Takara Cellartis DEF-CS 500 Xeno-Free GMP Grade Basal Medium

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.

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.

Our long history of quality is now paired with GMP-grade products, bringing an added level of confidence and consistency to our portfolio. Our GMP-grade products are manufactured under rigorous standards to ensure quality and consistency in a GMP Manufacturing Site. Takara constructed the Center for Gene and Cell Processing in 2014. This unique facility has been recognized by the 2016 Facility of the Year Awards (Category Winner: Facility Integration) for its innovative use of facility integration to house cell products, viral vectors, and recombinant proteins within the same facility.

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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
• Rigorous manufacturing standards ensure quality and consistency; all materials are of clinical quality, with traceable production processes

More Information

Please see the product`s Certificate of Analysis for information about storage conditions, product components, and technical specifications. Please see the Kit Components List to determine kit components. Certificates of Analysis and Kit Components Lists are located under the Documents tab.