Analytical scientists are facing a daunting challenge. Multitudes of new modalities and non-platform formats are landing in their labs, requiring the analytical scientists to develop robust methods to characterise these molecules, and to meet regulators’ demands for more complex data reporting.
The 6th Annual Analytical Characterisation of Biotherapeutics at PEGS Europe strives to bring analytical scientists together to share their knowledge and expertise in characterizing the structure-function, glycosylation, and higher order structure of these complex molecules; while enhancing their toolbox with exciting technologies such as microfluidics, aptamers, cyro-EM microscopy, MAM, Native-MS, and coupling MS with LC, IEX, SEC, HDX etc.
Coverage will include, but is not limited to:
- Characterizing Complex Modalities – Bispecifics, Multispecifics, Cell- and Gene-Based Therapies, Virus-Like Particles, Fusions, Mixtures etc.
- Method development, validation and transfer
- Method bridging and lifecycle management
- Determining structure-function relationship
- Glycan analysis
- Higher order structure analysis
- Demonstrating analytical similarity for next-generation biosimilars
- Native MS Techniques
- Insights into protein complexes in biological state for intact proteins, non-covalent proteins and protein-ligand complexes
- How to use native MS in development and QC?
- Coupling MS with microfluidics, LC, IEX, SEC, HDX and other techniques
- Multi-Attribute Methods
- MAM in QC environment
- Difference between peptide mapping assays and MAM assays
- Regulators’ opinions on submissions with MAM assays/data
- Challenges in standardization between labs
- How to choose a column? What solvents to choose? How does that impact your results?
- Novel Technologies and Approaches for Structural Elucidation and Stability Assessment
- Cyro-electron microscopy
- Aptamers for method development
- Automation in Analytics
- How do you process and report the data?
- Automatic data Processing and reporting
* The program is subject to change without notice, due to unforeseen reason.