Advanced Analytics for Therapeutic Proteins: from Research to Manufacturing

Lecture Programme

Wednesday, September 18, 2013

Lunch (optional)

Welcome Address
H. Kaufmann, Boehringer Ingelheim Pharma GmbH & CoKG, Biberach/D

The new quality paradigm
Chair: H. Kaufmann, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach/D

13:35   Keynote Lecture
Biosimilar, biobetter, and next generation antibody characterisation by mass spectrometry

A. Beck, Centre d'Immunologie Pierre Fabre (CIPF), St Julien-en-Genevois/F

High performance protein analytics as a key for successful biosimilar development
M. Blueggel, A. Schnabel, S. Mette, A. Wattenberg, Protagen AG, Dortmund/D

Binding- and cell-based bioactivity assays for biosimilar monoclonal antibodies
C. Giese, C.D. Demmler, ProBioGen AG, Berlin/D

Using powerful HT chromatography screenings to develop purification steps modulating
charge-related isoform patterns

F. Rudolph1, A. Gerster1, M. Pauers2, M. Hampel2, M. Dieterle1, Process Science-Protein Science1, -Analytics & Drug Delivery Support2, Boehringer Ingelheim Pharma GmbH & CoKG, Biberach/D

Coffee Break

New molecule formates

Chair: B. Müller-Tiemann, Bayer HealthCare AG, Wuppertal/D

16:00   Keynote Lecture
Considerations about physicochemical characterization of maytansinoid ADCs

A. Lazar, ImmunoGen, Inc., Waltham/USA

Characterisation and quantification of therapeutic antibodies and antibody-drug
conjugates using high resolution accurate mass spectrometry

S. Watt, A&M STABTEST GmbH, Bergheim/D

17:05   Keynote Lecture
Analytical characterization of antibody mixtures in process development and manufacturing
J. Wagtberg Sen, Symphogen A/S, Lyngby/DK

End of Lecture Programme of Day 1

Guided Tour Irsee Monastery


Get Together


Thursday, September 19, 2013

Speed and success - focus on developability
Chair: J. Studts, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach/D

09:00   Keynote Lecture
Engineering of antibodies for successful development
L. Linden, Bayer Healthcare, Wuppertal/D

Making therapeutic antibodies fit for pipeline
D. Weinfurtner, S. Pabst, B. Brocks, R. Ostendorp, MorphoSys AG, Martinsried/D

In-silico prediction of degradation hotspots in antibody variable regions
J. Sydow, Roche Diagnostics GmbH, Penzberg/D

Fourier transform mid infrared spectroscopy- a cost-effective tool for monitoring mAb titer and mAb aggregates in bioprocess samples
F. Capito1, C. Hunzinger2, R. Skudas2, B. Stanislawski2, H. Kolmar1, 1Technische Universität Darmstadt/D, 2Merck KGaA, Darmstadt/D

Coffee Break


High-throughput and high-performance analytics
Chair: R. Pörtner, Hamburg University of Technology/D

11:15   Keynote Lecture
High-performance glycoanalysis - combining MALDI-MS, CE-MS and xCGE-LIF
E. Rapp, Max Planck Institute for Dynamics of Complex Technical Systems / glyXera GmbH, Magdeburg/D

Charge variants analysis in monoclonal antibodies by capillary electrophoresis technologies compared to classical HPLC or gels techniques
V. Auquier, UCB Pharma sa, Braine-I'Alleud/B

Advanced charge isoform detection by high throughput micro-CZE
S. Pleiner, H. Geier, P. Dobberthien, J. Studts, Boehringer Ingelheim Pharma GmbH & CoKG, Biberach/D

Sheathless CE-MS in analysis of peptide and protein therapeutics
P.C. Gross1, S.C. Burkart1,3, H. Seelert1, R. Müller1,2,3, 1PharmBioTec GmbH, Saarbrücken/D, 2Helmholtz Centre for Infection Research, Saarland University, Saarbrücken/D, 3Dept. of Pharmaceutical Biotecnology, Saarland University, Saarbrücken/D



Bioassays - molecules in action
Chair: U. Bethke, Miltenyi Biotec GmbH, Bergisch-Gladbach/D

14:15   Keynote Lecture
In the aftermath of TNG1412: new preclinical approaches to assess mAb function
U. Kalinke, Hannover Medical School / TWINCORE GmbH,Hanover/D

Functional immortalized endothelial cell lines for development of bioassays
T. May1, R. Schucht1, J. Zauers1, D. Wirth2, 1InSCREENeX GmbH, Braunschweig/D, 2Helmholtz Centre for Infection Research, Braunschweig/D

Antibody potency testing in ADCC assays using effector cell lines expressing the high or low affinity variant of Fc gamma-receptor III
C. Lindemann, S. Mayer, M. Engel, P. Schroeder, EUFETS GmbH, Idar-Oberstein/D

SPR-Binding studies to predict in-vivo effector functions of therapeutic proteins
S. Müller, Boehringer Ingelheim Pharma & Co KG, Biberach/D

Coffee Break


Inpurities and contaminants
Chair: H. Tebbe, Roche Diagnostics Deutschland GmbH, Penzberg/D

16:30   Keynote Lecture
Leptospira licerasiae - a novel bacterial contamination in biopharmaceutical manufacturing
S. Deutschmann, Roche Diagnostics GmbH, Penzberg/D

UCB's strategy to tackle elemental impurities in a changing regulatory landscape
C.Chery, UCB Pharma sa, Braine-I'Alleud/B

End of Lecture Programme of Day 2

Poster Session / Section Member Assembly




Friday, September 20, 2013

Innovation in mass spectroscopy
Chair: A. Beck, Centre d'Immunologie Pierre Fabre (CIPF), St Julien-en-Genevois/F

09:00   Keynote Lecture
Mass spectrometry based proteomics in pre-clinical drug discovery
M. Schirle1, M. Bantscheff2, B. Kuster3, 1Novartis Institutes for BioMedical Research Inc, Cambridge, MA/USA, 2Cellzome - a GKS company, Heidelberg/D, 3Technische Universität München, Freising/D

Quantitative, antibody-free LC-MS/MS analysis of recombinant tumor necrosis factor-related apoptosis-inducing ligand (TRAIL) in serum
R. Bischoff, D. Wilffert, C.R. Reis, J. Hermans, H. Govorukhina, S. de Jong*, W.J. Quax, N.C. van de Merbel, University of Groningen/NL, * University Medical Center Groningen/NL


Manufacturing: QconCAT absolute quantification of host cell proteins and impurities and metabolic modeling of production strains
M. Fischer, PolyQuant GmbH, Bad Abbach/D

Routine mass spectrometry solutions for biosimilar development applied to Panitimumab and Cetuximab
W. Jabs1, A. Resemann1, W. Evers1, C. Evans1,  L. Main2, C. Baessmann, D. Suckau, E. Wagner-Rousset3, A. Beck4, 1Bruker Daltonik GmbH, Bremen/D, 2Bruker Daltonik GmbH, Fällanden/CH, 3Bruker Daltonics Ltd, Coventry/UK, 4Centre d'Immunologie Pierre Fabre (CIPF), St Julien-en-Genevois/F

Coffee Break


Omics technologies - promise and power
Chair: T. Noll, University of Bielefeld/D

11:15   Keynote Lecture
Genomics and other omics technologies of mammalian host cells
M. Betenbaugh, Johns Hopkins University, Baltimore/USA

Application of systems biotechnology tools for data driven biopharmaceutical process development
J. Bechmann, M.M. Mueller, C. Clemens, J. Schaub, H. Bradl, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach/D

Advanced Analitics for therapeutic proteins: an array of Si microbalances for quantitative proteomics
G. Scoles, University of Udine/I

End of Lecture Programme - Closing Remarks




Jetzt Mitglied werden