Automation as a Tool for Standardizing Biobank Processes

Biobanks have evolved from mere repositories of biological samples to crucial pillars of clinical research and personalized medicine. Automation is at the heart of this evolution and promises to enhance operations efficiency while ensuring the quality of samples and data.

The importance of standardizing biobank processes

Differences in sample collection protocols, inconsistent processing, or variations in temperature during storage compromise the accuracy and reproducibility of biomedical research. Addressing these inconsistencies through standardization, harmonization, and quality control measures helps avoid negative impacts on patient outcomes and costs associated with repeated experiments.

The introduction of standards like ISO 20387:2018, which focuses on competence, impartiality, and consistency in biobanking operations, has been an important milestone for harmonizing procedures at the international level. These standards build a robust foundation for groundbreaking research and therapeutic discoveries through biobanking.

To further enhance precision and consistency, biobanks are increasingly adopting automation.

The benefits and challenges of adopting automation in biobanking

Automated systems reduce human error, improve workflow processes, and increase accuracy and consistency in sample handling, all crucial for maintaining high-quality standards. These systems also enhance scalability, reduce contamination risks, and increase time efficiency in biobanking operations. Additionally, automation ensures comprehensive documentation and traceability of samples, which is essential for quality assurance and regulatory compliance. 

Despite these benefits, hospitals, research centers, pharmaceutical companies, and patient advocacy organizations must consider the challenges of implementing automation in biobanking. These include ensuring the compatibility of devices across facilities and the significant costs associated with the initial equipment purchase and installation. Moreover, although automation might save on personnel, those operating the systems must be trained and, in the case of new developments and innovations, retrained.

Processes that can be automated

Most preanalytical procedures, especially those involving liquid samples, can be efficiently automated. However, specific steps in tissue biobanking, such as the initial tissue sampling and its subsequent partitioning, typically require manual handling, except in cases where robot-assisted surgical techniques are employed.

Automation of transport

Automating the transport of biological samples from collection points or preanalytical labs to the central biobank offers significant improvements over manual handling. This includes 24/7 availability and faster delivery times without excessive personnel costs. 

Specific pneumatic tube systems, e.g., Starstedt’s Tempus600 transport system for individual samples, connect outpatient clinics and wards directly to biobanks or routine labs. These systems are designed to control factors like temperature and handling during transit, ensuring sample integrity upon arrival.

Automated sample processing

Systems from Tecan, Hamilton, Cryo Bio System, and Sarstedt automate the aliquotation process, ensuring consistent processing and reducing the risk of sample contamination. Some robots can even detect different phases in biological samples (e.g., serum/plasma, buffy coat, and/or red blood cells) and separate them automatically during the aliquoting process. 

Technologies are also available for isolating nucleic acids. Different methods—from magnetic beads-based to centrifugation precipitation—are available, each varying in capacity and manual interaction.

Automated storage

Automating the biospecimen storage and retrieval process reduces the exposure of samples to temperature variation and is, therefore, an efficient option to preserve the sample quality.

The experience of the University Hospitals and the Catholic University of Leuven Biobank (UZ KU Leuven, Belgium) in implementing automated sample storage systems illustrates both the challenges and benefits of automation in biobanking. The biobank, established in 2008, aimed to centralize the storage of human biological material for research. In December 2013, they embarked on integrating two automated storage systems from Azenta Life Sciences for different temperature settings: SampleStore (-20°C) and the BioStore (-80°C). 

It took them about four years to fully operationalize the system due to changes in labware, issues with the initial installation quality, no specific guidelines or validation procedures available, and misunderstandings regarding biobank requirements.

Despite these challenges, the team successfully implemented the system. Within 15 months of integrating it into the biobank workflow, they stored more than 63,000 samples in the systems, and significantly reduced hands-on sample handling and retrieval times. With the successful implementation of automated frozen sample storage systems, the centralized UZ KU Leuven Biobank can now efficiently support large-scale translational research.

Interoperability in automated biobanks

Pooling samples and data from multiple biobanks is often necessary to achieve statistical significance in research. Consequently, interoperability in automated biobanks becomes essential. Interoperability is the capacity of diverse biobanking systems and technologies to work together seamlessly. Achieving this involves synchronizing hardware, software, data formats, and storage methods across various platforms.

However, given the multitude of active biobanks and research infrastructures, it is most likely that any such integration would not comprise a single, uniform approach. The integration process can vary based on factors like heterogeneity levels in biobank systems, the regulatory landscape, and the economic impact of the necessary changes.

To address these challenges and achieve interoperability in automated biobanks, consider these tips:

• Actively work toward standardizing data formats within biobanks. This could involve adopting widely used data standards or protocols for easy exchange and analysis.
• When purchasing new equipment, prioritize those capable of interfacing with various manufacturers’ systems. This approach ensures smoother sample processing and transfer.
• Implement software that can integrate data from various sources, providing a comprehensive view of the biobanking process.
• Design your systems to be scalable and adaptable. This means choosing solutions that can grow and evolve with your biobank's changing needs.
• Ensure that all integrated systems adhere to relevant standards and regulations.

The future of biobanking

Implementing automated systems in biobanking, while challenging, offers a long-term benefit that extends beyond operational efficiency. These systems are essential for maintaining the reliability and success of research initiatives.

As biobanks expand in size and complexity, automation will become ever more important. The future of biobanking relies on developing robust infrastructures that can scale to meet healthcare needs and integrate with new technologies. 

The continuous advancement and improvement of healthcare services, supported by sophisticated biobanking infrastructures, are key to advancing medical research and enhancing patient care.