New UHPLC-MS Workflows Designed for Biopharmaceutical Characterization

Biopharmaceutical companies can now achieve advanced levels of specificity, sensitivity and speed with specialized analytical workflow solutions for the characterization and quantification of proteins. 

These new and comprehensive workflow solutions for in-depth biopharmaceutical characterization are on display at Analytica 2016 (Messe München, booth 101, hall B1) in Munich, Germany. 

“Characterization and quantitation of biomolecules is challenging and scientists require user-friendly instruments and complementary consumables and software to help them develop safe and effective drugs faster,” said John Rontree, senior director of biopharmaceutical marketing, chromatography and mass spectrometry, Thermo Fisher. “We’ve developed application-based analytical workflows that enable our customers to gather more information about novel therapeutics earlier in the research and development process. By offering a complete solution from a single provider, our customers can be confident that their complete characterization is supported by our global service network.” 

The complete workflows, which include solutions for everything from sample prep to data analysis, feature the following new instruments, consumables and software:

• The new Thermo Scientific DNAPac RP columns are designed to separate and characterize DNA/RNA oligonucleotides and longer double-stranded (ds) DNA fragments (up to 10k bp), with high resolution, using reversed-phase HPLC and LC/MS. With this new line of HPLC columns, the company now offers analytical HPLC columns for both reversed-phase (RP) and anionexchange chromatography. The high-throughput columns, for single- and double-stranded DNA fragments, offer high-efficiency with low carry-over, easy compatibility with LC/MS and rugged thermal and pH stability. As the need for analyzing long oligonucleotides associated with next generation sequencing and purity analysis grows within the biopharma community, these new columns feature packing material which is optimized for reversed-phase HPLC or LC/MS of oligonucleotides. The DNAPac RP columns are used on the Thermo Fisher’s Thermo Scientific UltiMate 3000 BioRS System and Thermo Scientific Vanquish HPLC system.

• The Thermo Scientific SMART Digest Kit is a protein digestion kit for biopharmaceutical applications that require reproducible, sensitive and fast, bottom-up analysis of proteins in highthroughput workflows. Designed to minimize preparation time and variability, the SMART Digest kit facilitates fast and reliable analytical results using a simple three-step, easy-to-implement process that can also be automated. The immobilized trypsin design is formulated to produce high-quality data with reduced sample preparation time compared to traditional in-solution digestion methods. 

• The new Thermo Scientific Vanquish Flex UHPLC System is a fully bioinert ultra high performance liquid chromatography (UHPLC) offering that delivers exceptional performance and reliable separations with the flexibility required for labs developing methods ranging from highthroughput analyses to pharmaceutical quality control applications. The Vanquish Flex system is designed for high speed, resolution and sensitivity, allowing researchers who perform biopharmaceutical analyses to obtain high-quality and consistent data. Because it features integrated modularity, customers can mix and match modules depending on the demands of the application. Biopharmaceutical partners already using the system note its ultra-low baseline noise, retention time reproducibility and peak profile reproducibility. 

• The Thermo Scientific Dionex Chromeleon 7.2 Chromatography Data System provides a workflow that allows scientists to answer questions that frequently arise during method development. 

• The Thermo Scientific MAbPac RP column is designed for analytical chemists requiring highresolution separation of intact proteins, such as monoclonal antibody (mAb) variants and antibody drug conjugates (ADCs) as well as those conducting high-resolution mass spectrometric analysis of mAbs and mAb fragments. This column addresses the increased need for reliable and rapid characterization of these compounds required for upstream biopharmaceutical development. The MAbPac RP column is targeted for MS and UV detection: its thermal and pH stability yields promote consistent separations, while the polymeric resin has a pore size suitable for mAbs. 

• The new Thermo Scientific BioPharma Finder software is designed to provide intelligent batch/lot comparisons to promote consistency and quality throughout. For intact mass analysis, BioPharma Finder uses two deconvolution algorithms to take advantage of the high-quality, highresolution accurate mass (HRAM) data produced by Thermo Scientific Orbitrap-based mass spectrometers, such as the Thermo Scientific Orbitrap Fusion Lumos Tribrid Mass Spectrometer. For peptide mapping workflows, BioPharma Finder facilitates confirmation of amino acid sequence and identification of the site and type of expected and unexpected post-translational modifications (PTMs), and it provides the relative amount of each modification. Additional features include disulfide bond mapping and low-level impurity identification.

For a closer look at Thermo Fisher’s new UHPLC-MS workflow solutions for biopharmaceutical characterization, visit Thermo Fisher at Analytica booth 101, hall B1 or, more for information, visit http://www.thermoscientific.com/UHPLC