Kyokuto has established three main pillars in its operations: the clinical microbiology field, the clinical chemistry and immunodiagnostics field, and the cell culture field. In the cell culture field, cell culture applications (e.g., powder medium, liquid medium, cryoprotectant, cytotoxicity assay evaluation kit, and others) have been extensively studied and developed.
Kyokuto has developed cell culture media and related products for over 30 years. We offer to the marketplace culture media for manufacturing biological pharmaceutical drug substances, as well as culture media and reagents for assisted medical care. On the basis of these technologies, we continue to accumulate an unparalleled level of expertise and manufacture medical-purpose products and drug manufacturing culture media.
For nearly 30 years, Kyokuto has made breakthroughs in the manufacture of custom-made culture media, and we continuously strive to meet customers’ expectations. Manufacturing is conducted under a quality management system based on the ISO13485 and ISO9001 standards, with thoroughgoing quality control. Our excellent manufacturing technology capabilities allow us work with a variety of medium compositions (from classic to serum-free media) and customer requirements. With regard to the manufacturing of custom-made culture media, strictly traceable materials equivalent to biological pharmaceutical drug substances are available.
Upon completion, products undergo the following examinations, based on customer requirements: biological testing (sterility tests; bioburden and endotoxin; detection of mycoplasma, yeast, or fungus; specific microorganism tests, etc.), safety tests (arsenic and heavy metals), physical properties (pH, osmotic pressure, moisture content, solubility, etc.), and performance tests (cell culture assay, cellular products assay, etc.).