptide/protein quantitation

 

 

Kai Scheffler, Thermo Fisher Scientific

 

 

 

10.10

10.30

High Sensitivity Protein Quantitation Using a Triple Quadrupole with a Dual Ion Funnel

 

 

Lester Taylor, Agilent Technologies

 

 

 

10.30

11.00

Coffee Break

 

 

 

11.00

15.00

Cutting Edge Analytical Approaches

 

 

Chair: Silke Luedtke, Boehringer-Ingelheim

 

 

 

11.00

12.30

Session 2a: Cutting Edge Analytical Approaches - Peptides

 

 

 

11.00

11.30

Strategies for the analysis of therapeutic peptides in biofluids

 

 

Lee Goodwin, Covance

 

 

 

11.30

11.50

Comparison of clinical analyser and LC-MS/MS based approaches for quantification of serum IGF-I levels

 

 

Rachel Green, Quotient Bioresearch

 

 

 

11.50

12.10

Quantitative LC-MS/MS analysis of polypeptides: glucagon

 

 

Veniamin Lapko, Celerion

 

 

 

12.10

12.30

Quantification of selected peptides in biological fluids e.g. plasma

 

 

Hermann Mascher, pharm-analyt Lab. GmbH

 

 

 

12.30

13.30

Lunch

 

 

 

13.30

15.00

Session 2b: Cutting Edge Analytical Approaches - Peptides

 

 

Chair: Silke Luedtke, Boehringer-Ingelheim

 

 

 

13.30

14.00

The importance of sample preparation for the analysis of proteins and peptides by liquid chromatography with mass spectrometric detection

 

 

Gerard Hopfgartner, University of Geneva

 

 

 

14.00

14.30

LC-MS/MS bioanalysis of therapeutic peptides in plasma at low pg/mL levels

 

 

Magnus Knutsson, Ferring Pharmaceuticals A/S

 

 

 

14.30

15.00

A selective SPE/LC-MS/MS assay for simultaneous quantitation of multiple amyloid beta peptides in cerebrospinal fluid

 

 

Erin Chambers, Waters Corporation

 

 

 

15.00

15.30

Coffee Break

 

 

 

15.30

18.00

Validation Requirements for Large Molecule Analysis with MS Techniques

 

 

 

15.30

18.00

Session 3: Regulatory Challenges and Acceptance Criteria

 

 

Chair: Berthold Lausecker, CRS Mannheim

 

 

 

15.30

15.50

First EBF reflections on Method validation criteria for peptide/protein analysis with LC-MS based techniques

 

 

Philip Timmerman, Janssen R&D

 

 

 

15.50

16.20

Validation of an immunoprecipitation, digestion and immunoaffinity LC-MS/MS assay for human NGF biomarker and implementation in support of clinical trials

 

 

Gary Schulz, Advion Bioservices

 

 

 

16.20

16.40

The use of internal standards for macromolecule quantification by LC-MS: lessons learned from small molecule assays

 

 

Nico van de Merbel, PRA International

 

 

 

16.40

17.00

Issues of specificity, recovery, and accuracy in LC-MS/MS assays for peptides and proteins (working title)

 

 

Ben van Baar, QPS

 

 

 

17.00

18.00

Panel Discussion

 

 

 

18.00

19.00

Cocktail Reception

 

 

 

 

 

 

 

 

Day 2 - 22 JUNE 2011

 

 

 

08.30

12.00

Cutting Edge Analytical Approaches - Proteins

 

 

Chair: Begona Barroso, Astellas

 

 

 

08.30

10.00

Session 4a: Cutting Edge Analytical Approaches - Proteins

 

 

 

08.30

09.00

The powers of using MRM3 and high resolution MS with fast scan rates to conquer previously difficult large molecule compounds

 

 

Yong-Xi Li, Medpace Bioanalytical Laboratories

 

 

 

09.00

09.30

LC-MS/MS quantification of proteins and peptides in biological fluids: towards a generic approach

 

 

Olivier Heudi, Novartis Pharma AG

 

 

 

09.30

10.00

High throughput method for the quantitative analysis of therapeutic antibody in the low ng/mL range from serum samples via affinity enrichment coupled LC-MS/MS to support clinical and preclinical PK/TK evaluation

 

 

Stephanie Fischmann, Abbott

 

 

 

10.00

10.30

Coffee Break

 

 

 

10.30

12.00

Session 4b: Cutting Edge Analytical Approaches - Proteins

 

 

Chair: Begona Barroso, Astellas

 

 

 

10.30

10.50

Sample preparation for protein quantification by LC-MS/MS

 

 

Ejvind Mørtz, Alphalyse

 

 

 

10.50

11.10

Challenges in validating protein and peptide LC-MS/MS methodologies

 

 

Ian Ward, Quotient Bioresearch

 

 

 

11.10

11.30

Comparison of quantitative assays for a large protein: ELISA vs. LC-MS/MS

 

 

Alberto Guenzi, Hoffmann-La Roche

 

 

 

11.30

12.00

Development and validation of an immunoaffinity-LC-MS/MS assay for 22 KDa somatropin in human serum (working title)

 

 

Rand Jenkins, PPD

 

 

 

11.50

13.00

Lunch

 

 

 

13.00

14.30

Analytical Strategy

 

 

 

13.00

14.30

Session 5: Analytical Strategies on Combining LBA and LC-MS(/MS) for Large Molecules

 

 

Chair: Peter van Amsterdam, Abbott Healthcare Products

 

 

 

13.00

13.30

The sense and nonsense of quantitative analysis of biologics - or why should we care

 

 

Martin Nemansky, PRA International

 

 

 

13.30

14.00

Ligand Binding Assay critical reagent characterization via LC-MS

 

 

Brian Geist, Centocor

 

 

 

14.00

14.30

Highly sensitive Cytokine Quantification using Imperacer®, an Immuno-PCR based Ligand-Binding Assay System

 

 

Michael Adler, Chimera Biotec GmbH

 

 

 

14.30

15.00

Coffee Break

 

 

 

15.00

16.30

Proteins in the MIST

 

 

 

15.00

16.30

Session 6: Proteins in the MIST

 

 

Chair: Peter van Amsterdam, Abbott Healthcare Products

 

 

 

15.00

15.30

Ion mobility mass spectrometry: New molecular tool for the analysis of reactive intermediates in the oligomerization- aggregation of “misfolding”-aggregating proteins

 

 

Michael Przybylski, University of Konstanz

 

 

 

15.30

15.50

Strategies for quantifying plasma protease susceptible peptides by LC-MS/MS

 

 

Richard Kay, Quotient Bioresearch

 

 

 

15.50

16.10

Bioanalytical LC-MS of therapeutic oligonucleotides

 

 

William van Dongen, PROXY laboratories

 

 

 

16.10

16.30

Extracting metabolite ions of peptide drugs out of an in vivo matrix background

 

 

Filip Cuyckens, Janssen R&D

 

 

 

16.30

 

Closing Remarks and Adjourn

 


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