Cutting edge technologies for
iPSC/ESC culture medium
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 high performance iPSC/ESC culture medium, “StemFit”, for iPSC/ESC research and further clinical applications.
StemFit medium shows high growth performance and enables stable culture 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 schedule simplifies cultivation work and significantly reduces cultivation costs.
Animal-derived components in 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) product for the culture media and growth factors. AOF is recognized as a critical item of ancillary materials* (AMs) for cell therapy products.
Ajinomoto has a high level of technology in the manufacture of AOF products. StemFit media and growth factors are developed and manufactured under strict AOF policy. Ajinomoto's AOF products enable to obtain consistent experimental results and support 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 which are used for cell therapy product manufacturing are categorized in AMs.
Ajinomoto AOF policy
- ・The product does not contain any raw materials from animal or human source, or materials isolated from animal or human source.
- ・The product does not contain any raw materials produced in animal or human derived cell lines.
- ・No animal or human-derived materials except those properly inactivated are used in all production process.
Regulatory compliance for
cell therapy products
The manufacturer of cell therapy products is required to select the media and growth factors which 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 stage of basic research. Switching cost increases drastically as the project moves to the late stage.
Ajinomoto’s AOF products are developed and manufactured in accordance with strict Japanese regulations (Standard for Biological Ingredients, MHLW notification No.210). Ajinomoto has been consulted by Pharmaceuticals and Medical Devices Agency (PMDA*) on material eligibility for cell therapy products. Several AOF products including StemFit Basic03 have been confirmed officially by PMDA to be usable to produce cell therapy products. Furthermore, GMP compliant products** support 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.