Gibco™ CTS™ AIM-V™ Medium, without phenol red, without antibiotics

Description

• Gibco Cell Therapy Systems (CTS) AIM-V Medium is the first commercially available, defined, serum-free medium (SFM) for the proliferation and/or manipulation of T cells and dendritic cells manufactured in compliance with cGMP
• It contains L-glutamine, but phenol red, gentamicin sulfate, and streptomycin sulfate have been removed to meet global regulatory requirements for ancillary materials used in cell therapy manufacturing
• CTS AIM-V Medium can be supplemented with human AB serum or CTS Immune Cell SR and various cytokines or growth factors depending on the application
• cGMP manufactured in compliance with 21 CFR part 820 Supports expansion of human peripheral blood T-cells including CAR T cells Supports expansion of activated human dendritic cells and other immune cells Proven clinical use as an ancillary reagent in Provenge™ (sipuleucel-T), the first therapeutic cancer vaccine approved by the FDA (1) Adherence to supplier-related responsibilities of USP <1043>* Closed systems compatible For convenience, CTS AIM-V Medium is available in three formats: a 1000-mL bottle for small volume users, a 10-L bag for larger volume users, and a 2-L bioprocess container designed for users interested in a closed system workflow
• The BPC chamber is constructed from Aegis 5-14 film and includes sterile, weldable DEPH-free PVC tubing with Luer lock and C-Flex™ tubing with MPC quick connector providing versatile connection options for your manufacturing process
• Security of supply CTS AIM-V Medium is a defined serum-free formulation and can be manufactured at scale required to meet future clinical and commercial demand
• Alternate manufacturing sites are available as further risk mitigation
• 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 <1043> '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
• Immune cell applications CTS AIM-V Medium is cited in many peer-reviewed journals and used in multiple immune cell clinical applications such as activated dendritic cells
• It supports expansion of T cells, T cell subsets, and virus-specific T cells
• The medium can also be used to support natural killer cells combined with feeders
• Each lot of CTS AIM-V SFM is pre-qualified using Jurkat cells, an immortalized human T lymphocyte line, to help ensure consistent performance
• *Other aspects of USP <1043> will be the responsibility of the end-user to assess
• Thermo Fisher Scientific cannot fulfill USP <1043> in regards to application and therapy-specific aspects (e.g., residual assessment and removal of the AM)
• 1
• Madan RA, Gulley JL
• Sipuleucel-T: harbinger of a new age of therapeutics for prostate cancer
• Expert Rev Vaccines
• 2011 10(2):141-50.