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Gibco™ CTS™ AIM-V™ Medium, without phenol red, without antibiotics Non-distribution product as customer accommodation.

The first commercially available serum-free formulation for proliferation and/or manipulation of T cells, dendritic cells, and other primary or immortalized cells

$182.00 - $1226.00

Specifications

Cell Type NK Cells, T Cells, Dendritic Cells
With Additives HSA (Human Serum Albumin)
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Products 2
Catalog Number Mfr. No. Quantity Price Quantity & Availability  
Catalog Number Mfr. No. Quantity Price Quantity & Availability  
A3830801 Non-distribution product as customer accommodation.
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Gibco™
A3830801
1 L
Each for $182.00
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A3830802 Non-distribution product as customer accommodation.
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Gibco™
A3830802
10 L
Each for $1,226.00
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Description

Description

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 *

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 '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 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 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.

Specifications

Specifications

NK Cells, T Cells, Dendritic Cells
HSA (Human Serum Albumin)
SDS
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