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


  Order your test sample -50% off (valid until Dec. 31, 2021)  

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 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 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

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 the ISO Technical Standard 20399.

 

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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