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>.
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 Dendritic Cell Medium
Quality grade
GMP
Cell Type
Dendritic cells (DC)
CellGenix® GMP DC
volume
format
Order Number
500 ml
bottle
20801-0500
500 ml
bag
20901-0500
1000 ml
bag
20901-1000
CellGenix® GMP DC, w/o phenol red
volume
format
Order Number
500 ml
bottle
20805-0500
500 ml
bag
on request - 20905-0500

CellGenix® GMP DC Medium

Features

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

Application

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

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
260-320 (mOsm/kg H2O), determined according to Ph. Eur.
pH
7.2 – 7.5, determined according to Ph. Eur.
Endotoxin
≤ 1 EU/ml, determined according to Ph. Eur.
Sterility
Sterility test of the final product determined according to Ph. Eur.
Mycoplasma
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

Shipment

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

Storage & Stability

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

Expiry

≥ 6 months from date of shipping. Please refer to CoA for the exact expiry date.

Documents

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

 

Regulatory Resources

Publications