Gibco™ CTS™ StemPro™-34 SFM XF Medium

Key benefits for cell and gene therapy applications

• Serum-free and xeno-free—formulated without serum or non-human derived components to comply with global regulatory standards for ancillary materials in cell therapy manufacturing; formulated with L-glutamine and without phenol red
• Supports cell differentiation—facilitates differentiation of induced pluripotent stem cells (iPSCs) to HSCs and further differentiation into immune cells (NK cells, T-cells, B-cells, macrophages, etc.)

Regulatory compliance and quality assurance

• cGMP manufactured—produced in accordance with 21 CFR part 820 and ISO 9001 and ISO 13485 standards to help ensure the highest quality and safety
• USP <1043> compliant—designed to meet USP <1043> standards for ancillary materials used in cell, gene, and tissue-engineered products

Seamless integration with closed system workflows

CTS StemPro-34 SF XenoFree Medium is available in both 500-mL bottle and 2-liter bioprocessing container (BPC) formats, supporting processes through cell therapy development and manufacturing. The BPC chamber is constructed from Aegis 5-14 film and includes sterile, weldable DEHP-free PVC tubing with Luer lock and C-Flex tubing with MPC quick connector. This helps provide versatile connection options, helping ensure maximum sterility and efficiency in your manufacturing process. The 2-L kit format includes both supplement and basal components in BPCs for closed system workflows.

Comprehensive documentation for regulatory support

To facilitate your regulatory submissions, CTS StemPro-34 SF XenoFree Medium comes with an extensive documentation package, including certificates of analysis (COA), access to drug master files (DMFs), and/or regulatory support files (RSFs), and certificates of origin (COO) upon request.

Choose CTS StemPro-34 SF XenoFree Medium for a robust, regulatory-compliant solution that supports the critical processes in cell and gene therapy manufacturing, helping ensure the highest standards of quality and safety.