What is ISO 20391‑2 - Performance of cell counting method in biotechnology about?

ISO 20391 discusses cell counting biotechnology. ISO 20391‑2 is an international standard on quantifying counting method performance in cell counting of biotechnology.

ISO 20391‑2 outlines a method for evaluating aspects of the quality of a cell counting measurement process for a specific cell preparation through a set of quality indicators derived from a dilution series experimental design and statistical analysis.

The quality indicators are based on the repeatability of the measurement and the degree to which the results conform to an ideal proportional response to dilution.

The method under ISO 20391‑2 applies to the total, differential, direct, and indirect cell counting measurement processes provided that the measurement process meets the criteria of the experimental design (e.g., cells are suspended in a solution).

The method under ISO 20391‑2 especially applies in cases where an appropriate reference material to assess accuracy is not readily available.

Note1: Several sector/application-specific international and national standards for cell counting exist. Where applicable, consulting existing standards when operating within their scope can be helpful.

Note 2: The method under ISO 20391‑2 does not directly provide the accuracy of the cell count. It primarily applies to eukaryotic cells.

Who is ISO 20391‑2 - Performance of cell counting method in biotechnology for?

ISO 20391‑2 on cell counting biotechnology is useful for:

Manufactures of biotechnologies
Biotechnology test centers
Regulatory authorities

Why should you use ISO 20391‑2 - Performance of cell counting method in biotechnology?

Cell counting impacts many aspects of biotechnology, from biomanufacturing to medical diagnosis and advanced therapy. The cell count can serve as in-process quality control or be used in decision-making. Cell count is also an important parameter in many cell-based assays, including activity and potency, which is often normalized to the cell count to allow data comparison.

ISO 20391‑2 guidelines assist you with the cell counting measurement process, samples for the experimental design, test sample labeling, and measurement of the test sample for experimental design to quantify counting method performance for cell counting biotechnology. ISO 20391‑2 also provides guidance on Measurement precision, Proportional model fit, Coefficient of determination, Data interpretation, Additional statistical analysis, and quality metrics statistical methods to quantify counting method performance for cell counting biotechnology.

ISO 20391‑2 assist in the validation, evaluation, and verification of cell counting measurement processes in biotechnology to produce reliable results in any laboratory.

BS ISO 20391-2:2019

Biotechnology. Cell counting - Experimental design and statistical analysis to quantify counting method performance

Current

Published:

30 Sep 2019