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Gibco™ CTS™ OpTmizer™ T-Cell Expansion SFM (RUO)

Gibco™ CTS™ OpTmizer™ T-Cell Expansion SFM (RUO)

This Research Use Only product is based on our therapeutic grade CTS AIM V SFM , which is an FDA 510(k) cleared device in the U.S. intended for human ex-vivo tissue and cell culture processing applications.

This Gibco CTS OpTmizer T-Cell Expansion SFM supports the growth and expansion of human T lymphocytes and is for research use only. It is a complete serum-free, xeno-free medium consisting of CTS OpTmizer T-Cell Expansion Basal Medium and CTS OpTmizer T-Cell Expansion Auxiliary Concentrated Medium, which are mixed together prior to use. Supplementation with cytokines per the specific procedure and L-glutamine is necessary and should be done aseptically immediately prior to use of the medium.

• Based on a proven medium

• Supports high-density T cell culture (>3 x 106 CD3+ T cells/mL) in static culture and WAVE Bioreactor systems, including CAR-T cells

• Supports T cell activation using Dynabeads magnetic beads and stimulatory antibody-presenting cell protocols

• Similar phenotype, function, and viability (e.g., cytokine secretion profile) to T cells cultured with conventional human AB serum–supplemented medium

• Supports a T cell phenotype (CD4, CD8, and CD62L) similar to human serum-supplemented medium [1]

• Demonstrates enhanced efficacy and persistence of CART-19 cells when grown in medium supplemented with CTS Immune Cell Serum Replacement (ICSR) medium

Based on a proven medium:

CTS OpTmizer T-Cell Expansion SFM for research use only is based on the same formulation as therapeutic-grade CTS OpTmizer T-Cell Expansion SFM, which is an FDA-cleared medium used in immunotherapy applications in the United States. It is currently used as an ancillary reagent in CAR-T immunotherapy clinical trials.

Demonstrated functional performance and In vivo efficacy:

Cells grown in CTS OpTmizer T-Cell Expansion SFM with or without human serum demonstrate good cytokine production profiles in polyclonally activated T cells. CTS OpTmizer T-Cell Expansion SFM maintains the desired CD8+ CAR-T cell phenotype and the CD62L+ central memory T cell expression. CAR-T cells expanded in CTS OpTmizer T-Cell Expansion SFM and injected into leukemic mouse models demonstrated improved CAR-T cell efficacy with reduced tumor burden out to day 49 compared to competitor media.

GMP manufactured:

The primary manufacturing site for CTS OpTmizer T-Cell Expansion 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, of the regulation. Alternate manufacturing sites are available, providing risk mitigation by helping to ensure security of supply.

Versatility:

CTS OpTmizer T-Cell Expansion SFM has been widely adopted in clinical T cell research applications including the culture of CAR T cells. It works with multiple culture formats, including culture flasks and WAVE Bioreactor systems. CTS OpTmizer T-Cell Expansion SFM was designed to support expansion of cultured human T cells without additional serum supplementation. However, superior performance may be observed when supplemented with either human AB serum or CTS Immune Cell Serum Replacement.