描述

CTS AIM V SFM is supplemented with L-glutamine, streptomycin sulfate, and gentamicin sulfate. Additional supplementation with cytokines per specific procedure is necessary and should be carried out aseptically immediately prior to use.

Features include:
• Used as ancillary reagent in Provenge™ (sipuleucel-T), the first therapeutic cancer vaccine approved by the FDA [1]
• Accommodates multiple culture formats, including culture flasks, WAVE bags, and G-Rex devices
• Supports T-cell activation using Dynabeads magnetic beads and stimulatory antibody- and antigen-presenting cell protocols
• Supports expansion of gene-modified CAR T cells (lentiviral transduction)
• Manufactured in conformity with cGMP for medical devices

Proven use
CTS AIM V SFM for research use only is based on the same formulation as our therapeutic-grade CTS AIM V SFM, which was the first FDA-cleared, therapeutic-grade, commercial SFM in the U.S. used in adoptive immunotherapy applications. CTS AIM V SFM is used as an ancillary reagent in Provenge™ (sipuleucel-T), the first therapeutic cancer vaccine approved by the FDA.

GMP manufactured
The primary manufacturing site for CTS AIM V SFM is FDA-registered and has an ISO13485-certified quality management system. The methods and controls used for the manufacturing are in conformity with current Good Manufacturing Practices for medical devices, 21 CFR Part 820. Alternate manufacturing sites are available, providing risk mitigation by helping to ensure security of supply.

Versatility
CTS AIM V SFM has been widely adopted in clinical research applications including the culture of CAR T, polyclonal T, natural killer, dendritic, and TIL cells. CTS AIM V SFM accommodates multiple culture formats, including culture flasks, WAVE™ bags, and G-Rex™ devices. CTS AIM V SFM was designed to support expansion of cultured human immune cells when supplemented with either human AB serum or CTS Immune Cell SR.

What you get
CTS AIM V SFM is available in a 1-liter bottle for small volume users as well as a 10-liter bag for larger volume users. Full traceability documentation such as Certificate of Origin, Certificate of Analysis, and Drug Master File are available.

1. Madan RA, Gulley JL. Sipuleucel-T: harbinger of a new age of therapeutics for prostate cancer. Expert Rev Vaccines. 2011 Feb;10(2):141-50.

規格

內容及儲存

Store at 2–8°C; protect from light