SEKISUI CHEMICAL CO., LTD. (President and Representative Director: Ikusuke Shimizu; hereafter, “SEKISUI CHEMICAL”) hereby announces that it has completed drug master file (DMF) registration for Ceglu™, a cell-adhesive polymer (chemically-defined scaffolds material) for stable stem cell culture and other applications including iPS cells, with the U.S. Food and Drug Administration (FDA). SEKISUI CHEMICAL launched the chemically-defined scaffolds material Ceglu™ with a view toward the industrialization of regenerative medicine and has already embarked on a culture material business in the United States and Japan. With this registration, Ceglu™ has become a raw material that can be referenced for DMFs in investigational new drug (IND) applications as well as manufacturing and sale approval applications (such as biologics license application, or BLA) in the fields of regenerative medicine-related products and cellular and gene therapy (CGT) in the United States.

Significance of DMF registration

  DMF is a system where detailed information regarding the raw materials and manufacturing processes of pharmaceuticals, regenerative medicine, and other such products are registered with the FDA. Through this DMF registration, pharmaceutical companies and bio-ventures using Ceglu™ can reference its master files in their IND applications and BLAs, with the following expected advantages.

    ・Reduces effort of explaining to regulatory authorities
    ・Improves reliability of quality- and safety-related information
    ・Smoothens and accelerates developmental and approval processes

  Through this registration, Ceglu™ is expected to be used as a material offering safety, reproducibility, and sustainability in a wider range of applications, from research into stem cell culture, such as iPS cells, to clinical and commercial manufacturing phases. SEKISUI CHEMICAL will accelerate the expansion of the Ceglu™ cell-adhesion platform in the United States, the world’s largest drug development market, and help accelerate the practical application of regenerative medicine.

Ceglu™ lineup

About Ceglu™

  Ceglu™ is a chemically synthesized polymer that enables the culture of iPS cells and can be solubilized to coat the surfaces of various materials. Compared to proteins, it has high stability at room temperature and does not require a cold chain*. In addition, it does not contain any animal-derived ingredients in its production process and offers high safety. It has passed safety tests for plastics in accordance with the United States Pharmacopeia and the Japanese Pharmacopoeia.

  SEKISUI CHEMICAL provides Ceglu™ coating solution, a coating agent, and Ceglu™ cultureware, pre-coated plates, and aims to establish a consistent cell-adhesion platform from laboratory scale to manufacturing scale. Examples of its application to date include differentiation into iPS cell-derived cardiomyocytes, improved reproducibility of cell quality through combination with automated culture equipment, and scale-up of cell culture through coating of nonwoven fabrics and microcarriers.

Ceglu™ product website: https://www.sekisui-cell.jp/en/products/ceglu/

* Cold chain: A logistics method that keeps fresh food, pharmaceuticals, etc. at low temperatures without interruption throughout the production, transportation, and consumption process.