AT Europe 2015

Analytical Technologies Europe:
Symposium on the Practical Applications
including CE, LC and MS in the
Biopharmaceutical Industry
(AT Europe 2015)
Symposium Co-Chairs:
Cari Sänger - van de Griend, Kantisto BV
Hansjörg Toll, Sandoz GmbH
17-20 March, 2015
The Westin Grand Berlin
Berlin, Germany
Organized by
Table of Contents
Program Partners, Exhibitors and Media Partners .................................................................
Student Travel Grants ............................................................................................................
Acknowledgements ................................................................................................................
Scientific Final Program Summary ........................................................................................
Session Abstracts....................................................................................................................
Workshop I Description .........................................................................................................
Technical Seminar Abstract ...................................................................................................
Poster Abstracts .....................................................................................................................
2
The Organizing Committee gratefully acknowledges the following program partners
for their generous support of this Symposium:
Sustaining Platinum Program Partner
MedImmune
Platinum Program Partner
Genedata GmbH
Gold Program Partner
Bruker Daltonik
Exhibitors
Agilent Technologies LSG
Bruker Daltonik
Europa Bioproducts Ltd.
Genedata GmbH
Genovis AB
Postnova Analytics GmbH
Protagen Protein Services GmbH
ProteinSimple
SCIEX Separations, a part of AB SCIEX
Wyatt Technology Europe
3
Media Program Partners
The Analytical Scientist
BioProcess International
Genetic Engineering & Biotechnology News
International Pharmaceutical Quality
LCGC Europe
The Medicine Maker
The Pathologist
Royal Society of Chemistry
separationsNOW.com
Technology Networks Limited
Supporting Organization
Gesellschaft Deutscher Chemiker (GDCh)
4
CASSS AT Europe Student Travel Grants
CASSS is pleased to provide a limited number of student travel grants for PhD students and post-docs
who present applicable posters at the inaugural Analytical Technologies Europe: Symposium on the
Practical Applications including CE, LC and MS in the Biopharmaceutical Industry (AT Europe 2015).
PhD students or post-doctoral fellows conducting research at academia throughout the world are
eligible.
Why you should apply:
This Symposium is an active forum for discussion of recent developments and regulatory considerations
of the practical application of analytical technologies amongst industry, academia and regulatory
agencies. There will be a focus on capillary electrophoresis, mass spectrometry and chromatography for
product characterization, process monitoring, formulation development and release testing in the
biopharmaceutical industry. As a participant, you will have an excellent opportunity to meet, network
and participate in exchanging knowledge for mutual education with your peers.
How do you apply:
Please send a letter requesting consideration for the grant, a letter of recommendation from your
supervisor, proof of your university affiliation and a PDF of your abstract to the Symposium Manager
Renee Olson ([email protected]).
Application for a travel grant does not release you from the obligation to register and submit your
abstract online.
Requirements are:
Present a poster on a MS, CE, LC topics relating to Biopharmaceuticals
Proof of studentship/post-doc status
Recommendation from your supervisor
The deadline to apply for a student travel grant is Friday, 13 February 2015.
5
Acknowledgements
Symposium Co-Chairs:
Cari Sänger - van de Griend, Kantisto BV
Hansjörg Toll, Sandoz GmbH
Scientific Program Committee:
Martin Blüggel, Protagen Protein Services GmbH
Francois de l’Escaille, Analis s.a./n.v.
Christof Finkler, F.Hoffmann – La Roche Ltd.
Anders Lund, Genzyme, a Sanofi Company
Andras Guttman, Northeastern University
Birgit Schmauser, BfArM, Federal Institute for Drugs and Medical Devices
Harold Taylor, Merz Pharmaceuticlas GmbH
Audio-Visual:
Michael Johnstone, MJ Audio-Visual Productions
CASSS Staff:
Stephanie Flores, Executive Director
Renee Olson, Senior Program Manager
Anna Lingel, Project Coordinator
Catherine Stewart, Finance Manager
6
AT Europe 2015
Scientific Final Program Summary
Tuesday, 17 March, 2015
06:30 – 09:00
Buffet Breakfast in Restaurant Coelln
06:30 – 10:30
Buffet Breakfast in Restaurant Coelln (for accompanying guests)
08:30 – 14:00
Registration (for course attendees ONLY) in the TBD
09:00 – 17:00
Short Course in Drachenhaus Room
Reliable Methods in Capillary Electrophoresis: Fundamentals and Good Working Practice
Short Course Facilitators: François de l'Escaille, Analis s.a./n.v., Namur, Belgium
and Cari Sänger - van de Griend, Kantisto BV, Baarn, The Netherlands
09:00 – 17:00
Short Course in Wintergarten Room
Fundamentals of Mass Spectrometry
Short Course Facilitator: Anders Lund, Genzyme, a Sanofi Company, Framingham, MA USA
12:30 – 13:30
Hosted Lunch (for course attendees ONLY) in the Coelln Room
7
Wednesday, 18 March, 2015
08:30 – 18:00
Registration in the Club Diana
06:30 – 09:00
Buffet Breakfast in Restaurant Coelln
06:30 – 10:30
Buffet Breakfast in Restaurant Coelln (for accompanying guests)
09:00 – 09:05
CASSS Welcome and Introductory Comments in Salon Unter den
Linden/Friedrichstadt
Frantisek Svec, CASSS President, Emeryville, CA USA
09:05 – 09:15
Meeting Welcome and Introductory Comments in Salon Unter den
Linden/Friedrichstadt
Cari Sänger - van de Griend, Kantisto BV, Baarn, The Netherlands
Keynote I Session in Salon Unter den Linden/Friedrichstadt
Session Chair: Cari Sänger - van de Griend, Kantisto BV, Baarn, The Netherlands
09:15 – 10:15
Analytical Sciences in Biotechnology: Opportunities and Challenges
Wassim Nashabeh, F. Hoffmann – La Roche Ltd., Basel, Switzerland
10:15 – 10:45
Break – Visit the Exhibits and Posters the Salon Foyer
Interface Development and Quality Control Session in Salon Unter den Linden/Friedrichstadt
Session Chair: Harold Taylor, Merz Pharmaceuticals GmbH, Frankfurt Am Main, Germany
10:45 – 11:10
Charge Heterogeneity by CZE: A Test Method fit for QC Testing?
Marc Hassel, Novartis Pharma AG, Basel, Switzerland
11:10 – 11:35
But It Always Works for ME! R&D vs QC Methods for Biotech Products
Nadine Ritter, The Global Biotech Experts Collaborative, LLC, Germantown, MD
USA
11:35 – 12:00
The Regulatory Role of Mass Spectrometry for the Characterization of
Peptides, Proteins, and Monoclonal Antibodies
Michael Boyne, CDER, FDA, Silver Spring, MD USA (tentative)
12:00 – 12:30
Discussion
12:30 – 13:30
Buffet Lunch in Restaurant Coelln
13:30 – 14:30
Poster Session in Salon Foyer
8
Wednesday, 18 March, 2015
New Trends in Capillary Electrophoresis Session in Salon Unter den Linden/Friedrichstadt
Session Chair: François de l'Escaille, Analis s.a./n.v., Namur, Belgium
14:30 – 14:55
Development of High-throughput MCE Assays for Classical and Novel
Biotherapeutics
Friederike Winkhaus, Roche Diagnostics GmbH, Penzberg, Germany
14:55 – 15:20
Capillary Electrophoresis for the Quantification of Adenovirus Particles for
Process Development Support
Ewoud van Tricht, Crucell Holland BV, Leiden, The Netherlands
15:20 – 15:45
Application of Capillary Electrophoresis for the Standardization of
Measurements of Protein Biomarkers for In-Vitro Diagnostics
Guy Auclair, European Commission, Geel, Belgium
15:45 – 16:15
Discussion
16:15 – 17:15
Technical Seminar
TBD
Sponsored by SCIEX Separations
Salon Unter den Linden/Friedrichstadt
17:15 – 18:15
Workshop I: Roud Robin Tabletop Discussion in Salon Unter den Linden/Friedrichstadt
Session Chair: Hansjörg Toll, Sandoz GmbH, Kundl, Austria
18:15 – 19:15
Exhibition Reception – Visit the Salon Foyer
9
Thursday, 19 March, 2015
08:30 – 17:00
Registration in the Club Diana
06:30 – 09:00
Buffet Breakfast in Restaurant Coelln
06:30 – 10:30
Buffet Breakfast in Restaurant Coelln (for accompanying guests)
Method Development and QbD Session in Salon Unter den Linden/Friedrichstadt
Session Chair: Christof Finkler, F. Hoffmann – La Roche Ltd., Basel, Switzerland
09:00 – 09:25
TBD
Melissa Hanna-Brown, Pfizer, Inc., Sandwich, UK
09:25 – 09:50
Quality Aspects in the Research Laboratory - Method Development
Katalin Ganzler, Gedeon Richter Plc. Budapest, Hungary
09:50 – 10:15
TBD
Oliver Grosche, Novartis Pharma AG, Basel, Switzerland
10:15 – 10:45
Discussion
10:45 – 11:15
Break – Visit the Exhibits and Posters in Salon Foyer
Post Translational Modification’s Session in Salon Unter den Linden/Friedrichstadt
Session Chair: András Guttman, Northeastern University, Boston, MA USA
11:15 – 11:40
CE and UPLC: Complementary High-hand Tools to Tune N-glycosylation of
Therapeutic Proteins
Flavie Robert, Merck Serono, Corsier sur Vevey, Switzerland
11:40 – 12:05
In Depth Chracterization of Biotherapeutics by Mass Spectrometry - A Case
Study
Udo Roth, Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany
12:05 – 12:30
Emerging mass spectrometry based methods for therapeutic mAbs,
biosimilars and ADCs deep structural characterization
Elsa Wagner-Rousset, Centre d’Immunologie Pierre Fabre, Saint Julien en
Genevois, France
12:30 – 13:00
Discussion
13:00 – 14:15
Buffet Lunch in Restaurant Coelln
10
Thursday, 19 March, 2015
14:15 – 14:45
Technical Seminar
TBD
Sponsored by Genedata GmbH
Salon Unter den Linden/Friedrichstadt
New Trends in Mass Spectrometry Session in Salon Unter den Linden/Friedrichstadt
Session Chairs: Martin Blüggel, Protagen Protein Services GmbH, Dortmund, Germany
14:45 – 15:10
New approaches for PK profiling of glycol-variants to support criticality
assessment during early development
Andreas Seidl, Sandoz Biopharmaceuticals Oberhaching HEXAL AG,
Oberhaching, Germany
15:10 – 15:35
Top-down and Middle-up Hydrogen/deuterium Exchange Mass
Spectrometry for Accurate, Sensitive and Comprehensive Structural
Characterization of Biosimilars
Christoph Borchers, University of Victoria, Victoria, BC Canada
15:35 – 16:00
Proteomic Characterization of Harvest Cell Culture Fluid in Support of Host
Cell Protein Immunoassay Development
Christopher Yu, Genentech, a Member of the Roche Group, South San Francisco,
CA USA
16:00 – 16:25
Quantitative Protein Expression Determination for Biologics and Vaccines
by Mass Spectrometry
Arjen Scholten, Janssen Infectious Diseases and Vaccines Curcell Holland BV,
Leiden, The Netherlands
16:25 – 16:55
Discussion
16:55 – 17:10
Break - Visit the Exhibits and Posters in Salon Foyer
17:10 – 18:10
Technical Seminar
TBD
Sponsored by Bruker Daltonik
18:30 – 22:00
Salon Unter den Linden/Friedrichstadt
Conference Event – Location and more information coming soon.
11
Friday, 20 March, 2015
08:30 – 12:00
Registration in the Club Diana
06:30 – 09:00
Buffet Breakfast in Restaurant Coelln
06:30 – 10:30
Buffet Breakfast in Restaurant Coelln (for accompanying guests)
CE-MS Session in Salon Unter den Linden/Friedrichstadt
Session Chair: Cari Sänger - van de Griend, Kantisto BV, Baarn, The Netherlands
09:00 – 09:25
Simultaneous Determination of Protein Affinity and Heterogeneity by
Capillary Electrophoresis-mass spectrometry
Rob Haselberg, VU University, Amsterdam, The Netherlands
09:25 – 09:50
TBD
Göran Hübner, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der
Riss, Germany
09:50 – 10:15
TBD
Christian Neusüß, Aalen University, Aalen, Germany
10:15 – 10:45
Discussion
10:45 – 11:15
Break - Visit the Exhibits and Posters in Salon Foyer
Regulatory Session in Salon Unter den Linden/Friedrichstadt
Session Chair: Birgit Schmauser, BfArM, Federal Institute for Drugs and Medical Devices, Bonn,
Germany
11:15 – 11:40
Regulatory Perspectives on Advanced Analytical Methods used for
Characterization and Control of Biopharmaceutical Products
Sarah Kennett, CDER, FDA, Silver Spring, MD USA (tentative)
11:40 – 12:05
TBD
12:05 – 12:35
Discussion
12:35 – 12:40
Closing Comments in Salon Unter den Linden/Friedrichstadt
Hansjörg Toll, Sandoz GmbH, Kundl, Austria
12

Download Report