Advanced Analytics for Therapeutic Proteins: from Research to Manufacturing

Poster Programme

Topic: Protein drug lead identification

Development of an affinity HPLC analytical method for the quantification of IgM with monolithic columns
B. Gabor1, T. Baechle2, P. Kramberger1, T. Jakop1, M. Barut1, F. Hensel3, A. Štrancar1,
1BIA Separations d.o.o., Ajdovščina/SLO, 2 BIA Separations GmbH, Villach/A, 3Patrys GmbH Wuerzburg/D

Rapid antibody de novo sequencing by reference sequence matching
B. Gruenwalder, S. Klostermann, M. Hilger, Roche Diagnostics GmbH, Penzberg/D

Optimizing the enzymatic subunit generation with IdeS for high throughput structure
verification of therapeutic antibodies by middle-down MS
F. Olsson*, L. Andersson*, W. Jabs, A. Resemann, W. Evers, S. Pengelley, C. Baessmann, D. Suckau, *Genovis AB, Lund/S, Bruker Daltonik GmbH, Bremen/D

Applications of label-free assays in biopharmaceutical development
H. Wünsche, Pall GmbH, Dreieich/D

Characterization of conformational epitopes of therapeutic antibodies by bottem-up hydrogen-deuterium exchange mass spectrometry
B. Wang1, V. Larraillet1, C. Spick1, A. Imhof2, J. Regula1, A. Papadimitriou1, A. Zeck3, M. Hilger1,
Roche Diagnostics GmbH, Penzberg/D1, Munich University/D2, University of Tuebingen (NMI)/D3

Topic: Predictability and developability - increasing technical successs

Advanced analytical tools bettering biopharmaceuticals develeopment
A. Barbas1, F. Fernandes1,2, A. Teixeira1,2, M. Freitas1,2, T. Bandeiras1,2, G. Real1,2, P. Matias1,2, M. Carrondo1, P. Alves1,2, IBET, Oeiras/P1, ITQB-UNL, Oeiras/P2

DoE-based approaches for the prediction of upstream and downstream operations
in production processes for plant-derived biopharmaceuticals
J.F. Buyel, R. Fischer, RWTH Aachen University, Aachen/D

Automated small scale protein purification for bioanalytical characterization workflows
R. Sawkins, Perkin Elmer LAS, Cambridge/UK

Topic: Bioassays - molecules in action

Bioactivity testing of FSH: a new cell based assay for the replacement of the
Steelman-Pohley in vivo assay
C. Giese, C.D. Demmler, ProBioGen AG, Berlin/D

Evaluation of the typical NKL based ADCC vs. a commercially available reporter system
A. Puklowski, T. Wenger, A. Tolstrup, Boehringer Ingelheim GmbH & Co. KG, Biberach/D

Semi-automated ADCC potency assays for release testing
P. Schroeder, S. Mayer, M. Engel, C. Lindemann, EUFETS GmbH, Idar-Oberstein/D

Topic: Analysis of modifications and conjugates - ADCs, PEG and more

Hollow fiber field flow fractionation (HF5) increases sensitivity and efficiency in the separation of therapeutic antibodies and other complex protein samples
T. Jocks, C. Johann, Wyatt Technology Europe GmbH, Dernbach/D

Analytical characterization of post-translational modifications of monoclonal antibodies
S. Möcklinghoff, W. Schröder, K.-P. Gerbling, BHC Bayer Pharma AG, Wuppertal-Elberfeld/D

Topic: Analysis of byproducts

MS-quantification of hemoglobin in pharmaceutical preparations:
Comparison of different approaches

M. Müller, E. Reh, University of Applied Sciences Bingen/D

Topic: Analysis of biological contaminants

Development of immunoassay for the host cell proteins of Nicotiana species to be used in the biopharmaceutical development
Z. Ahmad Arfi1, 2, 3, R. Fischer1, 2, S. Hellwig2, J. Drossard2
RWTH Aachen University1, Fraunhofer Institute of Molecular Biotechnology and Applied Ecology2, BSV Biosciences GmbH3, Aachen/D

Low endotoxin recovery in Limulus based detection systems
J. Reich1,2, H. Grallert2, University Regensburg1, Hyglos GmbH, Bernried/D2

High sample throughput quantification of Chinese hamster ovary host cell protein (CHO-HCP) with electrochemiluminescence immunoassay (ECLIA)
M. Wiedmann, M. Leiss, O. Pester, M. Meier, R. Vogel, F. Wedekind, H. Wegele, Roche Diagnostics GmbH, Penzberg/D







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