Ceglu™ cultureware performs equivalently to protein matrix in iPSC culture, maintaining both pluripotency and undifferentiated state

The uniform culture surface of Ceglu™ cultureware has been confirmed through atomic force microscopy (AFM).

This feature enables stable cell culture with high reproducibility. The comparison below illustrates two experimental systems: one in which a protein matrix was manually coated onto plate and cultured by skilled technicians, and another using Ceglu™ cultureware pre-coated with the matrix combined with automated medium exchange. As a result, experiments integrating Ceglu™ with an automated culture system significantly reduced variability in the doubling time of iPSCs.

For details please refer to the application note “Reproducible automated iPSCs culture using Ceglu™”.

Typically, culturing iPSCs and differentiated cells requires coating culture vessels with a protein matrix. Ceglu™ eliminates this step, enabling a simplified and more efficient cell culture workflow.

iPSCs cultured on Ceglu™ can be differentiated into a wide range of cell while maintaining a consistent, chemically defined matrix environment.

[Example] Three-germ layer, Cardiomyocytes, Hematopoietic progenitor cells, Monocytes, Hepatoblasts, Neural progenitor cells, Neurons (Dopaminergic neural progenitor cells), Glial cells (Astrocytes), etc.

For details, please refer to the differentiation application note.

・Generation of iPSCs using Ceglu™

・Reproducible automated iPSCs culture using Ceglu™

・Differentiation of iPSCs into all three germ layers on Ceglu™

・Differentiation of iPSCs into neural progenitor cells and astrocytes using Ceglu™

・Differentiation of iPSCs into cardiomyocyte using Ceglu™

・Differentiation of iPSCs into hematopoietic progenitor cells and monocyte using Ceglu™

・User guide

・User guide plus (acclimation)

・Product information (multiwell plate, 6-well)

・Product information (multiwell plate, 96-well)

・Product information (dish, 100mm)

・Ceglu Flyer 

SEKISUI CHEMICAL CO., LTD. announces the successful registration of Ceglu^TM, a chemically synthesized polymer that enables the culture of iPS cells and can be solubilized to coat the surfaces of various materials, with the U.S. Food and Drug Administration (FDA) Drug Master File (DMF)*¹.

With this DMF registration, pharmaceutical companies and biotechnology ventures using Ceglu^TM will be able to reference the registered master file in their own Investigational New Drug (IND) applications and Biologics License Applications (BLA). This is expected to deliver the following benefits:

• Reduced regulatory documentation burden
• Enhanced reliability of quality and safety-related information
• Smoother and faster development and regulatory approval processes

*¹ Drug Master File (DMF) system
A Drug Master File (DMF) is a system under which manufacturers voluntarily submit confidential information related to quality - such as raw materials, excipients, and manufacturing processes—to the U.S. Food and Drug Administration (FDA).
When companies developing and manufacturing regenerative medicine products submit applications to the FDA, they are required to provide detailed information on drug substances (APIs). By registering such information in a DMF, our company can help simplify the procedures required for regulatory submissions.

A chemically-defined plastic scaffold for the xeno-free production of human pluripotent stem cells
Scientific Reports. 2022 Feb 15;12(1):2516.
https://doi.org/10.1038/s41598-022-06356-8

Adhesion Characteristics of Human Pancreatic Islets, Duct Epithelial Cells, and Acinar Cells to a Polymer Scaffold
Cell Transplantation. 2022 Sep;31:09636897221120500.
https://doi.org/10.1177/09636897221120500

Improved Production of Induced Pluripotent Stem Cells Using Dot Pattern Culture Plates
Tissue Engineering Part C: Methods. 2023 Sep 1;29(9):410-23.
https://doi.org/10.1089/ten.tec.2023.0068

Size control of induced pluripotent stem cells colonies in two-dimensional culture for differentiation into functional monocyte-like cells
Cytotherapy. 2023 Dec 1;25(12):1338-48.
https://doi.org/10.1016/j.jcyt.2023.08.002