计数系统适用性试验用CD34+细胞

The CD34+ Cell Enumeration System Suitability standard is designed for assessing the performance of analytical systems used in the enumeration of CD34+ hematopoietic stem and progenitor cells. This USP reference standard ensures accuracy and reproducibility in flow cytometry-based assays, which are crucial for evaluating stem cell doses in transplantation and cell therapy. It provides a consistent benchmark for laboratory systems, validating system suitability and operator performance in cell enumeration workflows.

The United States Pharmacopeia (USP) provides quality standards for biologics to ensure their safety, efficacy, and quality throughout the manufacturing process. These standards assist manufacturers in adhering to regulatory requirements and help safeguard public health by reducing risks associated with biologics.