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

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

At the research institute, we are advancing the development of therapeutic drugs for difficult diseases in the central nervous system, such as ALS and Parkinson's disease, as well as congenital metabolic disorders. However, the manufacturing of formulations used after clinical trials requires facilities managed under GCTP (Good Cell and Tissue Practice). 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 been 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 have cleanliness grade management. ■ Facilities compliant with GCTP regulations, the Cartagena Act, and guidelines for sterile formulations are necessary. ■ It is a prerequisite 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.

Other clean room equipment and facilitiesMachinery and equipment installation/dismantling/relocation