Gibco™ CTS™ Immune Cell Serum Replacement (SR)

Description

• CTS Immune Cell Serum Replacement (SR) is a defined xeno-free formulation designed to support in vitro expansion of human immune cells when added as a serum substitute to supplement a basal cell culture medium such as Gibco CTS OpTmizer T Cell Expansion SFM or CTS AIM V Medium
• Serum replacement Human serum, a key component in many immune cell culture protocols, is expensive, inherently variable, and requires extensive safety testing prior to use when manufacturing a cGMP-compliant adoptive cell therapy product
• CTS Immune Cell SR was developed to provide a serum-free, xeno-free complete medium that would minimize the supply and safety risks associated with human serum
• This defined and robust formulation can replace supplementation with human serum in several different base media without sacrificing any performance of your cells
• CTS Immune Cell SR eliminates the time and cost of qualifying human serum, enabling a seamless transition from research to clinical applications
• Immune cell qualified CTS Immune Cell SR supports equivalent or improved results for multiple immune cell types, when used at similar concentration as human serum
• Closed workflow compatible CTS Immune Cell SR is available in bioprocess container format
• The chamber is constructed from our highest quality Aegis 5-14 film
• Sterile, weldable C-Flex™ tubing with a female luer lock or MPC quick connect provides versatile connection options for integration into your closed process
• CTS quality Gibco CTS products are manufactured at a site that uses methods and controls that conform to cGMP for medical devices, 21 CFR Part 820
• Our FDA-registered manufacturing sites are ISO 13485-certified
• Gibco CTS products follow USP 'ancillary materials for cell, gene, and tissue-engineered products' within the responsibilities applicable to a supplier.* Accompanied by documentation to support your regulatory filing Specific intended-use statements, full documentation traceability, and convenient access to our Drug Master File (DMF) are available
• *Other aspects of USP will be the responsibility of the end-user to assess
• Thermo Fisher Scientific cannot fulfill USP in regards to application and therapy-specific aspects (e.g., residual assessment and removal of the Ancillary Material).