We need human tissues and cells for biomedical research. Muscle tissues, nerve tissues, cell lines, blood cells, stem cells, and more. Biosamples and biomarkers are the core basis for much of the work done in the clinical research industry and proficient Human Biosample Management (HBSM) is necessary to procure reliable biosamples. A constantly evolving subfield of clinical research, many practices fall under Human Biosample Management, including but not limited to proper storage techniques, comparison & verification of documentation for samples’ chains of custody, outsourcing the yielding of values from samples, accounting for discrepancies between database information and sample labelling, as well as legal and ethical biobanking. Some of these practices may align within the same Human Biosample Management structure while others may be natural opposites, but all of these practices are currently trending to some degree because of existing imperatives for their continued use. A closer look at these existing trends in Human Biosample Management may help you decide on your own sample management structure, whether you’re instituting a new structure or making changes to an existing one.
1. Software Integration
Knowing that integrating software into your Human Biosample Management structure is trending is a given. Because software integration has permeated most industries and is actively permeating virtually every major industry in the world that hasn’t yet become fully digitized. Still, it’s good to ask:
- What kind of software solutions are offered for HBSM?
Software integration for Human Biosample Management can help streamline your collection process via barcoded sample labeling, which enables documentation of sample transportation, storage, and availability via simple scanning, automatically updating relevant personnel as to the samples’ status. Software integration also allows for more convenient filling and processing of acquisition forms, requisition forms, e-consent forms, and generally simplifies your paperwork process.
Software Integration in HBSM also accounts for discrepancies between your database and your sample labels and can automate the generation of queries and data clarification forms. It also keeps track of the number of kits necessary for your research project and can streamline the resupply orders for your kits to varying degrees of automation. In highly integrated software systems, your CTMS, lab management software, and HBSM software can all be integrated into a singular seamless system, which can be customized and changed for any and all operational requirements.
2. Sample Backup
While not universally practiced, a trending practice in the world of clinical research is to back up biosamples for important research projects. You don’t particularly need to integrate that into your organization’s process if your project’s samples aren’t too difficult to replace due to extremely specific requirements, but it would still be useful. At best, collecting new samples is an inconvenience and a marginal increase in your cost. However, the most impactful use of Sample Backup becomes apparent when you have narrowly specific biosamples that are not easy to obtain.
Sample Backup is trending in popularity because it’s a relatively easy practice to include in your process. Before deploying collected samples for a project, small portions from those samples are retained as a precautionary measure, to account for any potential destruction or contamination of the originally designated portions of the samples.
Let’s use the easiest example of a sample. Blood. Let’s say a project requires 1 ml portions of blood from multiple existing samples. The samples were collected in 5 ml volumes. 3 ml portions from blood samples could be designated for a particular research project to use and account for possible errors. The 2 ml blood portions remaining from the original sample collection would be retained as a backup. An additional safeguard against problems and errors, in case the 1 ml portions originally required and the extra 2 ml sent out with them are not enough.
The above example of Sample Backup can be applied to most types of sample collection, in a general sense. If the practice of Sample Backup is well integrated into a procedure, you might even find that sample collectors account for it at the very beginning by gathering a little more of their required samples during the collection stage.
3. Automated Biobanking
Automated Biobanking is an approach to radically reduce the manual tasks involved in properly storing, labeling, authenticating, and monitoring samples, as well as increasing the ease of displaying much of their data values and making sample retrieval easier. Automated Biobanking is aimed at improving the consistency behind many of these tasks, as well as reducing any human error factors and sparing the professional staff employed by relevant organizations from the repetitive tasks involved in manual biobanking (pipetting, labeling, etc).
Automated Biobanking also means your professional staff has more bandwidth for other highly specialized tasks for which they are trained, and their attention to these tasks may reduce some of your other costs (such as outsourcing) depending on your Human Biosample Management structure. Of course, a more automated HBSM process also means that as your operations expand, you would need to increase your hires by a smaller number of people than you otherwise would have. New talent for growing organizations will remain an absolute necessity, but the opportunity to reduce costs by automation cannot be overlooked.
4. Specialized Accreditation
While your staff might be highly trained and you may be operating in a jurisdiction that doesn’t require additional accreditation for Human Biosample Management, it might be useful to bridge any potential gaps for newcomers to your team, who may be very experienced in several other areas but new to biobanking and Human Biosample Management. Some organizations are now putting their relevant staff through a specialized accreditation program to ensure a higher standard of training and awareness in the management of biosamples.
Nobody can argue with competence gained through experience, but a standardized process for everyone to refer to as a point of common understanding, much like automated biobanking, allows for greater consistency and reduces the possibility of human error. It’s also important to note that if you’re undertaking HBSM tasks on behalf of another organization as part of an outsourcing contract that you’re likely competing with other providers of outsourcing services. Offering the expertise of your specially accredited staff is a significant asset in that regard.
5. Dedicated Repositories
Rather than buying a suitable freezer to put in one particular laboratory room, or a more advanced cooling system for samples with special requirements, a rising trend in Human Biosample Management amongst organizations affiliated with research nowadays is to build dedicated repositories. Biorepositories. Instead of laboratory staff manually labelling a few samples for their individual projects and then leaving them in a freezer in their laboratories, hoping the power doesn’t go out, or another researcher won’t accidentally contaminate their samples, large and dedicated storage facilities, which are not only equipped to hold biosamples properly, but also to sort them and track them, so that researchers can easily access them for various projects. Biosamples’ chain of custody is clear, starting from their points of origin and up to the rooms and research projects in which they’re utilized.
These storage facilities are not only equipped with the right freezers and more advanced cooling facilities, but also with backup generators to account for power failures, optimized temperature conditions for cell cultures, and of course, a system to easily withdraw samples according to their origins and values. The system may be manual or automated, but it is designed to facilitate sample access for researchers as well as maintain sample integrity.
6. Cost Recovery Fees for Biobanks
There is more than one type of organization that may maintain a biobank. Among them are academic hospitals affiliated with clinical research organizations, large pharmaceutical companies, and scientific research organizations independent from both hospitals and private sector corporations. While the costs associated with private sector biobanks for large pharmaceutical companies are typically covered by their founding corporations, academic, independent, and public sector biobanks typically rely on grant money.
The irregularity of such funding may limit some biobanks in the numbers of dedicated staff which manage them. Such irregularity may also limit system and equipment renovation as well as maintenance options, not to mention the possibilities of enlargement and expansion to accommodate growing research demands. Because some jurisdictions do not allow profiting from the sale of human tissues, and samples from biobanks must often be compatible for use outside their own jurisdictions, the options for biobank revenue are limited.
Typically, this means that biotech startups and smaller corporations that may need access to Human Biosamples typically face more difficulty in obtaining samples from biobanks. These companies are not in the financial position to establish their own biobanks, and they cannot buy Human Biosamples from independent and public sector biobanks. Under this model, the public sector biobanks typically prioritize their own researchers’ needs for Human Biosamples, leaving a narrower array of options for smaller corporations focused on the life sciences.
But a new trend is making changes to this model. A number of independent and public sector biobanks are now charging carefully calculated cost recovery fees to avoid making a profit from selling human tissues. They are also making a profit by offering additional services related to sample processing, such as DNA extraction and cutting sections of genetic material. While this arrangement still grants higher priority to the researchers affiliated with an independent biobank’s organization, it evens the odds for smaller corporations in need of Human Biosamples whilst being without the means of establishing their own biobanks. If the trend progresses with no market hindrances or opposing regulations on a global scale, sourcing Human Biosamples may become more equitable in the future.
These are some of the most important trends and practices in Human Biosample Management today. Human Biosample Management is a rapidly developing aspect of the clinical research field, and no doubt more prominent trends will surface over the next few years. For example, as biotech start ups continue to become more numerous, I find myself reflecting that it may become more common for multiple start ups and smaller corporations to establish biobanks together on a cooperative-like model if the regulations are amenable. Reflecting, not directly predicting. For a rapidly growing subfield of clinical research such as HBSM, the long-term future can be very difficult to predict. Nevertheless, surging trends can offer valuable insight as to the most dominant HBSM practices in the more immediate future.