The biological samples gathered for clinical research are precious to pharmaceutical clients, and in most cases, irreplaceable. If these samples are compromised at any stage prior to analysis, the study results can be affected and potentially invalidated. Therefore, timely and appropriate handling and storage of these samples, with the ability to track the lifecycle factors for each one, is of paramount importance. So, it should come as no surprise that sample storage in regulated bioanalysis is one of the most critical aspects of clinical trial support.
More than two years ago, as part of long-term planning for construction of a new facility, leaders at Eurofins Viracor BioPharma (EVB) evaluated their sample storage capabilities. They quickly recognised that the existing “farm” of 65 ultra-low temperature (ULT) freezers that are spread across multiple areas of the lab and used on a daily basis was not sustainable. The new facility would need to enable the BioPharma business to expand its storage services with existing customers and to acquire new customers that were looking for a full suite of sample management and storage offerings.
Ultimately, the decision was made to invest in a new system that would meet both clients’ needs and comply with the heightened regulatory requirements that are in effect for the storage of biological samples for clinical trial research. EVB chose the Hamilton BiOS XL4, a fully automated ultralow freezer system (-80°C) with triple redundant cooling, which would provide the ultimate in protection, reliability, operational efficiency, as well as ease of use. Installation of the new biostorage system began in 2022 and became fully operational this year. The new BiOS offers a fully automated record and a traceability system that runs on 21 CFR Part 11 compliant software (including automated barcode reading, full audit trail, and LIMS integration), enabling the team to improve the level of service offered to customers, while also increasing the efficiency of storage operations.
The integration of the BiOS into sample processing also offers a significant competitive advantage in the industry through higher volume storage capacity and sample processing throughput. The increased safety and security that the system offers further enhances EVB’s reputation as experts in the handling of all types of biological samples for pharmaceutical research.