Biobank initiatives lead toward service expansion

The Stanford Biobank has launched three significant initiatives that will increase standardization and maximize biospecimen quality while offering services flexible enough to meet the varied needs of human subjects research and clinical trials across the Stanford School of Medicine.

"We are excited to embark upon these projects to ensure we continue to maintain the very highest quality standards and deliver the most robust services possible to the School of Medicine community," stated Senior Associate Dean of Research Dr. Ruth O'Hara.

“We are excited to embark upon these projects to ensure we continue to maintain the very highest quality standards and deliver the most robust services possible to the School of Medicine community,” stated Senior Associate Dean of Research Dr. Ruth O’Hara.

NEW LIMS SYSTEM

The first initiative is the implementation of a new laboratory information management system (LIMS). This system, MBioLIMS, enhances flexibility, data connectivity, searchability, and regulatory compliance. It is highly customizable, and also has the capability to connect to other campus data sources (STARR, REDCap) or directly to laboratory instrumentation for direct data uploads. In addition, the system is FDA 21 CFR Part 11 compliant.

CAP ACCREDITATION

The Biobank team is also seeking to complete the College of American Pathologists (CAP) accreditation. This process will incorporate global and national standards and best practices, verifying that the Biobank meets the most stringent requirements for biospecimen storage and quality. Steps for accreditation include peer review of Biobank documentation and procedures, evaluation of freezers and monitoring systems, assessment of the LIMS, and an on-site inspection. The accreditation process is lengthy, taking a year to complete, and includes continuing review and inspection cycles every two years.

INSTITUTIONAL BIOBANKING

Following accreditation, the Biobank’s next endeavor will be expansion into an institutional biobanking model. While the Biobank now provides storage, LIMS, and logistics services to principal investigators leading human subjects research and clinical trials across the School of Medicine, under an institutional model the Biobank­—in partnership with Stanford Hospitals and Clinics and the Clinical Translational Research Unit (CTRU)—will offer standardized, end-to-end biobanking services, including:

• Broad consent for biobanking human specimens for future research,
• Pathways for specimen collection and processing,
• Throughput to long-term storage, and
• Logistics for getting samples to PIs, service centers, and vendors for assays and data collection.

“These initiatives will result in improved access to high quality, well annotated, human specimens for all levels of research at the School of Medicine,” explains Biobank Director Justin Vincent-Tompkins. “Our team looks forward to better serving the entire Stanford Medicine research enterprise.”

Additional information about the Stanford Biobank can be found here.