ISO 23033 addresses biotechnology analytical methods that provide general requirements for the testing of cellular therapeutic products intended for human use and provides considerations for the characterization of cellular therapeutic products, including approaches to select and design analytical methods that are fit for purpose.
Such considerations can be used to establish critical quality attributes for a cellular therapeutic product.
ISO 23033 applies to cellular starting materials (including those for tissue-engineered products) and intermediates of cellular therapeutic products.
ISO 23033 does not apply to tissues used in transplantation
ISO 23033 on biotechnology analytical methods is useful for-
The emergence of cellular therapeutic products has increased the need for high-quality, robust, and validated measurements for the characterization and testing of products containing cells as active substances. These products are regulated by regional health authorities who evaluate product quality in terms of their quality attributes (QAs) via appropriate biological, physical, and chemical assays (analytical methods).
ISO 23033 guidelines provide a general design fit for purpose analytical methods to measure and assess quality attributes of cellular therapeutic products. And can be used for testing the characterization of cells used in virus, exosome, and antibody production.
The analytical method for biotechnology mentioned in ISO 23033 can be applied to the cellular starting material, intermediates, cell end products, control cells, feeder cells, and cells used in assays (e.g., target cells). It also provides general approaches to understand, minimize, and monitor sources of variability. Acceptable levels of accuracy and precision are guided by the biological implications of the measurement result and the practical limitations of the measurement process.
ISO 23033