Gibco™ CTS™ Immune Cell Serum Replacement (SR)

Beschreibung

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).