Thermo Fisher Scientific and BioAnalytix Collaborate to Develop Advanced Biopharmaceutical Analysis Workflows

11 Jun 2014
Sarah Thomas
Associate Editor

Product News

Scientists at Thermo Fisher Scientific and BioAnalytix, Inc., of Cambridge, MA, are combining their expertise to develop advanced analytical profiling platforms and applications to characterize biologic and biosimilar drugs.

Biologic drugs, such as therapeutic monoclonal antibodies, are extremely large and complex biomolecules, and represent one of the most significant areas in the pharmaceutical industry today. Minor differences in biologic structure from drug to drug, or from manufacturing lot to manufacturing lot, however, can profoundly affect these drugs’ safety and efficacy profiles.

Sophisticated analytic workflows are therefore required to characterize the molecules accurately and ensure reproducible consistency during their development, scale-up and manufacturing processes. As respective leaders in analytic system performance and precise biologic analysis, Thermo Fisher and BioAnalytix are collaborating to develop advanced analytical profiling standards to support, enable and accelerate biologic and biosimilar drug development.

Under the collaboration, BioAnalytix’s team of biologic drug experts will use Thermo Fisher Scientific’s Orbitrap-based mass spectrometers, along with the company’s sample preparation, separation/enrichment, standards, reagents and software to develop advanced applications

“In partnership with top pharmaceutical companies and technology leaders like Thermo Fisher Scientific, it is our goal to establish and leverage leading analytical profiling standards in advancing the development, manufacture and regulatory approval of biologic and biosimilar drugs worldwide,” said Kirt Poss, President and CEO of BioAnalytix.

“This is an exciting real-world opportunity to showcase the ability of our technologies to provide unique, critical insights into protein structures” said Ken Miller, vice president, marketing, for Thermo Fisher Scientific’s life sciences mass spectrometry business. “We have a long history of successful collaboration with BioAnalytix scientists, and we look forward to continuing this productive relationship.”

Thermo Scientific Exactive Plus Orbitrap LC-MS

Thermo Fisher Scientific

The Exactive Plus Orbitrap LC-MS is a benchtop full scan mass spectrometer designed for compound identification and high-throughput, high-performance screening. The Exactive Plus delivers high resolution accurate mass (HRAM) data and fast, reproducible results for qualitative and quantitative analysis. The availability of HRAM and full scan capability gives you all the data, all the time. It allows retrospective data analysis and eliminates MS method development leading to improved and simplified analytical throughput.Exactive Plus is easy-to-use, cost effective to operate and coupled with workflow-driven software, makes an ideal instrument for new users in routine analytical laboratories.Selected benefits of the Exactive Plus are specified below: High Resolving Power (up to 140,000) - Eliminates isobaric interferences to increase confidence for analysis or complex samples Mass accuracy - Better than 1ppm in full scan and AIF scan using fully automated AGC and mass calibration procedures offers confident identification U-HPLC Scan Speed - The 12Hz scanning frequency of Exactive Plus is fully compatible with U-HPLC and ensures exact mass measurement for fast chromatography applications Fast Polarity Switching - A full cycle of 1 positive and 1 negative scan is performed within 1 second at a resolution setting of 35,000 without sacrificing mass accuracy All-Ion-Fragmentation (AIF) - With multiple dissociation techniques; in source collisional induced dissociation (CID) and high energy collisional dissociation (HCD), provides MS and MS/MS data Full MS scan, AIF scan, data dependent AIF, alternating Full MS and AIF scan Intuitive software interface The Exactive Plus Orbitrap LC-MS is ideal for the following applications: Environmental and Food Safety Clinical Research Forensic Toxicology Drug discovery, metabolism and pharmacokinetics (DMPK) Metabolomics Pharmaceutical BioPharma – Intact Protein analysis Laboratories analyzing food, pharmaceuticals, neutraceuticals, and other complex samples can now purchase Exactive Plus LC-MS system equipped from the factory with IonSense ID-CUBE™ ion sources. This configuration is designed to minimize the need for sample preparation to simplify and speed analyses.

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Thermo Fisher Scientific and BioAnalytix Collaborate to Develop Advanced Biopharmaceutical Analysis Workflows