name
CellGenix® GMP Stem Cell Growth Medium
Quality grade
GMP
Cell Type
Hematopoietic stem cells (HSC)
Cytokine induced killer cells (CIK cells)
Natural killer cells (NK cells)
CellGenix® GMP SCGM
volume
format
Order Number
500 ml
bottle
20802-0500
500 ml
bag
20902-0500
CellGenix® GMP SCGM, w/o phenol red
volume
format
Order Number
500 ml
bottle
20806-0500
500 ml
bag
on request - 20906-0500

CellGenix® GMP SCGM

Features

Application

  • Serum-free cultivation of HSCs
  • Expansion and differentiation of NK cells
  • Expansion and differentiation of CIK cells
  • Generation of retroviral and lentiviral vector-producing cells

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
290-350 (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
Expansion of human CD34+ cells
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: 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

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 20399:2022.

 

Regulatory Resources

Publications

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