Notice of Completion of US FDA Master File Registration for Ceglu™

Sekisui Chemical Co., Ltd. (President and Representative Director: Keisuke Shimizu; hereinafter "Sekisui Chemical") announces that it has completed registration of Ceglu™, a cell adhesion polymer (chemically synthesized scaffold material) that stably achieves the culturing of stem cells, typified by iPS cells, in the Drug Master File (DMF) of the United States Food and Drug Administration (FDA). Sekisui Chemical has been selling the chemically synthesized scaffold material Ceglu™ with an eye on the industrialization of regenerative medicine and has already launched its culture materials business in the US and Japan. With this registration, Ceglu™ becomes a raw material that can be referenced in the DMF for Investigational New Drug (IND) applications and Biologics License Applications (BLA, etc.) in the fields of regenerative medicine products, cell therapy, and gene therapy (CGT) in the United States.

Significance of this DMF Registration

The DMF is a system for registering detailed information with the FDA regarding the raw materials and manufacturing processes of pharmaceuticals and regenerative medicine products. With this DMF registration, pharmaceutical companies and bio-ventures using Ceglu™ will be able to reference the master file in their own IND and BLA applications, expecting benefits such as:

* Reduction of the burden of explanation to regulatory authorities
* Improved reliability of information regarding quality and safety
* Smoother and faster development and approval processes

Through this registration, it is expected that Ceglu™ will be utilized more widely as a material providing safety, reproducibility, and sustainability, looking ahead from research applications for culturing stem cells like iPS cells to clinical and commercial manufacturing phases. We will accelerate the deployment of the Ceglu™ cell adhesion platform in the US, the world's largest drug discovery market, and contribute to the acceleration of the practical application of regenerative medicine.

Ceglu™ Lineup

About Ceglu™

Ceglu™ is a chemically synthesized polymer that enables the culturing of iPS cells and can be used as a solution to coat the surfaces of various materials. Compared to proteins, it possesses high room-temperature stability and does not require a cold chain*. Furthermore, it does not contain animal components, offering high safety, and has passed safety tests for plastics conforming to the United States Pharmacopeia and the Japanese Pharmacopoeia.

Sekisui Chemical aims to build a consistent cell adhesion platform from the lab scale to the manufacturing scale by providing Ceglu™ coating solution (a coating agent) and Ceglu™ cultureware (pre-coated plates). Past examples of its utilization include differentiation into iPS-derived cardiomyocytes, improvement of cell quality reproducibility through combination with automated culture systems, and scale-up of cell cultures through coating on nonwoven fabrics and microcarriers.

Ceglu™ Product Website: https://www.sekisui-cell.jp/products/ceglu/

*Cold chain: A logistics system that maintains a continuous low temperature during the production, transportation, and consumption processes of perishable foods, pharmaceuticals, etc.

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