Safe storage of biological samples is a cornerstone of successful research projects and clinical trials. However, challenges abound in keeping samples safe, properly preserved, and organized. Biorepository companies work with customers to help alleviate some of those concerns, and Clinical Supplies Management (CSM) has spent the last two decades partnering with research groups that want peace of mind when it comes to storing their irreplaceable biological samples.
With customers in pharmaceutical and biotechnology companies and academia, what sets CSM apart is its ability to flexibly respond to customers’ needs, according to Michael Duda, vice president of U.S. Biomedical Management Services. He says this “goes above and beyond moving samples around.” David Fontaine, vice president of sales and marketing at CSM, adds that “CSM has developed innovative strategies and unique solutions that insure sample safety and have resulted in a stellar record in sample management.”
There are many challenges to proper sample storage in laboratories. One of the most common concerns in the biorepository business is maintaining inventory control of samples, with appropriate labeling playing an integral role in the process. If the label is lost, the identity of the sample is also lost, rendering it unusable at a later date. The cold temperatures found in freezers are not always conducive under the most optimum conditions for labels to stick, and a marker can sometimes wipe away.
To overcome this problem, CSM has instituted an overtubing process (placing the sample that is received from the company into another tube) that allows the preservation of the sample and the environment. The outer tube is given a unique barcode, giving each sample a secondary signature that can be recorded and followed. This idea, although seemingly simple, overcomes a common problem and gives the customer peace of mind, continues Fontaine.
Another common problem faced when storing large numbers of samples is keeping samples organized. As Duda states, “It’s as good as being lost if you can’t find it.” CSM has built a system that knows the exact location of every sample and gives an assurance that samples will not be misplaced. That confidence comes from, as Duda explains, building a system for the business by people in the business. CSM has one database, allowing the customer to have a view of their samples and their respective freezers. In addition, a customer is given one point of contact, to simplify and ease communication.
CSM’s dedicated biological sample management (BSM) facilities, which can be found on both sides of the Atlantic, can be used as additional storage for a lab, acting as “an extension of their customers.” Or, they can provide primary storage for biologics. For example, one large pharmaceutical company recently wanted to centralize its storage. It consolidated all of its storage into CSM’s facilities. This was done to alleviate having to duplicate freezers in almost two dozen sites, some of which were not fully utilized and, therefore, were wasting valuable space and energy.
Safety Tops the List
Safety is number one, as CSM understands that biological samples are irreplaceable. It has implemented an efficient backup storage system powered by emergency backup generators.
A full contingency plan is in place in the unlikely event of an emergency. Fluctuating freezer temperatures cause alerts to issue from a robust alarm system that automatically escalates to the facilities team 24/7. Employees undergo training to quickly and efficiently move samples into dedicated backup freezers, and the team is always trying to improve on the efficiency of transfer rates, according to Duda. Also, communication with the customer is paramount, and in the unlikely event that there is an issue, clients are alerted by both an email message and a phone call.
CSM offers storage from room temperature to –190°C (liquid nitrogen, vapor phase) of blood, plasma, urine, feces, tissues, serum, biopsies, cell cultures, paraffin blocks, DNA, and other substances. CSM currently controls roughly 150 freezers in what Fontaine calls their “freezer farm” with approximately 1.8 million stored samples in CSM’s European and U.S. facilities. Fontaine notes that the recent acquisition of CSM by Clinigen will even further extend the company’s global footprint with additional capabilities in the APAC region, in the U.K., and on the African continent.
However, CSM is not only about the storage of biological samples. It has the bandwidth and the experience to manage the entire process from beginning to end, freeing up customers to focus on the larger goals of their research projects, notes Duda.
One example of how CSM partnered with a customer was by innovating a small improvement that made a big difference. In working through the materials needed in a clinical trial, from Phase I through Phase IV, CSM realized that sending supplies in bulk created unnecessary confusion for the health workers, requiring time and energy to be spent sifting through large amounts of tubes and needles. Also, individual kits were not ideal. CSM took a consultative approach, working together with the customer, to find a solution that benefitted the customer. CSM packaged the supplies for three visits in a smaller box, a solution that the customer said made the sampling faster and less complicated.
An example of CSM’s flexibility is illustrated through one customer’s relatively unique request. The customer wanted several freezers to be housed at CSM, instead of taking up the customer’s valuable lab space. So, CSM managed the transfer of the freezers and samples to its BSM facility.
CSM reports that its customers have more money to dedicate to research after consolidating their storage at CSM. On average, CSM estimates that it saves customers about 30–40%, depending on the storage initiatives from the customer. Also, bulk storage allows for greater cost savings. One customer, in Exton, PA, reported saving roughly 50% of its outsourcing costs during the first year.
The complexities that surround careful, safe, and insured sample storage are endless. Biological samples often degrade between the time they are collected and when they are tested. It is therefore crucial to have a storage process in place that preserves sample integrity over time. “CSM innovates to make clinical trials more efficient and reliable with specialized service solutions,” says Duda.