EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of ISO 21709 testing. This standard specifies process and quality requirements for biobanking mammalian (including human) cell lines. It describes the requirements for the basic procedures of biobank processing cell lines, such as the creation, retrieval, identification, propagation, preservation, storage, quality control and distribution of cell lines.
This standard can be used by mammalian cell lines used for research and development and by organizations performing biobanking activities, users of biobanks, organizations using peer review and accreditation bodies, and programs.
This standard does not apply to biological materials intended for therapeutic use.
Cell lines have unique properties and behaviors that can change as they continue to be passaged. The original phenotype (eg, expression of specific biomarkers) may be lost or new traits or behavior (eg, tumorigenicity development) may develop. It is important to minimize crossover to preserve the original characteristics present when the cell line was first established.
Other problems may also arise, such as contamination and misidentification with microorganisms or another cell line. Cultures can become contaminated during cell line establishment or later when cultures are passaged. These problems are usually invisible and require special tests to detect.
During the entire cell culture workflow, precautions should be taken to avoid cross-contamination between different samples, e.g. using disposable material whenever possible or using appropriate cleaning procedures between processing of different samples.
The biobank will assess the biological safety level of the cell lines to be processed. Biobank will assess the risk of suffocation based on the number and condition of liquid nitrogen tanks and storage methods and install an oxygen monitor accordingly. The biobank must meet biological safety and security requirements for its facilities to minimize the risk to personnel and the environment from using cell lines.
The biobank should seek to provide a separate area for the storage of duplicated cell lines to prevent loss of collections in an emergency. If the biobank cannot provide a separate alternative space for storage, the biobank should replicate the cell lines and store them in separate liquid nitrogen tanks. If the biobank is unable to replicate all stored cell lines, the biobank should make copies of the relevant cell lines or those that contractual agreements may require.
EUROLAB assists manufacturers with ISO 21709 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.
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EUROLABreporting and certification activities, United Accreditation Foundation (UAF), Turkish Accreditation Agency (TÜRKAK) ve Enterprise Accreditation Foundation (EAF) based on the accreditation provided by the accreditation body. The Enterprise Accreditation Foundation (EAF) accreditation body is also a signatory of the United Nations (UN GLOBAL COMPACT) organization.
