CellGenix® GMP TCM

T Cell Medium

CellGenix® GMP TCM is xeno-free medium optimized for cultivation and expansion of T cells with no need to add serum. It generates highly functional CAR-T cells and promotes an early-memory phenotype. It is suitable for static and stirred bioreactor systems and supports the expansion of CD4 and CD8 T cells.

We offer the cytokines and growth-factors needed for optimal growth separately. This gives you the freedom to customize and create your own optimal cytokine mixture.

GMP grade

CellGenix® GMP TCM is produced following applicable GMP guidelines and allows for the safe use in accordance with USP Chapter <1043> and ISO 20399:2022.
Our GMP Media are provided with documented evidence of sterility, activity and stability. In combination with our expert regulatory and technical support this will help simplify your raw material qualification and validation efforts.

Name
CellGenix® GMP T Cell Medium
Quality Grade
GMP
Cell Type
T cells
CellGenix® GMP TCM
volume
format
Order Number
500 ml
bottle
20814-0500
1000 ml
bag
20914-1000

CellGenix® GMP TCM

Features

  • Serum-free and xeno-free medium
  • Generates T cell therapy products with an early-memory T cell phenotype
  • Supports expansion of CD4+ and CD8+ T cells
  • Available in bottles and bags, without cytokines

Application

  • Serum-free expansion and cultivation of T cells
  • Promotes highly functional CAR-T cells
  • Can be used in static and simple stirred bioreactors

CellGenix® GMP Quality Standard

  • High lot-to-lot consistency save time on revalidations
  • Defined media formulation rely on consistent product performance
  • Batch-to-batch quality control ensure the safety of your ATMP
  • Expert regulatory & technical support rely on experience

Read more about our GMP Quality

 

Safe │ GMP Compliant│ Reliable

Technical Details

Osmolality
280-320 (mOsm/kg H2O), determined according to Ph. Eur.
pH
7.2 – 7.5, determined according to Ph. Eur.
Endotoxin
≤ 0.5 EU/ml, determined according to Ph. Eur.
Sterility
Sterility test of the final product, determined according to Ph. Eur.
Mycoplasma
Not detectable, determined according to Ph. Eur.
Functionality assay
Ex vivo-culture of primary human CD3+ T-Cells
Intended use
For further manufacturing use.

Handling Instructions

Shipment

Ambient temperature

Storage & Stability

Store at +2°C to +8°C. Please protect from light.

 

Primary Packaging Details

Medium Bottle

  • Material of bottle: Polyethylene Terephthalate (PET), classified USP Class VI
  • Material of bottle top: High-Density Polyethylene (HDPE), classified USP Class VI

Medium Bag – Flexboy®

  • Material of bag chamber: Ethylene-Vinyl Acetate (EVA) with a core layer of Ethyl Vinyl Alcohol (EVOH) as gas barrier, classified USP Class VI
  • Material of bag tubing: Ethylene-Vinyl Acetate (EVA), Silicone, PVC (DEHP-free, suitable for sterile welding), classified USP Class VI
  • Ports: 1x Male Luer Lock Port 1/8″, 1x Female Luer Lock Port 3/16″ with 1x Clave® Connector, 1x filling port (exclusively used for filling the media into the bag during the manufacturing process)

Documents

Static culture in 96-well U-bottom

Protocol: CD3+ T cells were purified from healthy human donors (n=8; EasySep™ Human T Cell Isolation Kit, Stemcell Technologies)*. Cells were activated with Dynabead Human T-Activator CD3/CD28 (Thermo Fischer) at a ratio of 1:1 bead:cell in CellGenix® GMP TCM or competitor media in the presence of IL-7 and IL-15 (10 ng/ml, Sartorius CellGenix). Media and IL-7 and IL-15 (10 ng/ml, Sartorius CellGenix) were added on day 4 and day 7. Cells were splitted on day 4 and day 7 and harvested on day 9.

*In some experiments, cells were frozen in CellGenix® GMP TCM with 10% DMS after purification and thawed before activation.

Figure 1: T cell expansion with CellGenix® GMP TCM (day 9)

CD3+ T cells purified from human donors (n=8) were activated using anti-CD3/anti-CD28-coupled magnetic beads in CellGenix® GMP TCM or commercially available media for T cell expansion in the presence of IL-7 and IL-15 (10 ng/ml, Sartorius CellGenix).

Figure 2: T cell viability on day 9 of culture
CD3+ T cells were cultivated as described. On day 9 cells were labeled with 7-AAD and viability was determined by flow cytometry. Median and spread of n=8 donors are displayed.

Figure 3: Proportions of CD4and CD8+ T cells
CD3+ T cells were cultivated as described. On day 9 expression of CD4 and CD8 was determined by flow cytometry (n = 8 donors).

Figure 4: Memory phenotype after 9 days expansion in CellGenix® GMP TCM or competitor media
CD3T cells were cultivated as described. On day 9 the expression of memory cell markers was determined by flow cytometry. For each memory T cell subpopulation, the median of n = 8 donors is depicted. TCM, central memory T cell; TSCM, memory stem T cell; TEM, effector memory T cells; TEMRA, terminally differentiated effector T cells.


 

Regulatory Support

We offer expert regulatory support to assist you with your regulatory approval process:

  • Comprehensive documentation (e.g. DMFs, Regulatory Support Files)
  • Outstanding QC support (e.g. extensive stability data)
  • Possibility to audit our production site
  • Detailed batch specific test results on our Certificates of Analysis
  • Change notifications prior to relevant changes

Customized solutions can be provided to meet special compliance needs. Contact our Regulatory Support Team for all your regulatory requests & questions:

Phone:     +49 761 88 88 9-0
Email:      regulatorysupport@cellgenix.com

 

In order to stay up-to-date and help improve regulatory guidance we are actively involved in many of the regulatory initiatives and discussions. We were amongst others actively involved in the discussions for the setup of Ph. Eur. General Chapter 5.2.12 and ISO 20399:2022.

 

Regulatory Resources

  • TSE certificate (available on request)
  • Regulatory Support File (available on request)
  • Request a DMF Letter of Authorization (USA only)

Publications

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