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Thermo Scientific Nautilus LIMSBiobanking and Biospecimen ManagementLeader inFunctionality,Ease of Useand Flexibility

Leader in Functionality, Ease of Use and FlexibilityBiospecimens serve as the basis for the novel research and development needed for the discovery of tomorrow’s drugs and medical treatments. The past decade has seen a surge in the number of samples generatedfor research and analysis — largely due to the increased focus on translational medicine and epidemiology.This has led to the development of extensive biobanks and biorepositories that feed the demand for samplesand libraries to be screened by these high capacity, high throughput laboratories. With these advances, thegrowing need and focus on high quality sample yields and how they are accurately and efficiently managedis now a top concern for researchers who are often charged with managing enormous volumes of bothsamples and their relevant data.The number and size of these biobanks and biorepositories is rapidly growing, with many national, regional anddisease-specific facilities being established. The function of these biobanks is quite diverse and can range fromthe storage of frozen cell aliquots intended for primary pharmaceutical screening, to tissue biopsies for diseaseresearch, to patient DNA samples, to whole population studies containing multiple aliquots of fractionatedblood and urine samples.2The ChallengeThe Critical Role of BiobanksThe challenge that biobanks face extends farbeyond just the samples themselves. Thesefacilities also need to manage the informationassociated with the samples, such as patientdemographics, consent records, and chain ofcustody — all of which are required to fulfillcomplex sample requests from researchers,protect patient rights and ensure sampleintegrity. To simplify the management of thephysical samples, many biobanks take advantage of the latest instrumentation and automation systems; however, while this is important,it only solves a piece of the puzzle. In order toprovide a best in class service to researchers,biobanks must integrate these tools with, andtake advantage of, the knowledge and datamade available by a Laboratory InformationManagement System (LIMS).Some facilities, like the UK Biobank, havebeen extensively planned from the outset withbuilt-in automation capabilities that facilitatethe large storage capacity and desired retrievalrates, while others are based on an ad-hoc collection of samples in deep-cooled freezers thatrely on manual retrieval methods. In both casesa growing and important consideration fornational, regional and disease-specific biobanksis how they will ensure sample integrity, tracking and auditing.Tracking the demographic and analytical dataassociated with these samples requires leadingedge laboratories to store and provide thespecimen information in an intuitive and timeefficient manner. Biobanks can significantlyaccelerate development by providing users:

www“With its built-in instrument integration, NautilusLIMS has offered significant productivity gainsright from the outset. It has been integrated withour existing robotics, and thus has improved thedata management process considerably.— Thor Gunnar Steinsli, LIMS ManagerHUNT Research Centre and Biobank Better logistical and operational support A more comprehensive understanding of theassociated specimen information Tools that automate timely and error proneprocesses Real time information for faster, moreinformed decisionsThermo Scientific solutions and servicesaddress these needs.Sophisticated tracking of samples is required tomanage biospecimens. Nautilus LIMS enables usersCount on Thermo ScientificNautilus LIMSTo drive life science research and discoveryforward, accurate, compliant and efficientmanagement of biospecimens is critical.Thermo Scientific Nautilus LIMS is specificallydesigned to address the unique challenges ofspecimen collection, tracking, and storage forpharmaceutical discovery and clinical operations, academic and biosciences, researchcenters, medical institutions and contractresearch organizations.Nautilus LIMS not only facilitates data captureand specification management, but it alsofacilitates chain-of-custody and handling assurance requirements. Whether storing or trackingwhole blood, tissue, cellular lysates, DNA, RNA,proteins, etc., Nautilus supports organizationwide inventory control. Nautilus’ web interfaceprovides centralized global access in a secureenvironment. In addition, Nautilus’ built-in,patented graphical workflow utility tool allowsorganizations to easily extend their capabilitiesand tailor the solution to the needs of eachlaboratory’s unique requirements.to graphically locate samples down to their specificfreezer location.Complex Sample ManagementBiobanking studies require pertinent patientinformation to be available for each samplebeing processed to ensure that researcherscan search a particular disease state, race, andage range for targeted studies. Nautilus LIMSprovides a central location where this information can be stored and managed withoutviolating patient confidentiality. It also supportsorganization-wide inventory control so that thebiobanks can easily determine if they have thesamples available to fulfill an order.Furthermore, Nautilus’ configurable laboratoryworkflow allows individual laboratories to tailorthe definitions of samples and parent/childrelationships, along with the extent to whicheach physical item and related informationis tracked by the LIMS. This can include asneeded sample locations, amount tracking,associated testing, patient information, and anyother complex information needed to verify andfill biobank customer requests.3

“The flexibility, adaptability and stabilityof Nautilus LIMS combined with ThermoFisher’s long-established experienceserving the health sciences andpharmaceutical industries made NautilusLIMS the obvious choice for the datamanagement of this massive project.”— LIMS manager, UK BiobankChain of CustodyNautilus’ hierarchical structure also simplifieschain-of-custody for laboratories. The use ofdetailed hierarchical location management,aliquot/derivative and pooled sample tracking,and documented disposition of samples ensurethat no matter what path a sample or aliquottakes in the laboratory, Nautilus has stored itshistory and can identify each user involved inthe process.collect, normalize concentrations, test, and shipsamples. This process can vary and be quitecomplex but Nautilus’ workflows allow eachbiobank to complete the customer request withease. For example, the biobank technician maydecide to send a different sample than whatwas requested (same patient but perhaps asample at a different concentration, differentvolume, etc.).Nautilus’ intuitive web interface aids integrationand interaction with systems throughout theorganization as well as other facilities, includingregulatory agencies and labs. This enables rapidaccess to up-to-the-minute data and information that impacts every phase of the laboratoryprocess.Consent ManagementResearchers need to be able to query the samples storedin the biobanks. Nautilus LIMS web interface enablesthem to make sample requests and track their progress.Request ManagementA biobank is not working optimally if researchers cannot easily search, organize, and requestspecimens from the biobank according to theirresearch needs. Nautilus’ customer-tailored WebAccess capabilities allow the biobank to do thiswith ease. Using the web interface, customersof biobanks will be able to track the progressof their request from creation to fulfillmentwithout ever entering the Nautilus systemdirectly. Once the customer request reaches thebiobank, Nautilus helps users review, approve,4Consent management is an imperative forbiobanks and biorepositories as it determineswhether a user has the authority to check outsamples and what they are permitted to do withthem. Furthermore, a patient can withdraw aconsent and the system must be able to triggerthe destruction of all samples collected fromthat person, including those that are checkedout and in-progress at a customer’s facility. Weunderstand this need and have built-in sampletraceability to allow for accurate decisions ofwhich samples to dispose of or not use basedon approved consent, whether those decisionsare part of a manual or automated process.Nautilus has the ability to store and view theactual consent, along with any restrictions thatmay have been documented.

Instrument Integration andAutomationMany biobanks today use a high level ofautomation and take advantage of the latestadvances in instrumentation to manage theirbiospecimens. Nautilus is designed to simplifyinstrument and automation system integration. Previously disparate systems can now beintegrated to allow for data to be electronicallypassed between them, eliminating manualerror-prone processes and increasing productivity and data reliability. A short learning curve,easy integration and improved automation meanthat standardizing with Nautilus has a rapidreturn on investment and lower total cost ofownership. Laboratories have noted increasesas high as 72% in user-to-IT ratio, 40% in userefficiency and 50% in work samples permonth when standardizing on a single LIMS.Patient demographics and chain of custodyinformation must remain associated with thebiospecimens. Nautilus’ superior plate handlingallows users to manage all aliquots and its hierarchyExtensive Plate ManagementNautilus simplifies plate tracking by definingplate configurations and fill patterns, lettingusers build and format work-action and decision-tree processes against project requirements. Advanced plate handling within Nautilusincludes graphical workflows, plate editors, andbuilt-in integration functionality that enablesincreased throughput and automation. Userscan automate data flow or manipulate it manually, using capabilities like drag-and-drop withina graphical plate editor. Previously disparatesystems can now be integrated to allow fordata to be electronically passed between them,eliminating manual error-prone processes andincreasing productivity and data reliability.Furthermore, Nautilus simplifies printing andscanning of 1D and 2D barcodes.Unifying LIMS and AnalyticalInstrument DataUntil now, LIMS and analytical systems havebeen autonomous and disparate. The DataManager solution in Nautilus moves towardfully integrating these two platforms byproviding the ability to store raw data frominstrumentation and converting this data to aplatform-independent format. By linking thisdata to LIMS entities directly, users can makeinformed decisions since they have access toall of their instrument data in a single interface.Users can compare analyses from disparateinstruments and overlay the results. DataManager bridges the gap, maximizing the valueof existing analytical instruments and protectinginvestments in the future.ensures that sample information is available fromthe biospecimens down to the individual aliquot.5