1084292

CD34+ Cell Enumeration System Suitability

United States Pharmacopeia (USP) Reference Standard

• NACRES: NA.24
• UNSPSC Code: 41116107

Eigenschaften

• grade: pharmaceutical primary standard
• agency: USP
• form: lyophilized
• manufacturer/tradename: USP
• application(s): USP Biologics; pharmaceutical
• format: neat
• storage temp.: −20°C

Beschreibung

General description

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.

This product is provided as delivered and specified by the issuing Pharmacopoeia. All information provided in support of this product, including MSDS and any product information leaflets have been developed and issued under the Authority of the issuing Pharmacopoeia.
For further information and support please go to the website of the issuing Pharmacopoeia.

The USP CD34+ Cell Enumeration System Suitability Reference Standard comprises fixed and lyophilized human leukocytes, erythrocytes, and CD34+ cells derived from mobilized peripheral blood collected by apheresis of a G-CSF mobilized donor.

Application

CD34+ Cell Enumeration System Suitability reference standard intended for use in specified quality tests and assays.

Also, use to prepare system suitability standard solution during flow cytometric enumeration of cd34+ cells.

Additionally, used to assess the reagents and ensures correct gating during data acquisition and analysis, detection, and quantitation of CD34+ HSCs.

Analysis Note

These products are for test and assay use only. They are not meant for administration to humans or animals and cannot be used to diagnose, treat, or cure diseases of any kind.  ​

Other Notes

This product is part of the USP Biologics program.

This product is provided as delivered and specified by the issuing Pharmacopoeia. All information provided in support of this product, including MSDS and any product information leaflets have been developed and issued under the Authority of the issuing Ph

This product is provided as delivered and specified by the issuing Pharmacopoeia. All information provided in support of this product, including MSDS and any product information leaflets have been developed and issued under the Authority of the issuing Pharmacopoeia. For further information and support please go to the website of the issuing Pharmacopoeia. The USP CD34+ Cell Enumeration System Suitability Reference Standard comprises fixed and lyophilized human leukocytes, erythrocytes, and CD34+ cells derived from mobilized peripheral blood collected by apheresis of a G-CSF mobilized donor.

Sicherheitshinweise

• Lagerklasse: 11 - Combustible Solids
• wgk: WGK 2
• flash_point_f: Not applicable
• flash_point_c: Not applicable