Disclaimer: The views and opinions expressed in this article are the author’s own and do not reflect the views of Biobanking.com.
A biobank is an entity that stores high-quality biospecimens along with their clinical data such as demographic information, personal medical history, and lifestyle information. Biobanks also ensure that biological specimens are kept in a controlled environment and guarantee that they are collected complying with ethical and legal regulations. The primary role of biobanks is to provide these high-quality biological specimens to external entities, such as researchers, enabling them to have a better understanding of the disease. The sharing of biospecimens with researchers, in turn, improves health outcomes and personalize medicine by developing highly targeted therapies that minimize or eliminate side effects.
A biobank typically varies in size, scale, and research scope. Biobanks can range from a small laboratory or a single research team collection to large-scale population-wide collections. Whatsoever the size of the biobank is, complete management of samples in real-time, including tracking aliquots, pooled samples, maintaining sample chain of custody, and requesting external researchers to provide samples and to process them, is imperative. Laboratory Information Management System (LIMS) is the best tool to manage laboratory and sample data.
Cloud-based LIMS Solution for Biobanks
Looking at the different factors of LIMS implementation, laboratory data management using a cloud-based LIMS seems to be one of the most viable options, both economically and operationally. A cloud-based LIMS not only helps to manage a large amount of data but also enables secure storage of samples and the associated patient data. A cloud-based LIMS addresses data security concerns by collaborating with trusted cloud service providers. Cloud service providers use several mechanisms, such as two-factor authentication, biometric-controlled locks, video surveillance, and regular access reviews to ensure the physical integrity of their servers where LIMS is hosted. Additionally, the data transmission between the client and the server is SSL/TLS 1.2 and 256-bit encrypted to provide secure access to users. The data stored in the cloud is encrypted as well.
In addition, to secure data management, a cloud-based LIMS provides a centralized system to store high-quality specimen data across multiple physical biobanks through a web-based platform. Besides, providing a centralized system, a LIMS also manages multi-site and user-level access permission, ensuring data privacy. A cloud-based system is fully scalable so it can be extended to cope with continually changing requirements of biobanks.
Cloud-based LIMS eliminates the need to buy, install and upgrade expensive software, or pay large amounts up-front for servers and hardware, and pay salaries to IT personnel. With cloud-based LIMS, it is the responsibility of the LIMS supplier to host the LIMS application and maintain users’ data on a secure cloud server. All hardware and other resources needed for enabling users to access the LIMS application is provided by the LIMS vendor.
There are several cloud-based LIMS solutions available to facilitate biobanking. Here, we highlight a selection of three top cloud-based LIMS for biobanking. Before zeroing in on a cloud-based LIMS, biobanks should analyze their specific requirements and make their own investigations.
CloudLIMS Enterprise is a configurable Software as a Service (SaaS) LIMS System for biobanks enabling them to automate their workflows and enhance efficiency. CloudLIMS Enterprise not only helps manage complete sample life-cycle, including automatic sample accessioning, batch editing or importing of samples, maintaining sample Chain of Custody (CoC), tracking samples via barcodes/RFIDs but also assists in managing complex laboratory operations. It facilitates collaborative studies, sample requisition, and inventory management to measure and record inventories of vital supplies and laboratory equipment. Some of the features are listed below:
- Easily record, store, locate every biological sample in your biobank.
- Track and maintain lineage for aliquots, derivatives, and samples.
- Maintain custodian information for activities such as sample collection, preservation, transportation, transfers, analysis, and final disposition.
- Define and organize a research study, associate samples, attach documents, protocols, reports, and share with your collaborators.
- Streamline sample requests received from within your organization or from external researchers. Accept or reject a request to control access to your samples.
- Retrieve samples from the storage location and package them. Keep track of shipped samples between your clients and collaborators.
- Manage your lab inventory data for vital supplies, reagents, and consumables along with vendor details.
- Based on the user group and user role, restrict unauthorized access to sensitive data and follow regulatory guidelines such as HIPAA and 21 CFR Part 11.
- Keep track of all user activities performed in your lab with a comprehensive audit trail.
Pros: A key advantage of CloudLIMS is its cost-effectiveness because it is offered as SaaS. Additionally, CloudLIMS offers complimentary services such as product hosting, free upgrades, legacy data migration, automatic data backups, besides unlimited training and technical support. CloudLIMS is truly configurable, easy to use, flexible to your specific needs. These services make the product apt for small and medium labs.
Cons: The product is configurable however not customizable. Furthermore, the product is interoperable; however, it may not be able to offer seamless integration with robotics.
Labvantage biobanking solution is pre-configured to address all aspects of biorepository management. Using Labvantage biobanking solution, you can collect, process, store, and distribute well-annotated, high-quality specimens to enable collaboration among researchers while ensuring data security and regulatory compliance. Some of the features are listed below:
- Inventory management of biospecimens and their storage locations.
- Genealogy to track and maintain parent samples, aliquots, derivatives and pooled samples
- Patient consent tracking to track consent restriction to meet ethical and legal requirements
- Chain of custody of sample throughout the sample life-cycle.
- Biospecimen annotations with clinical data
- Collection kits to collect samples
- Role-based access for restricting unauthorized access to patient data and for complying with regulatory requirements.
- Study management to manage studies to ensure compliance with the protocol.
Pros: A key advantage of LabVantage is in its ability to offer customized solutions. With a flexible system along with an experienced professional services team, it can be customized to the workflow requirements and changing business needs. Combined with the ability to integrate with instruments and systems, it helps to automate the tasks, thereby enhancing operational efficiency.
Cons: The Labvantage LIMS is not suitable for small and medium biobanks which may find the features of the product to be extraneous for their needs.
3. Biomed Systems Ltd.
LABA — the Laboratory Assistant and Biobanking Application — is a laboratory information management system for biobanking laboratories that features sample management, reagent management, virtual storage, and a lab diary. It enables the creation of virtual storage facilities, such as tanks, freezers and refrigerators, and localization and quantification of stored material. Some of the features are listed below:
- Creation of virtual storage facilities
- Store material and track stored items by date and user.
- Monitor usage of storage facilities.
- Manage and search reagents in your lab.
- Control quantity and expiry of stored reagents.
- Easy to navigate system to manage patient data and clinical samples.
- Support barcodes labels.
- Support GDPR and FDA 21 CFR Part 11 compliance
- Manage experiments and results.
- Add the unlimited number of analysis to the corresponding experiment.
- Filter experiments by cellular and animal model.
Pros: A key advantage of Biomed Systems Ltd LIMS is its ability to build and maintain storage locations. You can easily locate and pick a sample through the search. With its Lab Diary, an Electronic Laboratory Notebook, you can easily manage your experiments and results suitable for speeding up research.
Cons: Biomed Systems Ltd LIMS specimen tracking is not easy to use and may not be interoperable as it is not clear whether it is possible to interface with third-party systems and instruments.
Specific Factors to Consider For Implementing LIMS in Biobanks
Most of the biobanks use a LIMS for just storing the data because a LIMS system is complex and lacks usability when implementing the features to track laboratory workflows. Therefore, biobanks should consider the following factors when selecting a LIMS.
Data Storage: With the growth of advanced technologies such as proteomics, genomics, and metabolomics, there is an increase in data generated per sample. Managing large volumes of data is a daunting task due to the variation in data formats. Despite technological advances in producing big data, their storage, analysis, and interpretation are still demanding. Hence, there is a need for a LIMS system which can not only store a large volume of heterogeneous data but also can make it easily accessible on demand.
Multi-site and Collaboration: Current research practices involve extensive collaboration among a network of multiple organizations such as biobanks, research institutes, governmental bodies, Contract Research Organizations (CROs). This collaboration is critical in elucidating disease etiology, translational research, and advancing public health and patient care. A LIMS system can facilitate managing and sharing very high volumes of data for efficient collaboration in real-time and simultaneously ensuring ethical compliance.
Customizability and Usability: Looking at the needs of all users, consider a LIMS that is configurable and meets all users’ requirements. A LIMS with a user-friendly interface that allows easy data input and updates by busy researchers and other allied staff is critical. Furthermore, updating the data from remote locations should be possible. In addition to this, lab technicians need simple data entry forms that only capture essential information to register biospecimen data. If data entry forms are complex and inflexible, lab users will either register false data in the system or record part of the information in paper or MS Excel.
Privacy and Security: In addition to meeting the research needs, biobanks have the responsibility towards biospecimen donors such as taking informed consent for sharing biospecimens and ensuring donor privacy. A comprehensive security plan along with an emphasis on privacy concerns, such as informed consent and HIPAA requirements, improves patient trust and encourages sample donation. A LIMS that can manage confidentiality while ensuring a secure Chain of Custody (CoC) and efficient biospecimen distribution among collaborating research institutions is critical.
Maintenance and Associated Costs and Access to Technical Support Services: To improve and automate laboratory workflows, implementation of a LIMS is indispensable. However, besides the license fee of a LIMS, there are several additional costs associated with it, including purchasing hardware, training of laboratory staff, technical support, and LIMS maintenance, post LIMS implementation. Biobanks should consider a LIMS that eliminates the need to manage IT infrastructure, provides training at affordable or no extra cost and offers free functional and technical upgrades.
Additionally, as the number of biospecimens increases, already available LIMS functionality is unable to cope with it due to delayed loading and processing speeds, which is related to the supporting IT infrastructure. Therefore, biobanks should deploy a LIMS infrastructure having the ability to be scaled with the changing requirements.