Cell processing center (CPC)

A cleanroom facility where cells are cultured and processed for cell therapy, with graded clean areas, air handling and pressure cascades, controlled flows of people and materials, and environmental monitoring. CPC is an industry term. In law, a facility that manufactures specified processed cells for treatments under the Act on the Safety of Regenerative Medicine (Act No. 85 of 2013) is a cell culturing and processing facility. Facilities inside hospitals and clinics notify the authorities or obtain a license, companies in Japan need a license, and facilities outside Japan need accreditation. A site that makes regenerative medical products for marketing under the PMD Act is a manufacturing site subject to GCTP. Ask which regime a partner's CPC works under.