ISO 20391 Biotechnology - Test for Cell Count

EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of ISO 20391 testing. ISO 20391 defines cell counting terms for biotechnology. Describes counting of cells in suspension (usually cell concentration) and cells adhered to a substrate (area density of cells in general). It provides general counting methods (including total and differential counting and direct and indirect counting), as well as important considerations for method selection, measurement process, and data analysis and reporting.

ISO 20391 is not designed for counting cells while in a tissue section or a matrix of biomaterials.

Cell count (or cell count) is a fundamental metric that broadly influences many aspects of biotechnology, from bioproduction to advanced therapy. The number of cells (or number of discrete cells) is usually expressed as the cell concentration (ie, the number of cells per volume) when in suspension and the areal density of the cells (ie, the number of cells per unit area) when adhered to a surface.

Cell number is critical in evaluating efficacy and efficacy for cell-based therapy. Cell concentration within a bioreactor can serve as a quality assurance measure in cell-based manufacturing processes. Many cell-based bioassays need to be normalized to the cell count of interest to allow for inter-data comparability. This standard defines terms and provides general guidance for the cell count measurement process, including method selection, sample preparation, measurement, qualification and validation, and data analysis and reporting.

Direct cell counting involves recording a signal or a series of signals from each cell. In this context, signals can be electrical (as in impedance), optical (as in fluorescent or colorimetric), or mechanical. The signal can be recorded manually by a user or automatically by a tool. Due to the large number of cells in a typical sample, certain direct cell count methods require dilution of samples. The cell number is then estimated based on a dilution factor.

EUROLAB assists manufacturers with ISO 20391 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.