Recommendations for the evaluation of animal cell cultures as substrates for the manufacture of biological medicinal products and for the haracterization of cell banks

Last updated on 23-8-2019 by Anonymous (non vérifié)

Sci. report, recommendat°, guidance doc., directive, monograph



Cell substrates are cells used to manufacture a biological product. It is well established that cell substrates themselves and events linked to cell growth can affect the characteristics and safety of the resultant biological products. Therefore, a thorough understanding of the characteristics of the cell substrate is essential in order to identify points of concern and to develop a quality control system that addresses those points. Recent advances in the use and quality control of new animal cell substrates, particularly continuous cell lines (CCLs) and insect cells, led to the conclusion…

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