CellGenix® GMP SCGM Medium

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>.

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.

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
1000 ml
bag
on request - 20902-1000
5000 ml
bag
on request - 20902-5000
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 Medium

Features

  • 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>

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 to learn more about 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

CellGro,

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