The Shinagawa CPF obtained a license for manufacturing specified cell products under the Act on the Safety of Regenerative Medicine. （Facility number: FA3150001)
And obtained a license for manufacturing regenerative medicinal products under the Act on the Pharmaceutical Affairs Law.（License number:13FZ110003)
CPF designed to enable compliance with Japanese, US, and European regulations
Strategically located near Tokyo International Airport, the Shinagawa CPF is equipped to comply with Japanese, US, and European cell processing regulations. In May 2015, the new facility obtained a license to manufacture specified cell products, and is accepting commissions from Ministry of Health, Labour and Welfare (MHLW). The facility also offers processing for all cell and tissue varieties, from regenerative medical product development to commercial production.
Trusted safety management and reliability assurance systems
The Shinagawa CPF’s culturing management and quality assurance systems that build on our expertise and MHLW standards. To ensure the independence of cell processing from inspection, MEDINET’s assurance incorporates clearly operational responsibilities.
MEDINET’s state-of-the-art safety systems control the movements of people and materials to prevent contamination and unauthorized release of technology information.
- Cell Processing
- Office, etc.
- Quality Control 1
- Quality Control 2
- Self Cancer Tissue Depository™
- Technology transfer/Process development
- Logistics and materials storage warehouse, etc.
The facility has multiple secure cell preparation rooms.
Security features include entry and exit checks, video monitoring, and 24-hour status monitoring of cell culture and other facilities.
Risk mitigation includes structural protection and backup systems for power generation, air conditioning, and cell culturing equipment.
Proximity to Tokyo International Airport provides ready transportation
The Shinagawa CPF is located near Tokyo International Airport’s logistics terminal area. Arrangements with courier companies ensure prompt shipping nationwide.
Personnel with advanced regenerative medical technology expertise
MEDINET’s competitive advantage in CDMO is its personnel, who are equipped with extensive experience and skills backed by through training programs. MEDINET can support client development and commercialization of regenerative medicine and cell therapy under one roof.
MEDINET produces many varieties of cell cultures with the utmost attention to safety and quality by cell processing specialists. With an engineer’s mindset and exhaustive training in expert knowledge and techniques, our highly skilled personnel exercise a high level of professional discernment. Supported by our advanced training system, to date more than 180,000 cell cultures have been produced safely and efficiently.
Technology transfer and process development
Through joint development projects at numerous universities, medical institutions, and private enterprises, MEDINET personnel have accumulated extensive experience in establishing and operating cell processing technologies. Through technology transfers and process development built on this expertise, our personnel help create highly efficient, reliable manufacturing environments over short timeframes.
To deliver high-quality, safe specified cell products and regenerative medical products, quality management is critical throughout the entire cycle, from materials procurement to manufacturing, transportation, and marketing. At MEDINET, high reliability and safety are assured by quality assurance systems and independent testing procedures formulated and executed by our quality assurance personnel.
Regenerative medicine and cell therapy are client-specific, including cells used, therapeutic techniques, and objectives (research and clinical trial). MEDINET’s marketing personnel leverage the latest knowledge and information to help clients by proposing and executing treatment strategies that meet specific requirements to benefit patients.