Thermo Seeks to Industrialize ADME/Tox Testing


By Salvatore Salamone Bio-IT World
(02/02/05)—Thermo Electron on Tuesday introduced the LeadStream ADME/Tox Solution, a turnkey testing system that combines sample preparation, assaying, and mass spectroscopy systems with workflow and data management software.

The LeadStream system was announced at the ALA (Association for Laboratory Automation) LabAutomation2005 conference being held in San Jose this week.

Thermo Electron’s aim with the system is to industrialize the in vitro ADME/Tox (absorption, distribution, metabolism, excretion, and toxicity) testing process – a process that is increasingly seen as a bottleneck in drug development.

For example, simple chores like preparing sample plates or ensuring that the appropriate chemicals and reagents are available for a test are time-consuming tasks that are seldom well organized in life science companies today.

Typical ADME/Tox systems have discrete subsystems such as devices that reformat samples from master plates to daughter plates (which contain samples that are actually tested); materials handing systems; equipment to conduct assays; and a mass spectroscopy system. In some cases, these individual systems run efficiently, but there is very little effort in coordinating the entire process.

For the discrete steps in the test process, “you have islands of automation,” says Robert DeWitte, business relationship manager for ADME/Tox in Thermo Electron’s Life and Laboratory Sciences group. Frequently, each subsystem is optimized for its task, “but each sub-system does not work or integrate with the other systems,” says DeWitte. “Often the researcher is the glue that ties the systems together.” Essentially, the task of managing an experiment’s flow between the various subsystems is dumped in the researcher’s lap.

Noting these issues, Thermo Electron developed the turnkey system with software that integrates and manages the discrete subsystems. The system includes the LeadStream Reformatter, which prepares and distributes plates of samples offline to speed the testing process; LeadStream Workcell, which conducts ADME/Tox assaying; LeadStream LC/MS, a system that performs mass spectroscopy tests of samples; and LeadStream Orchestrator, the software that manages laboratory workflow and tracks samples, data, and work requests throughout a lab.

The Orchestrator software collects data into a single database and offers connectivity to LIMS systems. It also simplifies logistics by “preparing the right plates, for the right assays, at the right time,” says DeWitte. For example, the system can set up a process whereby mother plates with samples to be tested go to a reformatting workcell that makes daughter plates offline. This parallel preparation of plates means that a production system does not have to be taken out of service to perform this task, according to DeWitte.

Another feature of the software is that it lets a scientist set up what Thermo Electron calls “assay triage decision logic.” For instance, a researcher can set up a pass/fail criterion to do, for example, a metabolic stability assay only if a sample’s solubility is greater than a certain value. “If the [assay] passes the criterion, the reformatting workcell prepares daughter plates in real time.” says DeWitte. “The [researcher] doesn’t have to wait for the entire batch to be run to start the process.”

Focus on Data Management
The LeadStream ADME/Tox system represents a move by Thermo Electron into a slightly different market than it has been serving.

The company has had a strong presence in the life sciences. About 70 percent of its revenues come from what it calls the life and laboratory sciences market. But its main thrust to date in the life science market has been in instruments and reagents.

The bottom line is that, until recently, the company focused much of its attention on the lab scientist. “[We’ve] traditionally tailored our products to the scientists,” said Marijn Dekkers, Thermo Electron’s president and CEO, at the UBS Global Life Science Conference held last fall in New York.

In his speech at the conference, Dekkers noted that the company knew it had another type of customer – what he called “the boss of the scientist, the lab manager.”

“We’ve ignored the lab manager in the past,” said Dekkers. “Lab managers have not gotten much help by the instrument industry.” He noted that this was something that companies in the industry, in general, and Thermo Electron, in particular, are now addressing.

To that end, Thermo would “continue to [make] top-quality instruments for the scientist, but it would also tailor solutions to help lab managers run their labs,” said Dekkers.

LeadStream, with its management software, is an example of this focus on the lab manager. In another move in this same vein, Thermo Electron acquired the laboratory information management system (LIMS) vendor InnaPhase last year.

Other equipment and supply companies, most notably Waters and PerkinElmer, are also addressing this same lab manager/data management issue. For instance, over the last year Waters acquired an electronic lab notebook company and a LIMS vendor to provide infrastructure tools to manage experimental data.






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