CTS AIM-V MEDIUM MINUS 10L，A3830802，Invitrogen

CTS AIM-V Medium is the first commercially available serum-free formulation for proliferation and/or manipulation of T cells, dendritic cells, and other primary or immortalized cells. CTS AIM-V Medium is an FDA-cleared class-II medical device that is intended for human ex-vivo tissue and cell culture processing applications and is manufactured in compliance with cGMP. It contains L-glutamine and is formulated without phenol red and without antibiotics. 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
• Cleared by FDA for human ex-vivo tissue and cell culture processing applications
• 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>*

Security of supply
CTS AIM-V Medium is a defined serum-free formulation that contains no bovine-derived components at the primary component level. The product can be scaled 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- and ISO 9001–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. CTS AIM-V Medium supports expansion of T cells, T cell subsets, and virus-specific T cells. CTS AIM-V Medium can also be used to support natural killer cells combined with feeders. Each lot of CTS AIM-V Medium is pre-qualified using Jurkat cells, an immortalized human T lymphocyte line, to help ensure consistent performance.

What you get
CTS AIM-V Medium is available with 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. For convenience, CTS AIM-V Medium is available in a 1000-mL bottle for small volume users as well as a 10-L bag for larger volume users interested in closed systems.

*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.