Large Molecule Bioanalysis/DMPK

The rise in large molecule biotherapeutics, which are more complex and challenging to analyze, has increased the demand for peptide bioanalysis using mass spectrometry. High resolution accurate mass orbitrap technology provides ultimate selectivity for the analysis of biotheraputic peptide based products. A unique combination of innovative technologies provides a workflow with superior quantitative accuracy and sensitivity.

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The InsuQuant Mass Spectrometric Kit is an affinity purification clean-up kit used to extract endogenous insulin and exogenous insulin analogues from plasma for further analysis in LC-MS. Porous microcolumns are coated with an insulin-specific affinity ligand, targeted to capture insulin and its exogenous analogues. Through repeated pipetting of the matrix, the analyte of interest is put into contact with the antibody-coated surface on the microcolumn.

Obtain high quality analytical results from protein digests by using Thermo Scientific SMART Digest Kits. A significant advance in sample preparation for biopharmaceutical and protein research, the kits provide fast and simple protein digestion with high reproducibility, high sensitivity, and high levels of data quality in a format that is compatible with automation. SMART Digest kits result in less autolysis than from traditional in-solution trypsin digestion, and usually results in no unspecific cleavage. The digestion enzyme can be use in excess so there’s no need for careful measurement. This means vastly accelerated proteolysis and no enzyme to substrate adjustment.

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Remove variability and optimize high throughput laboratory workflows. Thermo Scientific SOLAµ Solid Phase Extraction (SPE) Plates are designed for bioanalytical and clinical research analysts who require clean, reproducible, and robust sample extraction using very low sample and solvent volumes in high throughput workflows. SOLAµ Well Plates achieve this due to the unique and award winning innovative frit-less SPE technology.

Thermo Scientific Vanquish Flex UHPLC system is a new biocompatible chromatography system with state-of-the-art quaternary solvent blending. The Vanquish Flex system delivers new benchmarks in accuracy, precision, and sensitivity with a state of the art quaternary pump. The Vanquish Flex system shares all Vanquish portfolio values; such as robustness and reliability. Multiple detection options as well as Thermo Scientific Viper Fingertight Fitting connections throughout the system will give you the performance you need with the ease of use you want. Vanquish Flex UHPLC is engineered for extremely reproducible peptide separations and exceptionally small retention time deviations.

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Identify, quantify and confirm more peptides rapidly and with confidence using the Thermo Scientific Orbitrap Exploris 240 Mass Spectrometer. This compact LC-MS/MS system combines quadruple precursor ion selection with high-resolution, accurate-mass (HRAM) Orbitrap detection to deliver exceptional performance and versatility.

Study design and analytics to support bioanalysis and DMPK for drug development require high sensitivity mass spectrometry (MS) data and attention to fine detail to manage even the smallest peaks. Thermo Scientific Chromeleon Chromatography Data System (CDS) provides the tools for quick and robust quantitative MS analysis. With full integration of Thermo Scientific gas chromatography (GC)-MS/MS and liquid chromatograph (LC)-MS/MS instruments, as well as more than 550 other instruments from over 25 different vendors, Thermo Scientific Enterprise Chromeleon CDS connectivity facilitates quick method development, seamless method qualification/validation, and streamlined method transfer across laboratories on a global scale while ensuring data integrity requirements for a cGxP environment are met with the secure data vault structure and suite of compliance tools. Confidently run your bioanalytical and DMPK studies from any lab at any site at any time with the stability and performance of Chromeleon CDS.

From confident screening, confirmation and quantitation of unknowns to the identification of known unknowns, TraceFinder software maximizes laboratory productivity, no matter your level of experience, by combining instrument control, templated methods and reporting.

The Thermo Scientific Watson LIMS Software for Bioanalytical Laboratories, installed in 18 of the top 20 global pharmaceutical organizations, is widely used in leading biotechnology and contract research organizations worldwide. The Watson LIMS facilitates efficient study design and data transfer while streamlining assay validation, bioanalysis, instrument interfacing, sample tracking, results reporting and regulatory compliance.

Troy Voelker of Covance discusses why they chose the Q Exactive systems for HRAM MS bioanalysis of oligonucleotides and other novel therapeutics.