StemFit
Contributing to the realization of regenerative medicine.
Ajinomoto Health & Nutrition North America, Inc.
StemFit is a brand of culture media for stem cells. StemFit contributes to stem cell research and the advancement of regenerative medicine around the world.
Animal-origin free (AOF) and
Chemically Defined (CD)
Ajinomoto has a high level of technology in the manufacture of AOF products. StemFit media and growth factors are developed and manufactured under strict CD-AOF policy.
Ajinomoto’s CD-AOF products enable us to obtain consistent experimental results and support the development of cell therapy products.
Regulatory compliance for
cell therapy products
Since Ajinomoto follows a strict animal origin free CD-AOF policy, the PMDA has officially confirmed our product’s eligibility for use in clinical cell therapy production (in Japan).
Cutting edge technologies for
iPSC/ESC culture medium
StemFit medium shows high growth performance and enables stable culture of undifferentiated induced pluripotent stem cells (iPSCs) and embryonic stem cells (ESCs), as well as mesenchymal stem cells (MSCs).
StemFit medium also shows high cloning performance and enables efficient single-cell cloning in the process of establishment or genome editing. In addition, an infrequent feeding schedule simplifies cultivation work and significantly reduces cultivation costs.
The stable cultivation of iPSC/ESC requires complicated operations and high cultivation costs, in addition to the high technical skills of the workers. Ajinomoto has advanced technology in the development of culture media for iPSC/ESC through collaboration with the group of Prof. Shinya Yamanaka (CiRA), a Nobel laureate for the discovery of iPSC. We jointly developed a high-performance iPSC/ESC culture medium, “StemFit®”, for iPSC/ESC research and further clinical applications.
StemFit® medium shows high growth performance and enables the stable culturing of undifferentiated iPSC/ESC. StemFit® medium also shows high cloning performance and enables efficient single-cell cloning in the process of establishment or genome editing. In addition, infrequent feeding schedules simplify cultivation work and significantly reduces cultivation costs.
Animal-derived components in the media or growth factors can cause lot-to-lot variations and harmful contamination during the manufacturing process of cell therapy products. To obtain consistent experimental results and ensure the safety of cell therapy products, it is important to select animal-origin free (AOF) culture media and growth factors. AOF is recognized as a critical grade of ancillary materials* (AMs) for cell therapy products.
Ajinomoto has advanced technologies around the manufacturing of AOF products. StemFit® media and growth factors are developed and manufactured under a strict AOF policy. Ajinomoto’s AOF products enable users to obtain consistent experimental results, which thereby supports the development of cell therapy products.
*Ancillary materials (AMs) are described in ISO 20399 or USP<1043> as materials that come into contact with the cellular therapeutic product during the manufacturing process but are not intended to be in the final product. Culture media or growth factors that are used for cell therapy product manufacturing are categorized in AMs.
The manufacturer of cell therapy products is required to select media and growth factors that are in compliance with regulations. For a smooth transition from basic research to clinical research, it is important to use regulatory compliant reagents from the early stages of basic research. The cost to switch reagents increases drastically as the project moves to late-stage development.
Ajinomoto’s AOF products are developed and manufactured in accordance with strict Japanese regulations (Standard for Biological Ingredients, MHLW notification No.210). Ajinomoto has directly consulted the Pharmaceuticals and Medical Devices Agency (PMDA*) on material eligibility for cell therapy products. Several AOF products, including StemFit® Basic03, have been officially confirmed by the PMDA to be usable in cell therapy product production. Furthermore, GMP compliant products** support the further manufacturing of cell therapy products.
*PMDA is the agency responsible for ensuring the safety, efficacy, and quality of pharmaceuticals and medical devices in Japan
**These products are not intended for human use.
StemFit is a brand of culture media for stem cells. StemFit contributes to stem cell research and the advancement of regenerative medicine around the world.
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