PEGS Europe

November 18–22, 2019
Lisbon, Portugal

Meet Genedata experts at PEGS Europe in Lisbon, Portugal.

Don't miss the opportunity to see how Genedata solutions efficiently support the whole biopharmaceutical R&D workflow, including screening and protein engineering, expression and purification, characterization and analysis of protein therapeutics, cell line design and development, bioprocess optimization, and quality control of biologicals.

To get more information about Genedata solutions, please contact info@genedata.com.

Recommended Oral Presentations

Industrializing IO Therapeutic Discovery Platforms: Multispecifics, Engineered TCRs and CAR Ts
Jana Hersch, Ph.D., Scientific Consultant, Biologics, Genedata

Engineering Antibodies Session
Wednesday, November 20 | 12:45–13:15

Novel classes of bio-molecules are currently evaluated for their use in cancer immunotherapy. Bi- and multi-specific antibodies, Ab-cytokine fusion proteins, non-Ig scaffolds, chimeric antigen receptors (CARs), engineered TCRs and TCR-based bispecific constructs promise significant advantages. However, these highly engineered molecules pose new challenges in design, engineering, cloning, expression, purification, and analytics. Genedata Biologics offers an infrastructure that addresses these challenges and enables the industrialization of these various novel therapeutic platforms.

Automated Multi Attribute Method Analyses for Process Development and Characterization of mAbs
Martin Hoffmann, Senior Scientist, Research & Development – Bioanalytics Frankfurt – Bioprocess Analytics, Sanofi-Aventis Deutschland GmbH

Analytical Characterization of Biotherapeutics Session
Wednesday, November 20 | 13:15–13:45

We present a mass spectrometry based approach to simultaneously monitor critical quality attributes (CQA) of therapeutic monoclonal antibodies (mAbs) - multi-attribute method (MAM). With MAM we are supporting the process development of mAbs. For CQA quantification, mAbs samples were digested on an automated liquid handling robot and analyzed by HPLC separation in combination with high resolution mass spectrometric detection. Focus of the presentation will be the automated data analysis with the Genedata Expressionist software.

A Reliable and Automated Workflow for LC-MS MAM Analysis of Biopharmaceuticals – From High Throughput Sample Preparation to Data Evaluation
Patrick Sascha Merkle, Ph.D., Analytical Development & Characterization, Novartis Pharma AG

Analytical Characterization of Biotherapeutics Session
Wednesday, November 20 | 17:15–17:45

The LC-MS multi-attribute method (MAM) has emerged as a promising approach for the characterization and relative quantification of critical quality attributes on biopharmaceutical molecules. Here, we present our peptide-level LC-MS MAM workflow that relies on high-throughput sample preparation, high-resolution MS acquisition, and automated data evaluation in the Genedata Refiner MS software. We envisage that the simplicity and state of automation of the presented LC-MS MAM workflow may allow its routine use in a non-expert laboratory.

A Platform Approach to Manage Developability and Manufacturability Risks of Biologics Molecules
Sebastian Kolinko,
Ph.D., Scientific Consultant, Biologics, Genedata

Characterization of Biotherapeutics and Biophysical Characterization of Biotherapeutics Session
Thursday, November 21 | 10:05–10:35

We present a workflow system that enables systematic developability and manufacturability assessments, using both in silico and high throughput analytical confirmatory methods, over the entire biologics R&D process from initial discovery all the way to final candidate selection. We show use cases for mAbs and other complex multi/bispecific formats and discuss building predictive developability models utilizing this system. We also present the underlying molecule and task management needed for analytical organizations to accomplish this.

Recommended Poster Presentations

Session A (Monday‒Tuesday)

A Platform Approach to Manage Developability and Manufacturability Risks of Biologics Molecules

Employing the MS-based Multi-attribute Method (MAM) for Automated Quality Monitoring of Biotherapeutics

A New Enterprise Software Platform for Efficient Large-Scale Antibody Characterization and Epitope Binning

Session B (Wednesday‒Thursday)

Industrializing Immuno-Oncology Therapeutic Discovery Platforms

End-to-End Workflow Platform for Integrated Biopharmaceutical Development

Efficient Data Processing Workflows for in-depth, MS-based Glycoanalysis of Biopharmaceuticals

Automated Comprehensive Characterization and Quantification of Low-abundance Sequence Variants in a Standard Monoclonal Antibody

Links:
www.pegsummiteurope.com