CellGenix® GMP DC Medium

Dendritic Cell Medium

CellGenix GMP DC is an optimized, serum-free medium used for the generation of human dendritic cells (DCs). It promotes high yields of mature dendritic cells with the desired phenotype.

General Information

CellGenix GMP DC is optimized for the differentiation of CD14+ monocytes into mature DCs. It is used for the generation of dendritic cell therapies, which represent a new and promising immunotherapeutic approach for treatment of different types of cancer.
We offer the cytokines and growth-factors needed for optimal growth separately. This provides you the freedom to customize and create your own optimal cytokine mixture. To fit different cell and gene therapy manufacturing processes, we conveniently offer our media in both bags and in bottles.

GMP grade

CellGenix GMP DC is produced following all applicable GMP guidelines and allows for the safe use in accordance with USP Chapter <1043> and ISO Technical Standard 20399.
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.

CellGenix® GMP Dendritic Cell Medium
Quality grade
Cell Type
Dendritic cells (DC)
CellGenix® GMP DC
Order Number
500 ml
500 ml
1000 ml
CellGenix® GMP DC, w/o phenol red
Order Number
500 ml
500 ml
on request - 20905-0500

CellGenix® GMP DC Medium


  • Serum-free cell culture conditions
  • Optimized formulation for the generation of DCs
  • FDA Drug Master File available (on request)
  • Compliant to USP Chapter <1043>


  • Differentiation of CD14+ monocytes into DCs
  • Differentiation of CD14+ monocytes into macrophages

CellGenix GMP Quality Standard

  • High lot-to-lot consistency – save time and costs 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

260-320 (mOsm/kg H2O), determined according to Ph. Eur.
7.2 – 7.5, determined according to Ph. Eur.
≤ 1 EU/ml, determined according to Ph. Eur.
Sterility test of the final product determined according to Ph. Eur.
Mycoplasma PCR-test according to Ph. Eur.
Functionality assay
Generation of human dendritic cells from CD14+ monocytes
Intended use
For clinical ex vivo use. Not intended for human in vivo application.

Handling Instructions


Ambient temperature. Please refer to Technote for our shipment validation procedure.

Storage & Stability

Store at +2°C to +8°C. Light protection recommended.


Primary Packaging Details

Medium Bottle

  • Material of bottle: Copolymer PET (Polyethylene Terephthalate), Food Grade Certification
  • Material of bottle top: High-Density Polyethylene (HDPE), Food Grade Certification

Medium Bag – Flexboy®

  • Material: Ethylene-Vinyl Acetate (EVA)
  • Material Tubing: Ethylene-Vinyl Acetate (EVA) + Thermoplastic Elastomers (TPE), Classified USP Class VI
  • Ports: 1x MPC Coupling 1/4″ with Sealing Cap (exclusively used for filling the media into the bag during the manufacturing process); 1x Male Luer Lock Port 1/4″; 1x Female Luer Lock Port 3/16″ with 1x Clave Connector


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 9-302
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 the ISO Technical Standard 20399.


Regulatory Resources