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International Clinical Trials

Smart Biobanking


The concept of biobanking has triggered massive interest in the area of long-term sample storage conditions, and the key challenge today is maintaining sample integrity. In order to combat this, biobanks are adopting new storage solutions that will guarantee better sample quality to the research community.

Sample storage is an activity outsourced by many large pharmaceutical companies globally. Commercialisation of biobanking activity has forced the providers to adopt tools that are more sophisticated and facilitate sample tracking. Laboratory information management systems (LIMS) have proven to be an essential component in facilitating various biorepository models. It is important to understand the workflow involved in each biobank set up, as this will aid the adoption of automation at certain levels. The uptake of automation is largely seen in cold storage and sample processing stages. Biobanks have indicated a high level of interest in storing plasma and serum, whole blood and cells. For a very long time, freeze-thaw cycles were found to be having a disastrous impact on the quality of samples. This article will focus on innovations in the area of sample storage by the vendor community.

 Market Insight

Researchers handling small quantities of samples are at risk of getting contaminated. Further, maintaining consistency becomes a huge factor when large quantities of samples are processed. Therefore, automated protocols are replacing manual ones.

Interest in dry-state storing and eliminating freeze-thaw cycles causing unwanted intervention of sample quality has brought many patented automated biobanking storage platforms for -20°C and -80°C with a facility to store samples in both microplates and micro-tube format. This ensures continuous monitoring of sample even during picking. The cornerstone of every biorepository lies in the efficiency of its freezer inventory software or the LIMS Solution employed. The key objective is to enable researchers to locate and use biospecimens. Besides tracking the location of the vial of a specific sample, it is important to retrieve the associated additional data such as consent information, demographic information and related regulatory data.

Challenges Associated with Clinical Sample Storage

Primitive methods of storing samples in cryotanks have reported instances of loss of samples. They are either discarded owing to the fact that they become unidentifiable, or due to ‘handling errors’. Sample retrieval processes would be laborious if performed by humans. Loss of ID labels can lead to sample mix-up. Given the fact that no two biobanks function in a similar way, it is tough to generalise a technology platform that is common for biobanks. A lot of custom work is required to suit the workflow processes of a biobank. At the same time, funding and financial maintenance of the biobanking infrastructure becomes harder in the long run.

With time, samples require sophisticated methods of storage. Clinical samples demand a highly integrated set up that involves continuous monitoring of temperatures, along with the associated sample information. An exponential increase in the volume of samples is leading to issues with store capacity and duration. Finding space to accommodate new samples at the given temperature and correct conditions poses a huge problem. Today, the lack of high-quality and clinically annotated samples is seen as a major drawback. There is a need to standardise sample handling and storage protocols globally. With very few standardised quality checking protocols for the preanalytical phase, it can be difficult to compare and share samples, especially when specimen volumes are likely to be high. These issues need to be addressed, as they prove to be a barrier for the development of new treatments.

Many issues associated with the scientific use of biobanking samples are ethical in nature, such as consent, personal integrity, privacy protection, safety of samples and access to data and stored samples. The laws and regulations pertaining to ownership, intellectual property rights and commercialisation discourage the use of resource material. There are also issues pertaining to cross-border shipping of samples, which requires consent from donors. With the sole aim of safeguarding the donor information, biobanking acts in Norway and Sweden allow the analysis of samples, but discourage their long-term storage.

Technology Innovations for Clinical Sample Storage

Biobanks seek solutions that are easy, efficient and are able to provide cost-effective sample management. Traditional methods of storage include storing samples in laboratory freezers at -20ºC, -80ºC and liquid nitrogen, and this process is being largely automated with the help of RFID and the MEMS technology.

On the other hand, recent trends show an increasing preference towards room temperature storage. There are firms developing reagents to stabilise DNA and RNA in order for them to last a long time under ambient temperature; this concept has allowed whole blood samples to be shipped and preserved under room temperature for about three months. Adapting to room temperature storage can yield benefits such as eliminating the need for freezer units and extra storage space. Biomatrica and IntegenX Inc are two such companies that focus on products for ambient nucleic acid storage.

Over time, it becomes tough for biobanks and biorepositories to track and retrieve samples when stored at ultra-low temperatures. Traditional methods of storage involve microplates with barcode readers. In the past, retrieval of a single sample from a microplate meant thawing the entire plate, which affected the freeze-thaw cycles of other samples simultaneously. For this reason, sample storage is now carried out in microtubes and individual vials. Previously, equipment and robotic arms were designed to handle microplates; now, systems are flexible enough to cherry pick individual microtubes. TTP LabTech provides high-capacity storage for automated biobanking at -80ºC; this system is capable of cherry picking a sample within 60 seconds. Hamilton Storage provides a scalable and flexible third-generation automated system for biobanking. Matrical Bioscience provides automated sample storage management and retrieval systems. Most of the storage systems today provide robotic interfaces inside a chilled atmosphere in order to prevent the disturbance of unused samples.

Most of the companies involved in long-term sample storage processes have indicated high use of Thermo Fisher Scientific and Micronic BV’s 2D barcoded tubes. These tubes are permanently laser etched to provide traceability. However, in certain cases, too much frost can hinder readability. For this purpose, RFID and the MEMS technology have been incorporated to enhance tractability, even under frosted conditions. Sysmex Bioscience employs RFID for its product, Icebreaker cryovial, and bluechiip Limited uses the MEMS technology. These advancements provide real-time alerts and a temperature history associated with the sample. It is important that the sample does not undergo a wide temperature variation in a given time period. For storage of tissue samples, Provia Laboratories provides innovative human tissue biospecimen storage containers and kit solutions called Proviasette. These have been designed for efficient storage and tracking, thereby increasing the productivity of tissue biobanks.

Conclusion

A totally integrated system of hardware, software and consumable tools would be the way to ‘smart biobanking’. With many new technologies, biobanks oriented towards the future can retain sample quality/integrity by employing smart and smooth sample handling systems available in the market today.

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Divyaa Ravishankar is a Senior Research Analyst in the European Healthcare Practice at Frost & Sullivan. She has seven years of life sciences expertise, which mainly constitute laboratory and market research. Divyaa also has industry experience covering a broad range of sectors, utilising long-standing working relationships with leading industry participants in areas like clinical diagnostics, pharmaceutical and biotech companies. Divyaa holds an MSc in Biological Sciences from Birla Institute of Technology and Science, Pilani, India.
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Divyaa Ravishankar
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