New System Gives Biopharm The Power Of UPLC
By Lori Clapper, Web Editor
Last week, I traveled to the Waters Corporation in Milford, MA, to visit with several members of the the company's team about their new ACQUITY UPLC H-Class Bio System. Considering the company had just released the ACQUITY UPLC H-Class System in January 2010, I wondered why there was a need to release a new version so quickly. I quickly learned that this new system was a version "fit for purpose" for the biopharmaceutical market.
To best understand this new bio product, you first need to understand the original H-Class system. Essentially, this product links the high-performance of UPLC with the simplicity of HPLC. It fully supports both columns and makes future transition from HPLC to UPLC more practical in all phases of product testing. In addition, tt is also based on QbD methodology for LC method development. Waters cites a pharmaceutical company that reduced its method development time for a complex drug product from 45-60 days to only two days by using the ACQUITY UPLC H-Class.
Jeannine Jordan, product marketing manager for Waters, explained to me that many of the company's biopharm customers liked the H-Class System, but wanted it to be customizable for their market.. "They needed a system that would be flexible to run all modes of chromatography in the biopharmaceutical market including ion exchange, size exclusion, and even reversed phase," she explained.
Because of the complexity of large molecules like proteins, peptides, nucleic acids, and glycans, biochemists have used "piecework" chromatographic systems. But this new Water's bio system changes that. Its columns are designed for specific bio-separations, and it's constructed of inert materials that are resistant to corrosion and suited for high ionic strength aqueous conditions used for protein separations. Dr. Jeffrey Mazzeo, biopharmaceutical business director at Waters, claims the ACQUITY UPLC H-Class Bio System gives the biopharmaceutical market "better results, better reproducibility, longer system length, and better recovery than when they run their applications in a non-stainless steel system." He believes this system is the key for a wider adoption of UPLC technology.
During my visit, I also was permitted to tour one of the company's labs where I met scientist Dr. Thomas Wheat and received a hands-on demonstration of the new Bio System. To watch a video of this demonstration and my interview with Dr. Wheat, click here. You also can view the video of my visit with Dr. Mazzeo and Jeannine Jordan here.