CellGenix® GMP DC Medium

Dendritic Cell Medium

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

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

Application

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 promising immunotherapeutic approach for treatment of different types of cancer.

 

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

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 Shipment of CellGenix® GMP Media at Ambient Temperatures

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

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 9-0
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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