[E-Daily Reporter NA EUN-KYUNG ] Stem cell therapy developer MEDIPOST CO., LTD.(078160)announced on the 18th that it has signed a contract for the contract development and manufacturing (CDMO) of “hiPSC-based mammary gland cell culture medium” with Q-Stem, a company specializing in human induced pluripotent stem cell (hiPSC)-based mammary gland cell platforms.

Under this agreement, MEDIPOST CO., LTD. will establish a production system for the mammary duct cells culture medium developed by Q-Stem and will be responsible for the production and supply of raw materials. This approach leverages the cell culture, mass production, and quality control capabilities that MEDIPOST CO., LTD. has accumulated through the development and production of cell therapies to produce raw materials for an external company.

Human induced pluripotent stem cells (iPSCs) are stem cells created by reprogramming adult somatic cells—such as those from skin or blood—to enable them to differentiate into various cell types. They possess differentiation capabilities similar to those of embryonic stem cells but allow for the use of somatic cells from patients or specific donors, making them the subject of research in various fields, including cell therapies, disease modeling, and new drug development.

In particular, dermal papilla cells are located at the base of hair follicles and play a role in regulating hair growth and the hair follicle cycle. The culture medium produced during the cultivation of dermal papilla cells—which contains growth factors and proteins secreted by the cells—can be used as a raw material for cosmetics and other products.

Q-Stem’s dermal papilla cell culture medium is produced by differentiating human induced pluripotent stem cells into dermal papilla cells and then culturing them. The entire cell differentiation and culture process takes approximately 120 days. Given the need for long-term cell culture, a key challenge in the commercialization process is transitioning the laboratory-scale manufacturing process to a mass production system while maintaining consistent quality across each production batch.

For this project, MEDIPOST CO., LTD. applied manufacturing process scale-up technology to standardize the long-term differentiation and culture process and establish a raw material supply system capable of mass production. In particular, the manufacturing process was designed to minimize quality variations between batches—which can occur as production scale expands—and ensure stable production.

The produced culture medium is managed in accordance with the “Safety Standards for Human Cell and Tissue Culture Media.” MEDIPOST CO., LTD. plans to ship the product after it undergoes quality testing, including physical property tests, sterility testing, mycoplasma negativity testing, foreign virus negativity testing, identification testing, and purity testing.

This production effort also leverages the manufacturing and quality control expertise MEDIPOST CO., LTD. has accumulated through its cell therapy production processes. Based on production facilities and a quality management system that meet Good Manufacturing Practice (GMP) standards, the company plans to provide contract manufacturing services in accordance with the “Regulations on Cosmetic Safety Standards, etc.”

With this contract, MEDIPOST CO., LTD. will expand the production technology it has accumulated through its own cell therapy business to the production of cell-based raw materials for external companies. Since standardizing processes, large-scale culturing, and quality control technologies are necessary to scale up cell technologies from the R&D stage to commercial production, the company plans to leverage these capabilities to expand its CDMO business.

A MEDIPOST CO., LTD. official stated, “We will support Q-System’s production of mammary papilla cell culture medium by leveraging the stem cell production technology and GMP quality control capabilities we have accumulated over the years,” adding, “Having established a system capable of stably mass-producing cell differentiation and culture processes over the long term, we will ensure a stable supply of high-quality cell culture medium and continue to expand our cell-based CDMO business.”