This story originally ran on Jan. 26.
By Tony Fong
Tapping into a customer segment that may want the performance of an Acquity UPLC but may not be ready to make a complete transition from an HPLC system, Waters this week introduced its Acquity UPLC H-Class System.
The system is designed specifically for researchers "who have been attracted by the promise of UPLC but remain reluctant to change largely because of their comfort levels with existing HPLC systems and techniques," Rohit Khanna, Waters' vice president of worldwide marketing, said during a conference call with reporters.
"To reach the broader market, we needed to provide a bridge to UPLC performance that builds upon the widespread knowledge and comfort that laboratories have with HPLC operation," he said.
According to Khanna, the H-Class is meant to replace conventional HPLC systems: Because methods development can now be "seamlessly" transferred from an HPLC to a UPLC, or vice versa, Acquity capabilities can now be achieved by "routine analysis labs."
Art Caputo, president of the Waters division, said in a video presentation that because of "regulatory requirements, technical capabilities, and a variety of other reasons," scientists have felt justified in holding onto their HPLC technologies. The H-Class, he said, will drive adoption of the Acquity UPLC.
According to the company, the new platform offers the flexibility of a quaternary-based HPLC, but a new quaternary solvent manager, QSM, and sample manager, SM-FTN, with flow-through needle design mimics the HPLC system workflow. In addition, the H-Class can support existing HPLC methods "where, for whatever reason, the method cannot be changed," Khanna said.
The QSM and SM-FTN combine for high-separation efficiency using sub-2 micron particle separations at high pressures.
Acquity UPLC columns are also available in three particle substrates in 11 chemistries, all scaleable between HPLC and UPLC particle sizes. Also introduced in conjunction with the new platform is a new Acquity UPLC Method Transfer kit containing both UPLC and HPLC columns with specified chemistry, and an Acquity UPLC Columns Calculator to aid in method transfers.
Method development and method validation kits are available "to ensure efficient method development and robustness," Waters said in a statement.
The H-Class will be showcased at Pittcon next month in Orlando, Fla.
Company officials declined to disclose pricing for the H-Class, but during the company's 2009 fourth-quarter earnings call this week [See related story, this issue], they said that it would be between 5 percent and 7 percent above the price of Waters' traditional HPLC systems, but priced lower than the Acquity. Waters is taking orders on the instrument now and will ship it 30 days from order placement.
When Waters launched the Acquity in 2004, the instrument represented a technological breakthrough in liquid chromatography technology, offering sub-2 micron particles packed into a 10 cm column, which were subjected to 15,000 psi of pressure. The results were significant improvements in peak height, resolution, and sensitivity over HPLC systems [See PM 03/12/04].
In the six years since its launch, other firms have introduced ultra-high-performance LC systems — most notably Agilent Technologies, which debuted its 1290 UHPLC last spring as a direct competitor to the Acquity [See PM 04/30/09].
But in the ultra-high-performance LC space, the Acquity is still regarded as the standard that other manufacturers are trying to match. In a research note during the summer, Isaac Ro, an analyst at investment firm at Leerink Swann, said that despite positive feedback on the 1290, Agilent would "require a long ramp before gaining significant market share," and that the Acquity has a "considerable leadership position, a large installed base, and a wide menu of proprietary columns."
In addition, commercial lab processes for QA/QC using UHPLC technology are often regulated by the US Food and Drug Administration "and thus carry high switching costs," he noted [See PM 06/25/09].
[ pagebreak ]
At the recent JP Morgan healthcare conference in San Francisco, Waters President and CEO Douglas Berthiaume also thumped his chest, saying that the firm's competitors in the space have been "slow to catch [up], and the Acquity UPLC continues to be what would drive the future of chromatography forward."
Waters has also built on the Acquity technology. Soon after launching the platform, the company introduced the nanoAcquity designed to handle the low flow rates and high pressure required for most sample-limited proteomics experiments.
Two years ago, it brought to market the Patrol UPLC Process Analyzer, which uses the same technology as the Acquity, for the detection and quantification of complex multiple component manufacturing samples and final product directly on the production floor.
This week, Waters said it has installed thousands of UPLC systems, which have replaced tens of thousands of HPLC systems, the company said. Among those who have acquired an Acquity platform are the US Food and Drug Administration; General Electric; Merck; Wyeth Pharmaceuticals, which is now part of Pfizer; and Genzyme.
Mary Ellen Goffredo, Waters' senior director for systems marketing, said that the Acquity has been one of the most successful technologies ever developed by the company, but there continued to remain questions among customers on how to more broadly incorporate a UPLC workflow into their own labs.
Responding to a question, she said that the H-Class was not developed in order to address any reluctance from the market to the Acquity UPLC.
"I'm not sure I would characterize the reaction to the [Acquity] as resistance, but really rather as, 'We really like this technology. How can we get it into our labs more rapidly?'" she said.
Even among some customers who had purchased an Acquity, there was a desire for an instrument that would help them migrate away from HPLC to true UPLC performance, Goffredo said. The H-Class was designed so that customers who currently run HPLC separations would be able to transfer them to the H-Class, "and then when they're ready, [we can] migrate them to true UPLC type technology."
Company officials, however, stressed that while the H-Class is to help segue researchers from HPLC to UPLC platforms, the H-Class is a UPLC system, albeit one that operates with "HPLC simplicity" so that customers can eventually move into UPLC mode, Khanna said.
When transferring existing validated methods among LC systems, issues often come up that are inherent with system designs, Patricia McConville, Waters' manager of systems marketing laboratory, said. Researchers will often have to make accommodations for differences in system volume, or in column heating.
The H-Class incorporates tools, such as the UPLC Columns Calculator, to facilitate the transfer of methods from an HPLC to the H-Class.
"We have the ability to scale from HPLC to HPLC [while] maintaining existing performance characteristics, and then to scale again to UPLC," McConville said.
Waters has also introduced active pre-column heating into the H-Class system, which assures that the mobile phase entering the column is at the set temperature. "This will accommodate drastic differences in room temperature or differences from system to system," McConville said.
For proteomics research, the H-Class is "a very amenable pump for applications using long shallow gradients," such as peptide mapping or protein identification, Jeannine Jordan, Waters' senior product marketing manager added.
The validation requirements for both HPLC and UPLC are the same, she said.
The Acquity still offers some advantages over H-Class, especially for enhanced mass spec performance or "ultimate" throughput, Khanna said. The Acquity is best suited for "very fast" cycle times or ultra-low system volumes, he added.
But "if the challenges stem from routine testing laboratory, or the need to improve method development and method transfer capability," the H-Class system would be a solution, he said.