Short courses and workshops

 

Short course 1: Facing the complexity of biopharmaceuticals characterisation - by Davy Guillarme and Yannis François

Protein biopharmaceuticals are macromolecules with a therapeutic effect, which are now more and more commonly used for the treatment of various diseases including cancer, diabetes, infection, inflammatory, and autoimmune disorders. However, protein biopharmaceuticals have a complexity far exceeding that of small molecule drugs. The goal of this short course is to introduce the general concepts about therapeutic proteins and provide some useful information on the analytical platforms that have to be used for their characterization. Among them, liquid chromatography (i.e. ion exchange, size exclusion, hydrophobic interaction, hydrophilic interaction, and reversed phase liquid chromatography) as well as capillary electrophoresis (i.e. capillary zone electrophoresis, gel capillary electrophoresis, capillary isoelectic focusing), coupled or not with mass spectrometry will be largely covered. Numerous applications to monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs) will be used to illustrate the advantages and limitations of these diverse analytical approaches.

This workshop will be suited for beginners in the field of protein biopharmaceuticals characterization, but with a good theoretical knowledge of liquid chromatography, capillary electrophoresis and their hyphenation to mass spectrometry. The workshop will also cover a number of advanced analytical approaches, which can also be of interest for more experienced users in proteins analysis.

 

 

Short course 2: Introduction to metabolomics workflow - by Coral Barbas and Serge Rudaz

The untargeted analysis of all the metabolites that change under a pathophysiological situation, or any wanted or unwanted action produced on a biological system, requires specific tools. In this short course, we will introduce the general concept of Metabolomics and it’s workflow. The main analytical platforms that are used, based on mass spectrometry will be presented, together with an introduction to the multivariate data analysis as well as Identification strategy of the instrumental signals to transform them into a name with a biological interpretation.

This short course will be suited for anyone interested in starting, improving or tailoring metabolomics workflows. Although a previous background on metabolomics is desirable, the workshop will cover the principles of each step on the workflow. During the workshop you will also have the opportunity to dicsuss advanced topics and specific refinements with the presenters.

 

 

Short course 3: From Validation to Uncertainty: Taking the Best from Regulations in Bioanalysis - by Jean-Marc Roussel

Although the EMA (2012), FDA (2018) and ICH M10 (Draft-2019) guidelines on Bioanalytical Methods Validation give clear statements on the validation design and methodology, the emergence of the Analytical Quality by Design (AQbD) and Target Measurement Uncertainty (TMU) concepts may confuse the analysts when coming to their bioanalytical methods validation stage. In this short-course we will describe the AQbD principles and explain how the EMA and FDA requirements can be included in this method development and lifecycle assessment workflow. We will particularly focus on the Accuracy characteristic and demonstrate how a simultaneous assessment of Precision and Trueness can provide the analyst with the Accuracy information, by means of the Total Error concept. Measurement Uncertainty is nowadays becoming a major concern in analytical and bioanalytical methods development, we will explain how this information can be extracted from the method validation results, using a balanced validation design such as those described in the EMA and FDA guidelines. We will also discuss about the use of this information in routine analysis and its role in decision making once the analytical result is obtained.

This short-course will be suited for all anyone involved in bioanalytical methods development and validation. Although a previous knowledge on basic statistics is desirable, the short-course will cover the principles of each calculation involved in the process. During this short-course, you will also have the opportunity to discuss specific refinements with the presenter.

 

Workshop: How to build an open-source capillary electrophoresis? - by Olivier Vorlet and Samuel Roth

In this 3h-workshop, a new generation open-source CE will be presented. This prototype, intended to be evolutionary and sustainable, was created by the University of Applied Sciences of Fribourg (Western Switzerland) in collaboration with the University of Geneva (Switzerland) and the Geneva University Hospitals (Switzerland). This CE device was conceived to help developing countries to fight falsified or sub-standard medicines, but it could also be useful for educational purposes. Interested users will get acquainted with the instrument, understand it and get trained on how to repair it. The new prototype includes a renewable energy source to make it independent from local supply, and an integrated software to simplify data treatment and reporting. Components are stardard and interchangeable, so they could be replaced by a local solution or easily available parts found on the Internet.

This workshop will be followed, during the whole symposium, by the complete assembly of the open source CE by two engineers of the University of Applied Sciences of Fribourg (Western Switzerland). A dedicated place in the exhibition area will be used to build this device from scratch. A video recording will be done during the process and a final demonstration will be performed at the end of the Symposium.