As we enter the era of precision medicine, the biopharma industry’s perception of biobanks is changing. Increasingly, the industry recognizes that biobanks aren’t just sites for the cold storage of tissue samples. No, the industry appreciates that biobanks are data repositories, treasure troves of information. The shift is having an impact on biobanking technology developers.
“Biobanking is the foundation enabling healthcare services to be delivered globally at reasonable costs,” says Carola Schmidt, global director of automated solutions at PerkinElmer. “In the short term, it prepares us for a future where healthcare will move from our current model of reactive treatment of disease symptoms to a proactive healthcare service treating the cause of the symptoms and providing a preventative approach delivering better health outcomes.
“As medical endeavors continue to evolve and tissue storage progresses, storage capacity will continuously increase. Some progressive countries have been storing cord blood in national biobanks for years, while other countries offer it as a commercial service individually. These models are enabling the future of personalized medicine.”
Long-term storage of healthy tissue is a growing area of demand as a result of the aging global population. “The biobanking of healthy tissue, such as embryonic stem cells from cord blood used to regenerate damaged tissue, will become the new standard,” Schmidt elaborates. She adds that new treatment options will continue to be discovered by studying stored disease tissue.
Cell and gene therapy
The growth of the cell and gene therapy sector in recent years has also increased demand for biobanking services. According to Schmidt, demand is likely to keep growing, particularly since cell and gene therapies for cancer and cardiovascular disease show so much promise.
“Commercial cell and gene therapy are impacting large-scale drug discovery through to personalized cancer treatment at an individual level,” she observes. “This field of medicine will grow continuously, further increasing the demand for biobanking capacity.
“According to the WHO, the highest mortality rates globally are attributed to cardiovascular disease, infectious diseases, and cancer. These diseases could be characterized more precisely, and treatments could be selected based on patients’ individual molecular profiles, if physicians could apply the tools of personalized medicine. These tools offer the opportunity to significantly improve treatment efficacy and quality of life.”
She adds that when biobanking advances personalized medicine, it contributes to the minimization of harmful side effects. “Minimizing side effects,” she emphasizes, “is important to our society and provides a significant cost-cutting benefit to the healthcare budget.”
By helping the cell and gene therapy sector grow, biobanks not only promote personalized medicine, they also mobilize internal resources and exercise new powers.
“The commercial cell and gene therapy sector,” says Nicolas Louvet, software product manager, Agilent Technologies, “has energized the opening of biobanks to the outside world with an important focus on building comprehensive supply chains, with each chain supported by a complete chain of custody. In particular, inventory management systems should provide real-time information to customers and assist with good practices in all steps of the workflows.”
Biobanking technologies are changing in line with evolving industry demands. When the term “biobank” first emerged in the mid-1990s,1 it was generally used to describe a collection of human samples in cold storage. The technologies were, in essence, large ultra-low-temperature freezers. Since then, the definition has expanded to refer to technologies used to store a wide range of biological materials from a wide variety of sources.
For example, a 2014 study in the journal Pathobiology pointed out that use of human biomaterials in research as a replacement to animal models has increased demand for storage capacity.2 Responding to this demand, it should be emphasized, isn’t simply a matter of creating space for more samples. The samples themselves are in ever greater demand, given the growth in the drug industry. In other words, both deposits and withdrawals to biobanks are more frequent, and biobank design has evolved accordingly.
“Over the last two decades, sample banking workflows have changed significantly,” Schmidt notes. “Initially, they used manual protocols, which were less standardized and had a higher risk of human error than those used today.
“Modern biobanks use full automation from sample loading to archiving and sample retrieving, without manual intervention. The setups are modular and scalable to meet their needs today and in the future. All storage conditions are documented and fully traceable ensuring long-term sample integrity.”
The automation and digitization of biobanks is also a major focus at Agilent Technologies. The company, says Louvet, sees opportunities to enhance automation and digitization at every stage of a biosample’s “life”—collection, transport, facility processing, and treatment for later analysis. Technologies that he cites include freezers, robotization, and sample monitoring.
Such technologies, Louvet continues, are in keeping with growing regulatory demand for traceability throughout drug development and commercialization, and the industry is already seeing the benefits. “Digital solutions help biobanks shift from managing sample location to managing all the data related to sample quality,” he explains. “Was my sample correctly handled prior to storage? Who manipulated it? How did the freezer temperature change over time? Answering questions such as these can facilitate reliable, compliant material traceability.”
Another key benefit of automated biobanks is cost reduction. Areas where automated biobanks reduce costs include sample storage and the preparation of selected samples for analysis.
Additional cost reductions are related to increases in global biobanking capacity—increases due to both state-funded and private actors, notes Schmidt. According to her, current prices reflect the balance between advances in technology and market demand.
“The cost per sample has significantly decreased, but the price varies based on national regulations,” she continues. “Some countries offer biobanking as a fully government-funded national service; some charge on an individual level; and some charge only for the sample storage. Therefore, there are many different price modules in place globally.”
Louvet also acknowledges the impact automation has had on biobanking costs. However, for him, improvements in the sample storage process are a more significant factor.
“Fundamentally, biobanks’ operational costs are accounted in staff, consumables, and laboratory and storage equipment asset management,” he insists. “Automation, while mainly implemented for sample quality purposes, contributes to labor cost reductions, but major cost reductions are driven by improving processes related to sample storage and distribution.”
The true value of a biological sample is the information it yields under analysis. Traditionally, such information was stored and managed separately from the samples. Partly this was for reasons of capacity—large quantities of data were involved—but also for reasons of security and donor/patient confidentiality.
However, latterly technology advances have enabled biobanks to store samples and data in context, and drug developers are starting to realize substantial benefits. “In addition to the demand for automated storage, the more recent tendency is to move away from the concept of simple biobank toward a real databank,” says Louvet. “More and more content and context related to the sample are digitally stored, resulting in augmented needs for data and metadata management—all focused on improving the overall quality of the biobank that is now more and more controlled by the emergence of regulatory frameworks.”
As biopharma sharpens its focus on personalized medicines and therapies for diseases affecting smaller patient populations, demand for biobanking is likely to increase. Schmidt predicts that biobanks will store samples from more varied tissue types, and that industry’s use of those samples will continue to evolve.
“As we improve tissue collection, storage, retrieval, and use, the scope of biobanking and the need for increased capacity storage will continue to grow,” she declares. “Biobanking will play a significant role in the future of global healthcare by enabling us to develop better treatments targeted to the patient, potentially cure disease with replacement tissues grown from stem cells, offer preventative therapies early in disease, and significantly reduce the financial burden created when we treat advanced diseases with inefficient, nonspecific therapies.” She adds that “the possibility of replacing damaged tissues or whole organs from biobanked samples” would further increase demand.
For Eric Vincent, PhD, senior global product manager, Promega, advances in sequencing technologies that reduce the amount of sample required are likely to affect biobanks.
“Technology used downstream of biobanking has evolved to the point where much less sample is required,” he says. “For instance, next-generation sequencing technologies now exist where whole genome sequencing can be performed with an input sample of less than 10 ng, and where RNA-seq can be performed on a sample of 100 ng to 1 µg. So, the amount of sample that needs to be stored for future accession is likely decreasing, which is good because less sample equals less space and fewer resources.” Vincent adds that informed consent is another area in which the biobanking sector needs to develop.
For Louvet, the biobanking sector has yet to develop common standards and methodologies, which he says will be needed to help biobanking keep pace with the drug industry’s increasingly data-heavy, collaborative approach to product development: “A major unanswered concern for biobanks is the lack of homogeneity in procedures associated with sample processing (especially during collection and transport). We see an increasing demand in facilitating biobanks’ data sharing. Metamodels describing biobank information are being developed with no standard—for now.
“[Standardization] would enable the emergence of virtual biobanks, that is, the bundling of multiple physical biobanks into one searchable database. Semantic technology, ontologies, and common vocabularies would encourage the creation of immense data sets through data analytics and information extraction, ultimately leading to data-intensive eScience research.”
1. Hewitt R, Watson P. Defining biobank. Biopreserv. Biobank. 2013; 11(5): 309–315. DOI: 10.1089/bio.2013.0042.
2. Mackenzie F. Biobanking Trends, Challenges, and Opportunities. Pathobiology 2014; 81: 245–251. DOI: 10.1159/000369825.