Contract Development and Manufacturing Service

1. Development of manufacturing methods for cell sheet products and contract manufacturing

Features

EManufacturing of cell sheets with gUpCell®,h CellSeedfs intelligent cell cultureware
ECell sheets are manufactured at CellSeedfs accredited Cell Processing Facility (License number: FA3160008)
EExperienced and skilled cell culturing personnel

(1)@Outline

CellSeed provides services including development and manufacturing primarily of cell sheet products, upon receipt of contracted business from pharmaceutical companies and medical research institutions. The manufacturing methods developed and cell sheet products manufactured are of high quality, provided by cell culturing personnel who have been certified by the Japanese Society for Regenerative Medicine.

(2)@Services

¡ Contract manufacturing of cell sheet products
¡ Development of cell sheet manufacturing methods
¡ Quality management testing of cell sheets, etc.

Service

Manufacturing flow

Manufacturing flow

2DOperational and Application support services

(1)@Outline

The Act on the Safety of Regenerative Medicine enforced in November 2014 stipulates the measures to be implemented by the service provider and the system for approval of the manufacturing processes for specified cell products. CellSeed provides various services to assist in obtainment of the license for the cell processing facility, and in the preparation of the necessary documents to submit for clinical trial notification, applications for government procedures, meetings with regulatory authorities, etc.

(2)@Services

¡ Preparation of application materials to be submitted to the Regulatory Authorities for obtaining license to manufacture specified cell products
¡ Creation of SOPs, Prescribed Rules, and other documentation
¡ Consulting
¡ Assistance with the maintenance and management of machinery and equipment in the Cell Processing Facility, and its management organization
¡ Preparation of documents for other applications, etc.

3. Training and Education in cell culturing technology

(1)@Outline

In our Cell Processing Facility, training and education in the culturing and harvesting of cell sheets are provided, especially for less experienced technicians.

(2)@Services

Services

¡ Cell sheet culturing training
¡ Cell sheet harvesting training, etc.

Contract development flow

Contract development flow

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