CellGenix® GMP SCGM

Stem Cell Growth Medium

CellGenix GMP SCGM is an optimized, xeno-free medium used for the serum-free expansion of low numbers of isolated human hematopoietic stem and progenitor cells (HSCs/CD34+ cells). In addition, our SCGM is proved to be highly efficient for the expansion and cultivation of human natural killer cells (NK cells) and human cytokine induced killer cells (CIK cells).

General Information

CellGenix GMP SCGM is widely used for standardized generation of autologous and allogeneic cell therapies using HSCs, NK cells or CIK cells.

We offer the cytokines and growth-factors needed for optimal growth of one of these cell types 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 SCGM 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 include documented evidence of lot specific 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 Stem Cell Growth Medium
Quality grade
Cell Type
Hematopoietic stem cells (HSC)
Cytokine induced killer cells (CIK cells)
Natural killer cells (NK cells)
CellGenix® GMP SCGM
Order Number
500 ml
500 ml
1000 ml
on request - 20902-1000
CellGenix® GMP SCGM, w/o phenol red
Order Number
500 ml
500 ml
on request - 20906-0500

CellGenix® GMP SCGM


  • Serum-free and xeno-free medium
  • Reliable and consistent cultivation of HSCs and NK cells
  • FDA Drug Master File available (on request)
  • Compliant to USP Chapter <1043>


  • 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

290-350 (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
Expansion of human CD34+ cells
Intended use
For clinical ex vivo use. Not intended for human in vivo application.

Handling Instructions


Ambient temperature. Please refer to Technote to learn more about 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