[Case Study] Cell Culture Processing Facility (CPF) Compliant with the New Regenerative Medicine Law

Achieving advanced aseptic management! A case where a manufacturing environment for clean rooms compliant with GCTP regulations has been established.

At the research institute, we are advancing the development of therapeutic drugs for diseases in the central nervous system, such as ALS and Parkinson's disease, as well as congenital metabolic disorders. However, for the manufacturing of formulations used after clinical trials, facilities managed under GCTP (Good Cell and Tissue Practice) are required. It is essential that the experimental area for development and the manufacturing area are separated to prevent the mixing of research reagents and materials with manufacturing reagents and materials. Therefore, we constructed the room based on antibacterial panels and antibacterial floor sheets as a cell culture processing facility compliant with GCTP. As a result, the facility has also adapted to the new regenerative medicine law, ensuring very high safety and satisfactory quality control and operational aspects. 【Issues】 ■ There was no manufacturing environment for formulations that could be used after clinical trials. ■ The current laboratory does not manage cleanliness grade. ■ Facilities compliant with GCTP regulations, the Cartagena Act, and guidelines for sterile formulations are necessary. ■ It is essential that the experimental area for development and the manufacturing area are separated. *For more details, please refer to the PDF document or feel free to contact us.

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