23rd JUNE 13.40 - 13.10

Manipulation of Chromatographic Formats to Improve Sensitivity and Simplify Workflows for MS Applications
Diego Rodriguez Cabaleiro, DMPK Marketing Manager, Waters Corporation

One of the most challenging goals facing modern bioanalytical (DMPK) laboratories is developing LC/MS/MS assays with the required level of sensitivity. In this seminar we will demonstrate how LC system improvements can provide higher sensitivity and lower limits of detection in challenging bioanalytical assays. Our latest development, the ionKey system solution will be presented in detail.
UPC² technology and its application in the DMPK laboratory will be also presented. UPC² is a separation technique that provides unique benefits in selectivity and workflow when compared to traditional reversed- or normal-phase liquid chromatography, using carbon dioxide as the primary mobile phase. This approach reduces time in sample preparation and analysis, allows direct injection of samples without dilution or evaporation and aids in resolution of analytes of interest with minimal method development time. In addition this is a technique that can be used to quickly and easily separate chiral compounds and is renowned for its reliability, robustness, and sensitivity.

24th JUNE 17.00 - 17.30

Optimise Your Strategy to Ensure Robust LC Methods Development
Stephanie N. Harden, Small Molecule Pharmaceutical Business Development Manager, Waters Corporation
Marleen van Wingerden, Biopharmaceutical Market & Separation Technologies Business Development Manager, Waters Corporation

During this session, we shall demonstrate how the implementation of a streamlined approach to method development, in conjunction with the employment of QbD in the method development process, can save time, provide robust methods and help ensure product quality. Our approach combines a systematic screening protocol, involving combinations of column chemistry, organic modifier and mobile phase pH, together with the sub 2µm particle technology and quaternary solvent mixing capability of the ACQUITY UPLC H-Class system, and the novel QDa mass detector. The combination of UV and mass spectral information with this systematic approach ensures the development of methods that are more information-rich and significantly faster, improving the overall profitability of the assay.

June 24 - 13:00 - 13:30

Biopharma solutions using the Q Exactive platform
Kai Scheffler, Thermo Fisher Scientific, Dreieich, Germany

Biopharmaceuticals are in most cases challenging molecules that require a variety of different techniques to perform full characterization including all qualitative and quantitative aspects and the analysis of modifications on the protein and peptide level. The analysis of intact proteins and especially large proteins such as intact antibodies and protein complexes on the Orbitrap platform have steadily advanced on a technical level ever since the Orbitrap mass analyzer became commercially available in the year 2005, only been made possible due to several technological advancements we implemented in newer generations instruments. One of the newer generation instrument platforms is the Q Exactive benchtop OrbitrapTM mass spectrometer, an instrument we introduced into the market in the year2011.
This workshop presentation is focused on qualitative and quantitative LC-MS workflows applicable to the Q Exactive platform aiming at the full characterization of biopharmaceuticals. During the course of the presentation hardware and software details are highlighted with a strong focus on workflows and application data.

June 25 - 13:00 - 13:30

This seminar will cover the solutions available from AB SCIEX in the analysis of the next generation of biopharmaceuticals. 
It will look at the potential of the capillary electrospray ionization (CESI 8000 system) coupled to mass spectrometry and show how it can be used to provide full sequence coverage of monoclonal antibodies with the additional detection of post translation modification (PTMs) and the mapping of glycosylation  sites all in one analysis at ultra-low flow rates. 

In addition, real examples where the TripleTOF® 5600 system has already provided solutions for Host Cell Protein (HCP) Analysis, disulfide bond position mapping and other product quality attributes, which are essential to determine in antibody production, will be discussed.

Finally the session will conclude with some comments on where the combination of these two technologies can take us in the future, in the areas of native MS and antibody drug conjugates analysis.