April 8, 2019

Genovis and Thermo Fisher Scientific Announces Collaboration to Advance Biopharmaceutical Characterization and Monitoring Workflows

Regulatory

Genovis, a leader in the development of enzymatic tools and technologies, have entered into a collaboration agreement with Thermo Fisher Scientific to develop advanced end-to-end workflows for the preparation, characterization and monitoring of novel and complex biotherapeutics using liquid chromatography-mass spectrometry (LC-MS). The collaborative partnership with Thermo Fisher aims to develop advanced end-to-end methods for the analysis of novel and complex biotherapeutics to meet the increasing demands for high throughput, rapid and simplified analytical workflows.

Bringing together Genovis advanced enzyme-based sample preparation and analysis techniques with Thermo Fisher’s leading LC-MS technology, the collaboration will develop robust automation-ready solutions and chromatography-based workflows for the streamlined analysis of biotherapeutics. Scientist at Genovis will work together with Expertise from Thermo Fisher’s Global Customer Solution Centerswill also help to determine optimal hardware/software configurations and suitable consumables for critical quality attribute (CQA) analysis of biotherapeutics during research and development.

“We are excited to continue our clear ambition towards more automated analytical workflows together with Thermo Fisher Scientific, a renowned world leader in serving science with instrumentation, technologies and consumables. Through this collaboration we will be able to develop new products and workflows on world-class instrumentation together with experts from the European Biopharma Customer Solutions Centre at Thermo Fisher, with the goal to serve the customers of both companies with innovations for the ever-growing analytical needs within the biopharma industry,” says Fredrik Olsson CEO at Genovis.

“With the shift towards large biological entities, companies are aiming to bring to market medicines with greater affinity and efficacy, but these also present an additional level of analytical complexity,” said John Rontree, senior director, global marketing and strategy, pharmaceuticals & biopharmaceuticals, Thermo Fisher Scientific. “By collaborating with Genovis, we aim to develop comprehensive workflows that provide robust and advanced solutions for preparing and assessing complex biotherapeutics, supporting the research and development of safe and effective medicines.

By combining the SmartEnzyme™ technology from Genovis with Thermo Scientific Vanquish Duo UHPLC Systems (with Dual LC workflow) and the Thermo Scientific Chromeleon Chromatography Data System (CDS) Software the collaboration aims to develop:

LC-MS-based protocols for O-glycosylation profiling of biosimilars against their originators; and
Automated high-throughput workflows for Critical quality Attributes (CQA) analysis of monoclonal antibodies at the subunit level, using a combination of automation, chromatography and high-resolution mass spectrometry.

ABOUT GENOVIS

Genovis’ business concept is to apply its knowledge and imagination to design and provide innovative tools for the development of the drugs of the future. Today Genovis sells several enzyme products known as SmartEnzymes all over the world in innovative product formats that facilitate development and quality control of biological drugs.

The Group consists of Genovis AB and the wholly owned subsidiary Genovis Inc. (USA). Genovis shares are listed on Nasdaq First North Stockholm and Erik Penser Bank is the Company’s Certified Adviser, certifiedadviser@penser.se, T: +46 (0)8-463 83 00.

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