Gibco™ CTS™ AIM-V™ Medium, without phenol red, without antibiotics, 10 L

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.