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Biobanking capabilities for clinical trials

By Cerba Research

Biobanking facilities store human biological samples, such as bodily fluid and tissue, for research use to improve knowledge surrounding health and disease, with specimens often retained for several years or indefinitely, for long-term future research.

Various projects are in place globally to recruit large groups of healthy people from across populations, which use samples over time to explore the development of particular illnesses or conditions, and why some individuals suffer from such ailments while others do not.

South African biobanking facilities

BARC South Africa, Cerba’s clinical trials affiliate in SA, has a certified Sample Repository (Biobank) in Johannesburg. The facility launched in October 2009 and is one of the most comprehensive biobanking facilities in the southern hemisphere, designed to store more than seven million clinical samples (6.4 million samples at -80°C; a dedicated ambient storage area and 760,000 specimens in the liquid nitrogen vapour phase) and is integrated into the central laboratory services. Storage conditions include ambient (20°C to 30°C), refrigerated (2°C to 8°C) and frozen (-20°C, -80°C and -196°C).

There are currently approximately 3.2 million clinical trial samples in storage at -80°C and 500,000 peripheral blood mononuclear cell (PBMC) samples in the vapour phase of liquid nitrogen.

Research capabilities

The BARC South Africa biobank is involved in research looking at long-term storage preservation of mycobacteria in various media as part of the TB Quality Assurance Advisory Group. Continual internal auditing is done by the quality assurance officer on all work performed by staff to check for integrity of sample processing, storage and on source data recording, with on-going training and development of all staff as needed.

All samples are 100% quality-assured on entry and before ship-out from the facility. Furthermore, robust methods have been developed for receipt of samples into the biobanking unit, sample processing and storage within biobanking unit and for sample distribution from the biobanking unit. These methods include pre-notification steps, shipment approvals, capturing of shipments and quality control into the laboratory management system, sample issues reported on a specimen discrepancy report (SDR), management of permits (import and export), rapid and accurate retrieval of samples.

All shipping performed adheres to International Air Transport Association (IATA) standards. The biobank can therefore disseminate frozen specimens to destinations worldwide, for further research and development following international guidelines and recommendations. Systems known as Citect Scada (US Food and Drug Administration (FDA) approved) ensure real-time continuous monitoring of the temperature, equipment’s electronic processing systems, liquid detection monitors, acceptable oxygen levels and related equipment failures within the facility, electronically documented with SMS notification via two independent service providers to the standby staff in the event of an error.

Storage facilities for clinical trial samples

Today’s remote research sites can pose a challenge, but ‘Cerba’ means certainty. Through the company’s strategically located, state-of-the-art storage facilities, businesses can avoid the risk of lengthy transport, preserving irreplaceable clinical trial samples.

Cerba Research global storage sites feature shipping performed to IATA standards, dedicated receiving, storage, retrieval and shipment areas, qualified staff and quality control (QC) of all shipments in and out. Furthermore, the sites offer electronic barcoded sample tracking, short and long-term sample storage and temperatures from ambient to 80°C with available liquid nitrogen, while meeting increasingly stringent regulations and research commitments.

Cerba has more than 6,300 associates to implement high-quality healthcare services to patients, physicians and biopharmaceutical companies, guaranteeing that patients benefit from proximity, quality and innovative biology.

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