Going out on a LIMS
Millipore’s CRO unit implements Thermo Fisher Scientific’s Watson LIMS for information management
The LIMS deployment, announced in December, will be used bythat group's Regulatory Compliant Laboratory in the development, validation andapplication of ligand binding assays that enable the development ofbiopharmaceuticals and translational biomarker applications. The system wentlive at the end of December and will specifically be used by the group in itsimmunogenicity testing, determination of novel biomarkers and pharmacokinetic(PK) assessment of biotherapeutics. Financial terms of the deal were notreleased.
Millipore will also use Thermo Scientific IntegrationManager to provide the connectivity necessary to enable Watson LIMS to be fullyintegrated with the laboratory's instrumentation, other proprietary databasesand ERP systems enterprise-wide, as well as Thermo Scientific Designer, areporting system for the data created and stored in the Watson database. Theinstallation of these tools will integrate Millipore's Regulatory CompliantLaboratory with the rest of the organization, enabling management to haveaccess to critical laboratory data when they need it, and in a format that willallow for improved management decision-making, says Craig Morley, globalmanaging director for Millipore's BioPharma Services business.
"Watson is the recognized, proven and relied-upon industrychoice for laboratories providing pharmacokinetic and ADME/Tox services,"Morley says. "We looked at most of the top 20 pharma, and many of them useWatson LIMS. Before, we were using Excel spreadsheets and manual systems. Now,the implementation of Watson LIMS will centralize a lot of data, allow us tointegrate with clients who also use the LIMS system and export data.Integrating the Watson database with the rest of the organization enables us tomake better informed management decisions and deliver superior services to ourcustomers."
Watson LIMS will definitely make the process of samplehandling easier, Morley says, and the fact that it is a closed system also hasits benefits, he adds.
"This made it easier to validate and implement versus anopen system, because a lot of customization is taking place internally,especially with PK assays and biomarkers," he says.
What's more, Thermo Fisher Scientific's team was able toimplement the system in less than a year, Morley adds.
"Thermo Fisher Scientific has high-level project managerswho were able to get the project moving along, validated and live in less thana year, so they were an excellent partner to work with," he says. "We're goinglive the last week of December with our biomarker and PK assay studies, andafter the first of the year, we will go live with our immunogenicity testing."
Jim Brennan, a senior business consultant for Thermo FisherScientific, says Watson was specifically designed for drug metabolismpharmacokinetic laboratories with pharmaceutical or biotech companies or theCROs that work with them.
"Watson does not require costly customization and there isminimal configuration that needs to be done, which means that implementation,validation and upgrades happen much more quickly than is typical in genericLIMS," Brennan says. "Millipore can reap that benefit, and Watson also has a numberof features to support the drug approval requirements of Millipore's RegulatoryCompliant Laboratory."
According to Kim Shah, vice president of marketing andbusiness development at Thermo Fisher Scientific, Millipore's Watsonimplementation is a demonstration of the company's CONNECTS initiative.Consisting of a set of products, technologies and services—delivered by ThermoFisher Scientific in conjunction with many industry-leading players, such asMicrosoft, SAP, Oracle, Symyx and the Thermo Scientific Global PartnerAlliance—CONNECTS seeks to improve the transfer of knowledge betweenlaboratory-generated data and enterprise-level information systems.
"We recognize that our customers are increasinglyglobalizing and/or outsourcing a lot of their work," Shah says. "No longer dothey have everything happening in one laboratory or in one place, soconnectivity to a variety of instruments, software and outsourced contractorsystems are becoming more of a necessity for our customers."
Millipore's BioPharma Services organization providescontract research services to the pharmaceutical and biotech industries througha wide range of bioanalytical services and capabilities supporting discovery,lead optimization, ADME/Tox and Phase I-V clinical trials. These servicesinclude bioanalysis of biotherapeutics, antidrug antibody testing, assays fornovel biomarkers and other specialty services.
Morley says Millipore is considering implementing other LIMSsystems across its various divisions.
"The biggest challenge most companies face when it comes todata management is the integration of multiple systems," he says. "Having aclosed system is a positive thing, but on the other hand, it lacks some of thecustomization ability we need in our other segments. Going forward, the companyis looking at the functionality of these different LIMS systems and assessinghow to maximize them."