Bioanalysis Zone

AAPS 2016 ThermoFisher Scientific Vendor Seminars


Thermo Fisher Scientific Vendor Seminars

Tuesday, November 15th

Colorado Convention Center Room #2

Register to attend our vendor seminars and learn more about how our products and solutions can help make your discovery and development workflows faster and more efficient in nearly every phase of the process.


9:00 a.m.Ion Chromatography for Pharmaceutical Analysis

Jeff Rohrer, Thermo Fisher Scientific


Ion chromatography (IC) is a well-established liquid chromatographic technique increasingly being used for pharmaceutical analysis. IC typically uses an ion-exchange separation followed by suppressed conductivity, pulsed amperometry, or UV absorbance detection. Applications of IC in the pharmaceutical industry include drug assay, assay of one or more impurities in a drug substance, counterion determination, and measurement of drug product excipients. IC is one of the instrumental techniques now allowed by the USP for identification tests (USP <191>) and is also the prescribed technique for determining citrate and phosphate in drug products (USP <345>). In addition to its increased use in regulatory methods, modern IC has features valued by analytical laboratories.  For most applications the IC instrument is able to make its own mobile phase. The analyst must only add deionized water to the instrument.  This eliminates mobile phase preparation errors and improves intra- and inter-lab reproducibility. IC mobile phases rarely contain organic solvents and therefore waste disposal costs are reduced and the analyst is not exposed to sometimes hazardous organic solvents.


This workshop will cover the basic principles of IC including a detailed description of separation and detection options. The second section will review some representative IC applications for pharmaceutical analysis. The final portion of the workshop will describe the necessary steps for developing an IC application for pharmaceutical analysis.


9:30 a.m.Preparing Your Lab for USP Chapters 232 and 233

Fergus Keenan, Thermo Fisher Scientific


The United States Pharmacopeia (USP) will soon be implementing changes regarding the determination of elemental impurities in drug products sold in the United States.  The new guidelines will be a significant change from the current ones, affecting both the maximum allowable limits for elemental impurities, as well as the method for quantifying them.  Elemental analysis can be performed with a variety of techniques; however, careful decisions need to be made with regard to the specific budget and instrument performance needs (detection limits, speed of analysis, linear dynamic range) prior to purchasing an instrument.  Come see an overview of the new guidelines and learn useful tips for making sure your laboratory is compliant and prepared for the changes to come.


10:00 a.m.Intermediate Impurity Profiling – GC/MS Analysis of Pharmaceutical Intermediates


Simon Cubbon, Thermo Fisher Scientific

When it comes to pharmaceutical impurity analysis, there are many challenges. Impurity analysis is all about risk. Impurities will always exist, but it is the overall risk that they present that is important; that risk is a factor of the analyte toxicity and concentration. We will discuss how to overcome the challenges encountered in pharmaceutical intermediate impurity analysis, and how to deliver a new degree of confidence in the identification of unknown volatile and semi-volatile impurities.


We will present work performed in collaboration with pharmaceutical company AstraZeneca, who used our latest GC-MS technology for profiling of API intermediate impurities, showing examples of real-world use and results.


10:30 a.m.mAb MSIA Multiplexing: the simultaneous bioanalysis of Infliximab and Adalimumab

Eric Niederkofler, Thermo Fisher Scientific


Monoclonal antibodies (mAbs) and their derivatives, including antibody drug conjugates (ADCs), Single Domain Antibodies, Fragment Antibodies, etc., are increasingly becoming the preferred drug over the traditional small molecule regimens. These biologics possess improved efficacy, selectivity and decreased side effects. The bioanalysis of mAbs and their derivatives present many challenges for traditional Ligand Binding Assays (LBAs), particularly when their inherent heterogeneity and catabolic changes must be measured. Hybrid Ligand Binding (LB) LC-MS approaches are being increasingly utilized to address the challenges associated with bioanalysis of these large molecules as they continue to demonstrate the ability to overcome the shortcomings of utilizing LBA and LC-MS alone.  As the number of mAbs and their derivatives, and in particular their biosimilars, become more common there is a growing need for generic methodologies based on hybrid LB LC-MS to be developed.  Furthermore, it may become increasingly important for these methodologies to allow for the simultaneous measurement of multiple drugs in single analysis.  Presented will be the results of the development of such a generic methodology based on hybrid LB LC-MS capable of the simultaneous measurement of adalimumab and infliximab, both TNF inhibiting mAb therapeutics.

11:00 a.m.Using the Thermo Scientific™ Vanquish™ UHPLC to Compare the Protein Conformation in Solutions Before and After Crystallization using Althea’s Proprietary Crystalomics® Platform

Kevin McCowan, Ajinomoto Althea, Inc.


In this work we describe the use of second derivative UV data to assess tertiary structure of proteins pre and post formulation with Althea’s proprietary Crystalomics® technology. Crystalomics® enables the formulation of proteins in high concentration packages, minimizing volume and viscosity for improved patient use and acceptance.


Analysis of proteins on-line by size exclusion HPLC separation and detection by diode array allows for rapid and simultaneous determination of protein conformation and aggregation state. Shifts in key areas of the absorbance spectrum corresponding to Tryptophan, Tyrosine and Phenylalanine can be used to identify changes in protein conformations. Typically second derivative UV data is assessed qualitatively to compare similarity between protein structures. With two very similar proteins it is difficult to detect minor changes visually. Here we assess the use of different statistical models to quantitatively compare the data. A modified coefficient of determination analysis is shown to positively identify minor conformational shifts with high accuracy for the majority of proteins.  This work has implications in a manufacturing and formulations environment where rapid assessment of protein structures is necessary to successful drug development.


11:30 a.m.New, Rapid and Reproducible Peptide Mapping Workflows

Rowan Moore, Thermo Fisher Scientific


Peptide mapping involves the cleavage of a protein followed by separation and identification of the subsequent peptide fragments. LC-MS and LC-MS/MS methods for peptide mapping have been widely employed in proteomics for primary sequence determination, post translational modification (PTM) identification and quantitation. Global regulatory agencies, including US FDA and European Medicines Agency, look to harmonized guidelines from the International Committee on Harmonisation. ICH Q6B covers the test procedures and acceptance criteria for biologic drug products and these guidelines specify the use of peptide mapping as a physicochemical characterization technique for biologic drug products.  The biopharmaceutical industry demands reproducible peptide mapping workflows for identity and purity testing, comparability testing, PTM identification and quantitation and lot release testing. In this presentation you will learn about a robust, standardized workflow that is faster, more reliable and reproducible, and also easier to use than other, more traditional workflows. From protein digestion to UHPLC, MS and data evaluation the workflow provides all the tools needed for robust peptide maps providing primary sequence confirmation, sequence variant and PTM identification/localization, disulfide bridge assignment, N-terminal and C-terminal sequence confirmation.


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