The Analytical Characterisation of Biotherapeutics at PEGS Europe brings analytical scientists together to share their knowledge and experiences in developing new approaches to characterize molecules and residual impurities; while expanding their toolbox to include exciting technologies such as ARMES, aptamers, native MS and MAM, etc.

Preliminary Agenda

STANDARDS AND REGULATORY CONSIDERATIONS FOR ADVANCED THERAPEUTICS

KEYNOTE PRESENTATION: An International Collaboration: Towards the Standardisation of Gene Therapy

Yuan Zhao, PhD, Principal Scientist, Leader, Gene Therapy Section, Advanced Therapy Division, NIBSC, Medicines & Healthcare Products Regulatory Agency

USP Standards and Best Practices for Advanced Therapies

Fouad Atouf, PhD, Vice President, Global Biologics, U.S. Pharmacopeia

NEW TOOLS AND APPROACHES

Anisotropy Resolved Multi-Dimensional Emission Spectroscopy (ARMES): A Multivariate Approach to Intrinsic Protein Emission Analysis

Alan G. Ryder, PhD, Professor, Nanoscale Biophotonics Laboratory, National University of Ireland Galway

Aptamers and Enzyme Cascades as New Tools for Analytical Characterization of Biopharmaceuticals

Urs Lohrig, PhD, Lab Head, Physico-Chemical Characterisation, Novartis

Kinetic Mechanism of Controlled Fab-Arm Exchange for the Formation of Bispecific Immunoglobulin G1 Antibodies

Mark Chiu, PhD, Associate Director, Process Analytical Sciences, Janssen R&D

Potent Bispecifics, Overcoming Analytical Challenges Enroute Preparation for FIH

Sachin Dubey, PhD, Deputy Director/Head, Formulation, Analytical and Drug Production Development, Glenmark Pharmaceuticals SA

Luncheon Presentation: Industrializing IO Therapeutic Discovery Platforms: Multispecifics, Engineered TCRs and CARs

Christoph Freiberg, PhD, Senior Scientific Consultant, Biologics, Genedata

Bispecific Binding Kinetics Analysed with a Two-Colour switchSENSE® Biosensor

Ulrich Rant, PhD, CEO, Dynamic Biosensors GmbH

MASS SPEC AND MULTI-ATTRIBUTE METHODS (MAM)

The Transition to Native MS in a Biopharmaceutical Development Lab – Lessons Learned and the Road Ahead

Dan Bach Kristensen, PhD, Principal Scientist, Symphogen

Probing Biopharmaceutical Microheterogeneity Using Native LC-MS

Jonathan Bones, PhD, Principal Investigator, CCL, National Institute for Bioprocessing Research and Training

A Reliable and Automated Workflow for LC-MS MAM Analysis of Biopharmaceuticals – From High Throughput Sample Preparation to Data Evaluation

Patrick Sascha Merkle, PhD, Postdoc, Analytical Development & Characterization, Novartis Pharma AG

HOST CELL PROTEIN ANALYSIS

Quantitation of HCP by Mass Spectrometry as a Method to Control the Quality of Biopharmaceuticals

Annick Gervais, PhD, Director, Analytical Development, Biologicals, UCB

Monitoring of Clearance of Lipase Host Cell Proteins in mAb Manufacturing Using a LC-MRM Quantitation Method

Rachel Chen, PhD, Scientist II, Analytical Development, Biogen



* The program is subject to change without notice, due to unforeseen reason.

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