In order to provide the highest level of safety for testing in and treatment of patients, pluripotent cell starting material needs to be produced with high consistency and quality for efficient directed differentiation. Cellartis DEF-CS 500 Xeno-Free GMP-Grade Basal Medium follows stringent production guidelines that ensure the absence of human and animal substances that could harm patients. This medium is the same composition as Cellartis DEF-CS 500 Xeno-Free Culture Medium. However, the medium is manufactured as a quality-assured product in compliance with the "Guide to Good Manufacturing Practice for Medicinal Products" notified by PIC/S. The medium is produced using rigorous manufacturing standards to ensure quality and consistency. All materials are of clinical quality, with traceable production processes. A Drug Master File (DMF) on this product has been registered with the Pharmaceuticals and Medical Devices Agency (PMDA), a Japanese governmental organization.
Cellartis DEF-CS 500 Xeno-Free GMP Grade Basal Medium is a chemically defined basal media that is free from human- and animal-derived components and is used for efficient expansion of undifferentiated human induced pluripotent stem (iPS) cells. Cellartis DEF-CS 500 Xeno-Free GMP Grade Basal Medium is manufactured as a quality-assured product, in compliance with the "Guide to Good Manufacturing Practice for Medicinal Products" notifed by PIC/S.
Overview
Optimized for small- or large-scale production of pluripotent cells for downstream use in clinical research settings
Manufactured as a quality-assured product, according to the guidelines for GMP for investigational products