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Firms Working to Co-Develop Automated Biotherapeutic Characterization Workflows, Combining Genovis SmartEnzymes™ and Waters LC-MS Instrumentation.
  • Collaboration intended to bring speed and simplicity to bio-characterization workflows

  • Automated workflows to cut the time and effort required to monitor critical quality attributes of biotherapeutics in regulated laboratories

  • Waters and Genovis share mutual goal to advance the science behind the analysis of glycoproteins and protein therapeutics

Genovis and Waters (NYSE:WAT) are formally collaborating to develop and market complete routine biopharmaceutical characterization workflows based on  Genovis SmartEnzymes[TM] (https://www.genovis.com/)and the Waters™ BioAccord™ LC-MS System (https://www.waters.com/waters/en_US/BioAccord-LC-MS-System-for-Biopharmaceuticals/nav.htm?cid=135005818&locale=en_US),Andrew+ pipetting robot (https://www.andrewalliance.com/pipetting-robot/). The goal of the collaboration is to develop automated workflows for the rapid and consistent characterization of critical quality attributes (CQAs) of monoclonal antibodies (mAbs) and other protein-based drugs in bioprocess development, formulation, stability testing and quality control (QC).

" The BioAccord SmartMS™ system and the Andrew+ aligns perfectly with our strategies and vision at Genovis to bring simplified, robust and automated enzyme-driven workflows to the biopharma industry said Fredrik Olsson, CEO, Genovis AB. "The enzymatic workflows that we will develop in collaboration with Waters will help our customers in their efforts to bring safe and novel therapeutics to patients, faster."

"Biologics analysis is an area that is ripe for improvement. What takes analytical scientists several days to do, should take hours or minutes instead," said Jeff Mazzeo, Vice President, Global Marketing and Scientific Operations, Waters Corporation. "Today, up-front sample preparation is a major bottleneck to productivity, largely due to the number of manual steps involved and the outmoded technology by which samples are readied for analysis. By combining Genovis' SmartEnzymes with automation, liquid chromatography/time-of-flight mass spectrometry and application-specific software workflows from Waters, we intend to move biotherapeutic analysis forward in ways never thought possible." 

The workflows in development are based on the pairing of the Waters BioAccord LC-MS System, Andrew+ pipetting robot and Genovis SmartEnzymes and will focus on addressing the application needs of GxP laboratories in the following areas:
  • Product variant analysis [e.g. glycosylation, oxidation]
  • Bioprocess stability monitoring
  • Biosimilar glycosylation analysis

Additional Resources

Visit the Waters web site: BioAccord LC-MS System for Biopharmaceuticals (https://www.waters.com/waters/en_US/BioAccord-LC-MS-System-for-Biopharmaceuticals/nav.htm?cid=135005818&locale=en_US)

Watch the video: Multi-Attribute Method Overview (https://videos.waters.com/detail/videos/bioaccord-system-demo/video/6220164373001/multi-attribute-method-overview-%7C-bioaccord-system-demo-series-%7C-part-1-of-5?autoStart=true)

Visit the Genovis AB website for information on Genovis SmartEnzymes (https://www.genovis.com/)

Visit the AndrewAlliance website for information on the Andrew+ Pipetting Robot (https://www.andrewalliance.com/pipetting-robot/)

Visit Genovis Blog (https://www.genovis.com/blog/genovis-teams-up-with-waters-to-deliver-enzymatic-workflows-for-the-biopharma-industry/)
 

About Waters Corporation (www.waters.com (https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.waters.com&esheet=52019957&newsitemid=20190729005407&lan=en-US&anchor=www.waters.com&index=8&md5=66790a79b54c31501736c9d59440f7b9))

Waters Corporation  (https://www.waters.com/nextgen/us/en.html)(NYSE:WAT), the world's leading specialty measurement company, has pioneered chromatography, mass spectrometry, and thermal analysis innovations serving the life, materials, food and environmental sciences for more than 60 years. With more than 7,400 employees worldwide, Waters operates directly in 35 countries, including 14 manufacturing facilities, and with products available in more than 100 countries.

Waters, BioAccord, SmartMS, Andrew Alliance and waters_connect are trademarks of Waters Corporation.

Waters Contact: Brian J. Murphy, PR Manager, Corporate Communications Waters Corporation, [email protected],+1 508-482-2614

Genovis AB provides enzymes and technologies for analytical characterization and conjugation of biopharmaceuticals. The principal activities of the company are to develop, produce and market tools for developing new drugs and diagnostics. The Genovis product line comprises of GingisREX, FabRICATOR, GlyCLICK, GingisKHAN, GlycINATOR, Fabulous, lgGZERO, and Enzymes for O-glycan. The company serves mainly the medical device and pharmaceutical industries.