Description
Quantity: 250 mL
Format: Bag - BioProcess Container (BPC)
Unit Size: Each
Serum replacementHuman 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.CTS Immune Cell SR is a defined and robust formulation that can replace supplementation with human serum in several different base media without sacrificing any performance of your cells. It eliminates the time and cost of qualifying human serum, enabling a seamless transition from research to clinical applications.Immune cell qualifiedCTS Immune Cell SR supports equivalent or improved results for multiple immune cell types (T cells, dendritic cells, macrophages), when used at similar concentration as human serum.Closed workflow compatibleCTS Immune Cell SR is available in bottle and bioprocess container formats. The bioprocess container chamber is constructed from Aegis 5-14 film. Versatile connection options allow for integration into your closed process.CTS qualityGibco 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 filingSpecific intended-use statements, full documentation traceability, and 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).
