CellGenix® rh GM-CSF

GMP and Preclinical grade

CellGenix Recombinant Human GM-CSF reliably supports the differentiation of CD14+ monocytes into mature dendritic cells (DCs). It is produced in our dedicated animal-free facility ensuring maximum safety for optimal use in ATMP manufacturing.

General Information

Granulocyte-macrophage colony-stimulating factor (GM-CSF), also known as CSF2, is an important hematopoietic growth factor and immune modulator. It is produced by a variety of cell types including; T cells, macrophages, natural killer cells, endothelial cells and fibroblasts. Its’ role is to promote neutrophil proliferation and maturation.

GM-CSF is used in the cell and gene therapy space for its ability to promote DC differentiation and function as well as macrophage activity. It is considered a critical factor for the development of DC therapies.

GMP Grade

CellGenix GMP Recombinant Human GM-CSF is produced following all applicable GMP guidelines and allows for the safe use in accordance with USP Chapter <1043> and Ph. Eur. General Chapter 5.2.12.

Our GMP cytokines are provided with documented evidence of purity, potency, consistency and stability. In combination with our expert regulatory and technical support this will help simplify your raw material qualification and validation efforts.

name
CellGenix® Recombinant Human Granulocyte-Macrophage Colony-Stimulating Factor
Source
E. coli
Formulation
Lyophilized
ANIMAL-DERIVED COMPONENT-FREE
CellGenix® GMP rh GM-CSF
amount
Order Number
50  µg
1012-050
1 mg
1012-1000
CellGenix® Preclinical rh GM-CSF
amount
Order Number
50  µg
1412-050

CellGenix® rh GM-CSF

Features

  • Produced in our dedicated animal-free facility
  • Compliant to USP Chapter <1043> and Ph. Eur. General Chapter 5.2.12 (GMP)
  • FDA Drug Master File available (GMP)

GMP & Preclinical Grade

  • Seamless transition from preclinical development to ATMP manufacturing

Applications

  • Promotes DC differentiation
  • Increases macrophage activity

Highest GMP Quality Standard

  • High lot-to-lot consistency – save time on revalidations
  • Performance reliability – rely on consistent product performance
  • Highest purity – ensure the safety of your ATMP
  • Extremely low endotoxin levels – improve safety and reproducibility
  • Expert regulatory & technical support – rely on experience

Read more about our GMP Quality

 

Safe │ GMP Compliant │ Reliable

Technical Details

Source
Expressed in E. coli
Description

Human GM-CSF, accession # P04141, Ala18-Glu144

Formulation

Lyophilized from a 0.2 µm-filtered solution containing 1.5 mM potassium phosphate, 8.1 mM sodium phosphate, 2.7 mM potassium chloride and 137 mM sodium chloride, pH 7.5

Both product grades are produced under the same conditions in a GMP facility, ensuring an equal product quality and performance. We offer a more comprehensive QC testing including tighter specifications and documentation for our GMP products: Preclinical vs GMP

 PreclinicalGMP
Molecular weight14.5 kDa14.5 kDa
Purity≥ 95% as determined by SDS-PAGE≥ 97% as determined by SDS-PAGE
Activity≥ 6 x 106 IU/mg, calibrated against NIBSC #88/6468 – 14 x 106 IU/mg, calibrated against NIBSC #88/646
Batch specific activity on CoA
Endotoxin level< 1000 EU/mg≤ 50 EU/mg
Intended useIntended for preclinical ex vivo use. Not intended for human in vivo application.Intended for clinical ex vivo use. Not intended for human in vivo application.

Handling Instructions

Reconstitution

Recommended in sterile water to a final concentration of 250 µg/ml for 50 µg vials or 500 µg/ml for 1 mg vials.

Shipment

Ambient temperature. Please refer to Technote to learn more about our shipment validation procedure.

Expiry

≥ 6 months from date of shipping. Please refer to Certificate of Analysis (CoA) for the exact expiry date.

Storage & Stability

Store lyophilized cytokine at -20°C to -80°C.

Store a 250 µg/ml reconstituted cytokine solution:

• 4 weeks at 2°C to 8°C under sterile conditions after reconstitution. Store in the original container. 

• 4 months at -20°C to -80°C under sterile conditions after reconstitution. Store in 60 µl aliquots in polypropylene cryogenic vials.

Avoid repeated freeze/thaw cycles.

Documents

Data

CellGenix rh GMP GM-CSF has an activity of 8 – 14 × 106 IU/mg

The activity of rh GMP GM-CSF was measured in a cell proliferation assay using the GM-CSF-dependent cell line TF1. It was calibrated against the NIBSC #88/646.

You can find the batch specific activity on the certificate of analysis (CoA).

Regulatory Support

We offer the following to assist you with your regulatory approval process:

  • Comprehensive documentation (e.g. DMFs, Regulatory Support Files, Certificates of Origin)
  • Outstanding QC support (e.g. extensive stability data)
  • The 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 with the international guidelines for raw materials, we are in constant interaction with regulatory authorities worldwide. In this regard, we amongst others helped defining the European guidelines which are outlined in the new general chapter Ph. Eur. monograph 5.2.12.

 

Regulatory Resources

Publications