Biobanking: The Case for Automation

Of the low-temperature strategies for preserving chemical, biological, and medical samples, biobanking is arguably the most critical. A recent report estimates global markets for biobanking equipment and services at around $66 billion, which is expected to grow by six percent per year through 2028. The study cited regenerative medicine, personalized medicine, and "cancer studies" as the primary drivers.

"The expansion in biobanking is a consequence of these advanced therapies, of course, but the need extends throughout the value chain for biological products, and includes research materials, intermediates, and clinical trial materials,” says David Lewandowski, Director of Business Development for Cell and Gene Therapy at Brooks Life Sciences. “Ultimately the drivers are quality and reproducibility."

Cell-based research has come under fire in recent decades for lacking those very qualities. The main issue has been cell line authentication but improperly stored cells and tissues, even those that have been rigorously authenticated, can lead to spurious results. Thus, the scramble for biobanking products and services.

Unlike the much publicized but largely unrealized capacity crunch in monoclonal antibody manufacturing of 15 years ago, this shortage is real, Lewandowski says. "If you're a cell or gene therapy sponsor, needing to source viral vectors, for example, you’ve likely faced some supply chain challenges." Research groups have begun to turn to academic labs with cGMP biobanking capabilities." Particularly relevant to this topic today, Lewandowski notes that COVID-19 "knocked everything back by a year."

With biobanking the issue is not physical volume, for example not having enough 100,000-liter fermenters or 10,000 square foot production suites. Biobanking is more of an intensive activity than an extensive one—think pressure versus volume in gas handling. Finally, while biomanufacturing is a process involving the scheduling of many discrete steps, "banking" is a static activity, which raises the question of why automation is required in the first place.

For Lewandowski the answer is obvious: Consistency, and the need for more of it given the high demand. "Everywhere we see the need for very precise work, but at the same time there is a shortage of personnel needed to execute critical biobanking, whose skills and best practices apply beyond the research lab.” Even within this consistency paradigm, the biobanking industry is evolving. "Next-generation biobanks are no longer established strictly for long-term archival. The best biobanks in the world boast about their data access and utilization rates—and it's not just about collecting freezers."

More mundane factors also affect the decision to automate. As we have seen in pipetting, sample collection, and other routine tasks, workers eventually tire of the repetitive work involved in maintaining frozen collections. Temperature excursions due to freezer door openings or power blips are unavoidable, but automation eliminates mistakes like leaving one sample on a lab bench at ambient temperature while searching for another sample.

"Maintaining a biobank is detailed work, which requires detailed planning and training,” Lewandowski explains. “The manual approach eventually becomes expensive and unreliable in more regulated settings where critical quality attributes are traced. Automation eliminates these variables, and obviates the need to rely on a worker with specific training."

Planning, resource allocation

The demand for resources to support emerging cell and gene therapies exerts evolutionary pressure on biobanking. "In the early days, the focus was on the sample, whereas in recent years the focus is more on the data," says Erik Steinfelder, Biobanking Market Development Director at Thermo Fisher Scientific. "However, data provenance is not always clear, and the data quality differs significantly per institute or region."

Commercial data management is available from Thermo Fisher and other suppliers but some labs, especially in academia, prefer in-house solutions or hybrid systems incorporating open-source software, both of which are more affordable. These solutions may not be sustainable, Steinfelder says. "With increasing demand for proof that samples were stored reliably, connectivity and monitoring come into play. At that level home-grown solutions are hard to maintain, as the required updates and upgrades require too many resources."

Steinfelder notes that even as demand for automated storage increases, the "business case" for it is unclear. "Estimations of sample throughput are often too optimistic, and automation does not address the root causes of quality issues. Data provenance is becoming more and more a focus point and is now also being worked on within ISO because data quality must be improved."

Steinfelder makes the point, however, that biobanking itself "is a process." He cites throughput, the need for efficiency, and connectivity, which together streamline biobanking, improve quality, make it easier to monitor, and facilitate automated decision-making. "And sometimes it's just hard to find qualified staff."

"Biobanking requires planning and budgeting that should include both the automation and the advantages or disadvantages of using it," Steinfelder says. "Too often, one part of the process is defined very strictly and budgeted, while data management gets the leftovers. This approach will not work long-term."

"In biobanking, sample integrity and tracking are critical," adds Melanie Vig, Product Manager-Configurable Platforms, Laboratory Automation, Thermo Fisher Scientific. "Biobanking is evolving from simple sample repositories to complex and dynamic infrastructure networks. The field is most definitely expanding as cell and gene therapy, personalized medicine, and population/consumer genetics grow."

Adapting and evolving

History tends to repeat as biomanufacturing trends evolve from concept to test to deployment. "Drug screening was once completely manual but today, high-throughput automated prep of assay-ready plates is the norm," Lewandowski tells Biocompare. "We are at the same stage, with the need for biobanking, as we were in drug discovery when HTS was just becoming available. It's exciting to see how biobanking, which in the past mostly supported research, is adapting and evolving for new clinical materials and workflows, and that clinical products from these efforts are on the verge of realization."

Cord blood biobanking

With the concern over impending health crises and "emerging" therapies, it's easy to forget some of the established biobanking markets, for example in pathology and stem cell treatments. Cord blood storage is now priced below $600, and this market now valued at more than $10 billion annually. Since stem cells derived from cord blood match donors perfectly, this biobanking application could profoundly and positively affect demand for future gene- and stem cell-based therapies.

"Since these biobanking samples are meant to be stored for twenty-plus years, sample integrity and ID are highly important and must be traceable at all times," says Carola Schmidt, Global Director of Automated Solutions at Revvity. Additionally, the storage conditions need to be continually monitored, with fully automated sample retrieval."