During the course solventless sampling/sample preparation method, solid phase microextraction (SPME) will be discussed. This course will cover the main principles of the technique, calibration methods, coupling strategies of SPME to GC, LC, CE and MS, method development strategy, as well as advantages and disadvantages of the technique. Applications of the technologies in the fields such as forensic, pharmaceutical and clinical analysis will be discussed. Advances in the methods will be highlighted including: ligand-receptor binding and plasma protein binding studies, breath and skin analysis, in vivo sampling of freely moving animals for pharmacokinetic and metabolomic studies, automation in high-throughput format, direct tissue analysis with particular focus on intraoperative monitoring of drugs and biomarkers.
A2 - Bioinformatics and Statistical Methods for Metabolomics,
presented by: David Wishart, University of Alberta
The workshop will cover many topics ranging from understanding metabolomics technologies, data collection and analysis, using pathway databases, performing pathway analysis, conducting univariate and multivariate statistics, working with metabolomic databases and exploring chemical databases. Participants will be given various data sets and short assignments to assist with the learning process.
B1 - Quality by Design for Analytical Method Development,
presented by: Cari Sanger, Kantisto BV
QbD is a scientific, risk-based, holistic and proactive approach originally defined for product development. QbD works with predefined objectives and emphasizes product and process understanding and process control. In short, QbD is based on sound science and quality risk management. This is just as valid for analytical method development and AQbB has been adapted for several years in the (bio)pharma industry. The course will cover the main aspects of AQbD and explain the QbD language. Several examples will be shown and we will discuss how to make sure that we are developing reliable, efficient, and robust cost-saving methods to ensure that quality and patient safety standards are met.
B2 - New Advances in Biologics/Biopharmaceutical Characterization using CE and CE-MS,
presented by: G.W. Somsen, R. Haselberg, Vrije Universiteit - Amsterdam
CE has gained widespread interest in the analysis of protein-based therapeutics. Today, CE-SDS, CIEF and CE-LIF are routinely used for assessing the size, charge and glycan heterogeneity of protein pharmaceuticals. This course will start by treating the main aspects of these established CE techniques, and then focus on key areas where CE and CE‒MS can further enhance the characterization of biologics and biosimilars. Attention will be paid to capillary coating, MS interfacing and practical conditions used for intact protein analysis. The capability of CZE and CZE‒MS to probe modifications, such as deamidation, acetylation, lysine clipping, glycation and pyroglutamate formation, will be discussed. The potential of CE(‒MS) for biopharmaceutical characterization will be outlined by examples covering glycosylated biopharmaceuticals, monoclonal antibodies, antibody-drug conjugates (ADCs) and vaccine formulations.