Short Courses Schedule:
Monday, September 9th
Morning schedule: 09h00 – 12h00
Afternoon schedule: 13h00 – 16h00
Lunches are included for the full day short courses participants, as well as for participants registering for a morning AND an afternoon short course.
Half-Day Short Courses
Morning
SC1 – Digital Evolution in Liquid Chromatography: Redefining Learning and Method Development with Virtual Tools – Davy Guillarme & Szabolcs Fekete
SC3 – The role of chromatography and mass spectrometry in protein biopharmaceutical analysis – Koen Sandra
Afternoon
SC4 – Analytical and computational tools for metabolite annotation by HPLC-MS – Gaétan Glauser & Emmanuel Defossez
SC5 – Analytical characterization of therapeutic oligonucleotides – Marianne Fillet
SC6 – Multiomics Data Analysis and Integration – Julien Boccard
Full Day Short Courses
SC7 – The analytical procedure lifecycle in accordance with ICH Q14 and ICH Q2: A deeper understanding of method performance to ensure continuous improvement and regulatory flexibility – Jean-Marc Roussel, Katrin Liebelt, Luis Ortiz
Morning
SC1 - Digital Evolution in Liquid Chromatography: Redefining Learning and Method Development with Virtual Tools
Davy GUILLARME, School of pharmaceutical Sciences, University of Geneva, Switzerland
Szabolcs FEKETE, Waters corporation, Geneva, Switzerland
This short course will be divided in two distinct parts, one for teaching and the other one for research.
The first part will be devoted to the presentation of freely accessible liquid chromatography simulation tools that can be used for theoretical and/or practical training of university students or internships wishing to learn the basic principles of chromatography. The trainers will give a particular focus on Excel tools developed at the University of Geneva and will demonstrate their possibilities using several case studies.
The second part of the short course will focus on the presentation of commercial modeling software for the automated development of liquid chromatography methods in the laboratory (Drylab, Fusion QbD, ChromSword…). The principle of operation of these software packages will be explained as well as the limitations/constraints associated with their use. The trainers will then focus on the Drylab software, which is probably the most widely used today. Several case studies will illustrate the possibilities offered by this software for the analysis of both small and large molecules.
SC3 - The role of chromatography and mass spectrometry in protein biopharmaceutical analysis
Koen SANDRA, RIC group, Belgium
Protein biopharmaceuticals are on the rise! These recombinantly produced therapeutic macromolecules currently account for 20% of the total pharmaceutical market and today monoclonal antibodies are considered the fastest growing class of therapeutics. Their success is driven by their efficacy in disease areas with a high unmet medical need such as oncology, autoimmune and infectious diseases.
From a structural point of view, protein biopharmaceuticals come with a complexity highly demanding towards analytics. Unraveling this structural complexity demands for a wide range of complementary analytical tools and methodologies with chromatography and mass spectrometry at the forefront.
In this short course, an overview will be provided of the different chromatographic and mass spectrometric approaches applied in biopharmaceutical analysis. Emerging trends such as multidimensional chromatography and native mass spectrometry will furthermore be touched upon. All this will be illustrated with real life examples from the presenter’s laboratory.
Afternoon
SC4 - Analytical and computational tools for metabolite annotation by HPLC-MS
Gaétan GLAUSER, Neuchâtel Platform of Analytical Chemistry, University of Neuchâtel, Switzerland
Emmanuel DEFOSSEZ, Institute of Biology, University of Neuchâtel, Switzerland
This short course intends to give the participants an overview of the different tools available for small molecule identification in the context of HPLC-MS metabolomics approaches.
The course will cover the basic concepts of mass spectral interpretation, the various MS acquisition modes used in metabolomics, and the latest advances in computational resources for metabolite annotation (molecular networks, in-silico annotation etc.).
SC5 - Analytical characterization of therapeutic oligonucleotides
Marianne FILLET, Full Professor, University of Liège, Belgium
The great potential of therapeutic oligonucleotides to treat a wide range of diseases has drawn more and more attention. To date, the USA Food and Drug Administration (FDA) have approved 16 oligonucleotide-drug treatments, twelve of these since 2016.
Due to their particular structure, their numerous potential impurities, and the regulatory framework governing their use as therapeutic agents, oligonucleotides require the implementation of appropriate analytical methodologies to provide a complete analysis of these biological molecules.
This workshop focuses on strategies and the latest developments in analytical methodologies applied to the characterization of therapeutic oligonucleotides. The first part of this workshop will be devoted to an introduction to the problems related to the specific analysis of these molecules and a presentation of the various separative methods used to characterize therapeutic oligonucleotides. The second part of the workshop will focus on analytical methods for the detailed assessment of these molecules.
SC6 - Multiomics Data Analysis and Integration
Julien BOCCARD, School of Pharmaceutical Sciences, University of Geneva, Switzerland
With the development of analytical techniques, it is now possible to generate large amounts of data for the characterization of complex samples. In addition, the emergence of approaches that combine multiple sources of information of different types is opening up new opportunities to better understand the mechanisms involved in biochemical processes. A major challenge is therefore to integrate the different blocks of data, and this is particularly true for Omics approaches (transcriptomics, metabolomics, lipidomics, proteomics), which have specific characteristics and require adapted statistical tools.
The aim of this workshop is to provide an overview of multisource Omics data structures and different supervised and unsupervised statistical approaches available for an integrative analysis. The first part will be devoted to multivariate methods (PCA and PLS) for analyzing high-dimensional data, while the second part will introduce multiblock approaches for integrating Omics datasets. The principles and practical aspects of the different methods will be presented and discussed.
Full Day
SC7 - The analytical procedure lifecycle in accordance with ICH Q14 and ICH Q2: A deeper understanding of method performance to ensure continuous improvement and regulatory flexibility
Jean-Marc ROUSSEL, Independent Consultant (Mâcon, France)
Katrin Liebelt (Novartis, Basel, Switzerland)
Luis Ortiz (Novartis, Basel, Switzerland)
ICH Q14 (Analytical Procedure Development) and Q2(R2) (Validation of Analytical Procedures) guidelines, which will become effective in June 2024, are ushering in a new era in the concepts of Analytical Quality by Design and Analytical Procedure Lifecycle Management (i.e., definition of the analytical target profile, systematic method development, method performance qualification including validation and transfer, and ongoing method performance verification).
During this course, we will review the general concepts of method development and additional elements of the analytical procedure lifecycle as described in the ICH Q14 guideline and USP chapter <1220>, respectively.
We will discuss the assessment of analytical methods performance according to ICH Q14 and ICH Q2, and address the question: “Is it a statistical nightmare or a walk in the park?”
Using application examples, we will focus on the robustness, validation, and performance monitoring of analytical procedures.
We will show the interest of Designs of Experiments (DoE) in the study of robustness and propose a methodology to evaluate the stability of the quantitative response in the Method Operable Design Region (MODR).
Next, we will explore the analysis of the response function, whether linear or non-linear, and discuss statistical tools for evaluating its performance.
Evaluating the accuracy and precision of analytical procedures remains a delicate issue, and we will show the value of using prediction or tolerance intervals to estimate procedure performance in routine use.
The concept of ongoing performance verification of analytical procedures will be introduced, along the value of control charts in this task.
Industrial case studies for systematic method development and enhanced method performance qualification approaches will be presented:
- on development pathways for platform/generic methods for biological products,
- strategies for combined validation and transfer studies aimed at assessing the overall variability of the analytical procedure, which consider additional noise factors between participating laboratories (i.e.: knowledge, experience, and equipment), applicable to small and large molecules.
It will be shown how these systematic and enhanced approaches enable the user to develop a comprehensive understanding of the sources of procedural variability and thus develop an appropriate analytical procedure control strategy.
Finally, to holistically implement these advanced approaches, we will present these method development concepts in the context of a patient-centered approach and a risk-based control strategy. Deepening the link between the quality attributes of a product and an analytical method, via its performance requirements, which is highly relevant to minimizing the risks of future changes and impact on the overall product control strategy.