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Two for biopharmaceutical characterization
August 2016
by Mel J. Yeates  |  Email the author
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WALTHAM, Mass. & DUBLIN, Ireland—Thermo Fisher Scientific and the National Institute for Bioprocessing Research and Training (NIBRT) have announced a scientific collaboration focused on the development of analytical solutions for the characterization of complex biopharmaceuticals.
 
Biopharmaceuticals represent protein molecules produced by genetically engineered living cells using large-scale industrial bioprocessing. The complexity of these molecules requires advanced analytical characterization strategies to ensure that biopharmaceuticals are produced to the highest possible quality level.
 
“We are delighted to be working with Thermo Fisher,” said Dominic Carolan, CEO of NIBRT. “World-class collaborations such as this are testament to Ireland’s emergence as a global center of excellence in all aspects of biopharmaceutical manufacturing.”
 
Dr. Jonathan Bones, principal investigator at NIBRT’s Characterization and Compatibility Laboratory, says that NIBRT and Thermo Fisher Scientific have been in discussions for a few years regarding potential collaborations. Since both parties have common scientific goals, their discussions led to the announcement of this most recent collaborative project, along with a number of ongoing research interactions.
 
“NIBRT and Thermo Fisher are actively collaborating on a number of projects. These projects include the comprehensive characterization of extractables and leachables from single-use solutions for biomanufacturing, and also deep proteomic studies of monoclonal antibody producing CHO cell lines to understand the interplay between cellular behavior, productivity and product quality,” says Bones. “These projects involve interaction of NIBRT scientists with Thermo Fisher research scientists and application specialists to develop and apply Thermo Fisher’s world-leading analytical instrument portfolio, reagents and molecular technologies, in order to address key challenges facing those involved in biopharmaceutical manufacturing.”
 
“NIBRT and Thermo Fisher have had several focused successful collaborations in place to answer discrete scientific questions,” says Claire Wallace, vice president and general manager for Chromatography Consumables at Thermo Fisher Scientific. “Expanding this to a formal collaboration was the next logical step, and we are excited to be working more closely with NIBRT as a universally respected, global centrer of excellence for training and research in bioprocessing.”
 
This collaboration will see NIBRT develop workflows on the Thermo Scientific biomolecule column range with its associated consumable portfolio, in conjunction with Thermo Scientific liquid chromatography systems and Orbitrap high-resolution mass spectrometers.
 
“This collaboration is important because it enables our team to access Thermo Fisher’s world-leading columns and analytical instrumentation to develop total analytical solutions and streamline the characterization of complex biopharmaceuticals,” said Bones. “The availability of total analytical solutions to scientists across the world is empowering and motivates us at NIBRT to continually perform excellent impactful research.”
 
Bones tells DDNews that partnering with Thermo Fisher gives NIBRT unprecedented access to the expertise behind the products, allowing them to pass this knowledge to the wider bioprocessing industry. Thermo Fisher benefits from access to NIBRT’s vast and intimate understanding of the BioPharma industry, its needs, the trends and its core values.
 
“Analytical characterization of biopharmaceuticals remains a challenge for scientists and requires cutting-edge chromatography solutions and mass spectrometry detection,” Wallace says. “By using Thermo Fisher’s biomolecule columns and analytical instrumentation, NIBRT will be able to provide insights to help Thermo Fisher further evolve our technology, simplify analysis, generate informative characterization data and understand complex molecules. Our shared focus in the biopharmaceutical industry makes this a powerful collaboration aligned to the needs of both organizations. The overriding goal in all of this is to enable scientists to move from sample to knowledge quickly and efficiently.”
 
According to Wallace, the most important impact of the collaboration is its cross-pollination of ideas between organizations, which will drive future NIBRT research and Thermo Fisher product development.
 
Bones says Thermo Fisher and NIBRT will be working on a number of discrete projects. “Initially, Thermo Fisher will develop workflows that enable us to fully characterize the critical quality attributes of existing biopharmaceuticals. Longer term, NIBRT will develop bespoke molecules that will help us develop analytics that critically assess the whole bioprocessing workflow, improving our understanding of the critical points in the process that lead to final product variability and allowing us to better control them.”
 
NIBRT’s workflows and methods will be uploaded to the Thermo Scientific AppsLab library, a unique cloud-based applications compendium that enables scientists across the globe to access and download these total analytical solutions directly to their instruments, enabling them to simplify their analysis, generate highly informative characterization data faster and understand their complex molecules better.
 
Code: E081609

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