Biobanks, authors Erik Steinfelder, Biobanking Market Development Director at Thermo Fisher Scientific

Could Biobanks Be the Currency for an Innovation Economy? Biobanks have come a long way in the past 30 years. From their tentative origins as little more than freezer farms, storing tissue samples in the event that technology might find a way to elucidate knowledge in the future, biobanks have emerged as rich data repositories. These vast, multi-layered and complex libraries have infinite potential. By storing blood, urine and tissue samples, along with associated genomic and medical data, biobanks provide valuable insight for population studies, as well as disease research, genomics and personalized medicine. Every biobank is unique, but all must fulfill two key purposes: to improve patient healthcare, and drive development and medical breakthroughs. Until now, biobanks have primarily operated as standalone innovation centers, evolving their own methods of best practice to protect and regulate human material storage and use. Now, biobanks are at a turning point. To fulfill their purpose, and ensure their survival, biobanks must take a strategic approach, shedding the siloes of the past and adopting a new role of service provider. By sharing data, embracing technological breakthroughs to protect and track samples, and adopting global standards, biobanks can shift towards a new strategic model – that of a service provider that puts the patient at the center of its long-term strategy and provides researchers with the tools they need to drive drug discovery. Protecting sample quality and integrity Biobank samples are at the very least valuable and in many cases irreplaceable. The first element in a strategic approach is to protect these samples in a safe, secure and well-structured way, while providing easy access and retrieval for researchers. Cryopreservation has always been an essential component of a biobank’s workflow, but recent advances in cold storage have led to new levels of consistency and peace of mind when it comes to storing delicate and valuable samples. Cryostorage with air handling systems and liquid nitrogen injections ensure precise temperature control and uniformity, and even safeguard against power outages. Even living tissue can now be routinely preserved at temperatures as low as -200 °C. Consumables also play a huge role in sample integrity and quality, as well as indexing and retrieval. Cryostorage vials provide the critical first line of defense between the sample and its surrounding environment, and so they must have a tight-sealing mechanism to maintain sample integrity at low temperatures. An effective sealing mechanism reduces the possibility of leaks, and prevents sample loss and concentration changes by minimizing evaporation. As samples are taken in and out of storage, capping and uncapping cycles can introduce wear and tear on vials and cap seals. It is therefore important that the tube and the sealing mechanism are robust enough to withstand this handling process. However, protection is only one-half of the storage story; samples must also be precisely cataloged. By attaching high-quality, two-dimensional barcodes, each sample can be automatically categorized, easily retrievable and read in any environmental condition. These barcodes must last the test of time, remaining readable throughout the lifespan of the sample. Opening the channels for collaboration The second criterion for achieving a strategic approach is to share information through collaboration with other biobanks and the wider research population. Many biobanks were created decades ago as scientists took the initiative to store samples for unknown potential use. Without knowledge, models or data from existing biobanks, owners strove to set their own quality, integrity and access requirements; siloed biobanks are the legacy of these isolated projects. Now, the situation is very different. We know that datasets are of limited use if they cannot be shared, and if biobanks can’t be shown to benefit patients, their very existence comes under threat. With fewer publishable results or attributable discoveries, funding will diminish, and willing donors may become fewer, too – especially if they cannot see the societal benefit of the biobank. Many biobanks are already seeing the benefits of collaboration and the power of data assimilation. The 1 Million Genome project is one such success story. Biobanks across 24 European countries have come together to pledge cross-border, centralized access to a million genomes by 2022. It is hoped that this richer database will provide the knowledge to drive disease prevention campaigns and develop personalized therapies. The recent COVID-19 pandemic has brought researchers and biobanks together in many new and novel ways to collaborate and expedite the discovery of effective therapies and vaccines. The UK-funded Medicines Discovery Catapult (MDC) expanded its BioSamples supply network to create one of the world’s largest virtual biobanks with access to over 1.5 million samples across 330 clinical sites. Recent projects included mapping the spread of new COVID-19 variants as they moved through the UK population. By adopting a collaborative approach, biobanks can better meet the needs of their users, providing the information and access needed to truly expedite novel therapeutic discovery. By expanding this collaboration globally, deeper population understandings can be revealed, and clinical trials can be extrapolated from the US and European focus to more diverse populations. Embracing standardization through regulatory compliance Although sample libraries have evolved to bring us a wealth of information, there has been no regulation regarding the collection, storage and processing of human samples. Biobanks now need to be standardized to demonstrate competence, bring impartiality to quality assurance, and ensure consistent operation that protects biological material and data. authors Erik Steinfelder, A recent report in Nature Biotechnology highlighted this issue, stating that 81% of biomedical researchers are constrained by inadequate quality and quantity of biospecimens, and 80% of companies find it difficult to access material.1 To bring much-needed regulation, ISO 20387 standards were introduced in 2018. Aimed specifically at biobanks, these global requirements set the benchmark for competent, impartial and consistent operation. When researchers select a biobank, they need to have confidence their work can be replicated reliably and by becoming ISO 20387 accredited, biobanks can give a level of impartial credibility to their samples, providing confidence to those using them. To date, only two human tissue biobanks and one US veterinary biobank have become accredited, but it will surely only be a matter of time before this accreditation is widely adopted and, therefore, expected. Biobanks who fail to comply may well be left at a competitive disadvantage. Borrowing knowledge through industry partnership Biobanks are becoming service providers to the pharmaceutical and biotechnology research industry, and many industry specialists can lend their experience and knowledge to help biobank owners reach this goal. By talking with experts who work with academics and those in the pharmaceutical and biotechnology industries, biobank owners can gain a unique insight into the needs of their target audience, as well as a broader understanding of the end-to-end drug discovery process. To employ the most advanced techniques and technology, integrate with other biobanks and comply with the latest regulatory guidelines, biobanks must look outwards. By taking this approach, biobanks can find ways to futureproof their operations against wider political, societal, economic and technological unknowns. This knowledge transfer has been demonstrated during the COVID-19 pandemic as industries with little knowledge of cold storage techniques had to quickly learn and adapt to working in this new way. This is only a taste of the power that true collaboration can bring. As biobanks evolve to become service providers, the patient will be put firmly at the center. By sharing data, implementing the latest technological tools and adopting the latest standards, biobanks can unleash their full power and help to drive drug discovery. The possibilities hidden in these precious repositories are only just being revealed. Reference Nat Biotechnol. 2020;38(1005). doi: 10.1038/s41587-020-0678-x About the authors Erik Steinfelder, Biobanking Market Development Director at Thermo Fisher Scientific Olga Mikhaylova, Director of Product Management at Thermo Fisher Scientific