- 分析性表徵分析 -
Analytical scientists have their work cut out for them. Multitudes of new, non-platform formats are landing in their labs, requiring them to develop robust methods to characterise these molecules, from which to identify the desired properties and target product profiles.
PEGS Europe’s 5th Annual Analytical Characterisation of Biotherapeutics aims to arm scientists with the tools and knowledge to speed innovation, by showcasing novel technologies, proven techniques or risk-based approaches that can help characterise the new modalities, analyse the structure-function and determine CQAs of the molecules.
CHARACTERISING NEW MODALITIES
KEYNOTE PRESENTATION: Integrating Analytical Strategies into a Comprehensive Development Strategy
Thomas Spitznagel, PhD, Senior Vice President, Biopharmaceutical Development & Manufacturing, MacroGenics
Cutting-Edge Analytical and Structural Methods for the Characterization of Antibodies and Antibody-Drug Conjugates
Elsa Wagner-Rousset, PhD, Senior Scientist, NBEs, Analytical Chemistry, Centre d’Immunologie Pierre Fabre
Identification and Quantitation of Duobody® Bispecific IgG1 Using Mass Spectrometry and Automated Data Processing and Analysis Workflow
Ewald van den Bremer, PhD, Senior Scientist, Analytical Sciences, Genmab B.V.
Product and Process Characterisation of Novel High-Potency Neurotoxin Therapeutics
David Spencer, MSc, Characterization Manager, Ipsen
Structure-Function Characterization of Sulfated Glycans in Recombinant Idursulfase
Bernice Yeung, PhD, Global Head of Characterization, Analytical Development, Shire
HOS in QC Environment - Could Native Peptide Mapping Support/Replace Bioassay for Stability Monitoring of Biopharmaceuticals?
Annick Gervais, PhD, Director, Physico-Chemical Method Development, Analytical Sciences Biologicals, UCB
Linking Analytical Measurements and Product Quality Attributes to Clinical Relevance
Viv Lindo, PhD, Associate Director, Product Characterization, MedImmune Ltd.
NOVEL METHODS AND NEW APPLICATIONS
A New Application of Multi Angle Light Scattering Coupled to Ion Exchange Chromatography (IEX-MALS) for Protein Characterization
Mario Lebendiker, PhD, Head, Protein Purification Facility, Wolfson Centre for Applied Structural Biology, Hebrew University of Jerusalem
Multi Attribute Method and Native Intact Mass Spectrometry for Characterization of Quality Attributes during Pharmaceutical Development of mAb Mixtures
Dan Bach Kristensen, PhD, Principal Scientist, Analytical Development, Symphogen A/S
Characterization of Variants of a Clinical Antibody Candidate Using Alternative and Novel Separation Methods
David Eisen, PhD, Scientist, Technical R&D, Technical Development Biosimilars, Novartis
Highly Glycosylated Therapeutic Proteins Neorecormon® and Mircera®: Novel Methods for Sample Generation, Structural and Functional Characterization
Alexander Buettner, PhD, Scientist, Analytical Development and Quality Control, Pharma Technical Development Europe, Roche Diagnostics GmbH