For the Raw Materials Used in Regenerative and Cell Therapy Medicine Do You Have Concerns Like These?

Using GMP-compliant raw materials in regenerative and cell therapy medicine is essential for stabilizing the cell manufacturing process and ensuring consistent quality. However, the compounds required for differentiation induction of human iPS cells vary depending on the target cell type, and multiple compounds are used across different stages of differentiation. Since commercially available GMP-compliant products remain limited, sourcing all the necessary compounds is currently challenging. While it is possible to develop GMP-compliant products tailored to a cell manufacturer's needs, doing so requires substantial time and cost, making it impractical in many cases.

During the research and development stage of regenerative and cell therapy medicine, research-grade materials are often used. However, these materials do not necessarily meet the control and quality standards required of raw materials in the manufacturing process. Consequently, as development approaches clinical application, a gap tends to emerge between the level of quality that cell manufacturers expect for manufacturing-grade raw materials and the quality of the products actually supplied. Closing this gap requires close communication between cell manufacturers and material suppliers, along with detailed, in-depth discussions of the specifications and quality needed for these materials.