Quality Standards

Cytokines, growth factors and media are commonly used in the processing of cells for therapeutic applications. These so called ancillary reagents are not intended to be part of the final product. However, the quality of these products is crucial for the quality of the finished therapeutic product. Regulatory agencies are developing guidelines that outline general risk-mitigation strategies and qualification programs which can be used to select appropriate

reagents (like United States Pharmacopeia, USP General Chapter <1043> “ancillary materials for cell, gene, and tissue-engineered products”) or which outline specific quality attributes for cytokines and growth factors (like USP Chapter <92> “growth factors and cytokines used in cell therapy manufacturing”). CellGenix' quality management system is also certified on the ISO 9001:2008 standards.

To minimize concerns about safety, transmissible spongiform encephalopathies, and other contaminations, animal-derived component-free (ADCF) raw materials are increasingly employed also in the manufacturing of ancillary reagents. The use of GMP grade and ADCF ancillary reagents will significantly reduce qualification and validation efforts of manufacturers and help to ensure consistency, safety and purity of the final cell therapy products.