Quality of advanced therapy products: requirements of extensively manipulated cell used in cell therapy and bioengineering
DOI:
https://doi.org/10.22239/2317-269X.01048Keywords:
Centro de Processamento Celular, Biotecnologia, Cultivo Primário, Cultura de Células, Controle de QualidadeAbstract
Introduction: Preparations of products for advanced therapies include an extensive manipulation stage of the cell primary culture, which can lead to changes in the final cellular population. Standardization of the technique for obtaining the cellular cultures, in complying with Good Manufacturing Practices (GMP), and carrying out quality controls of process and final product, are essential to ensure patient safety and comparability of clinical outcomes. Objective: The purpose of this study was to identify the most prevalent trials cited in the scientific literature or in health standards applied to the evaluation of the quality of human primary cells, which could be inserted in the routine of the Cell Processing Centers. Method: A survey was carried out of scientific articles and health standards related to cell therapy and associated quality assays. Results: This study showed that the advanced cellular therapy products regulation do not specify the tests that should be used for quality control or, when specified, do not define acceptance or rejection ranges for the products, which makes urgent the discussion of such matter. Conclusions: In this article, we highlight the need to prepare the product in the form of a single batch that should be quality-controlled from samples representative of the whole. In addition, we mention some of the trials that define the quality of the advanced cellular therapy product, detailing the points at which they are to be performed in the flowchart.Downloads
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