CellGenix® rh EGF
GMP and Preclinical grade
CellGenix Recombinant Human EGF reliably promotes the expansion of mesenchymal stem cells (MSCs). It in addition promotes the differentiation of embryonic stem cells (ESCs) and induced pluripotent stem cells (iPSCs)-derived hepatoblasts. CellGenix rh EGF is produced in our dedicated animal-free facility ensuring maximum safety for optimal use in ATMP manufacturing.
General Information
Epidermal Growth Factor (EGF) is a growth factor that promotes cell growth, proliferation and differentiation. It is found in a variety of human body fluids.
EGF is used in the cell and gene therapy space for the expansion of bone marrow and adipose tissue derived MSCs, and the generation of stem cell derived hepatocytes.
GMP Grade
CellGenix GMP Recombinant Human EGF is produced following all applicable GMP guidelines and allows for the safe use in accordance with USP Chapter <1043>, Ph. Eur. General Chapter 5.2.12 and ISO Technical Standard 20399.
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 Epidermal Growth Factor
Source
E. coli
Formulation
Lyophilized
ANIMAL-DERIVED COMPONENT-FREE
CellGenix® GMP rh EGF
1 mg
1016-1000
50 µg
1016-050
CellGenix® Preclinical rh EGF
CellGenix® rh EGF
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
- Ex vivo expansion of MSCs
- Differentiation of ESCs and iPSCs into hepatocytes
Highest GMP Quality Standard
- High lot-to-lot consistency – save time and costs 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 EGF, accession # P01133, Asn971-Arg1023
Formulation
Lyophilized from a 0.2 µm-filtered solution containing 25 mM sodium acetate, pH 5.0
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.
| | Preclinical | GMP |
| Molecular weight | 7.2 kDa | 7.2 kDa |
| Purity | ≥ 95% as determined by RP-HPLC | ≥ 97% as determined by RP-HPLC |
| Activity | ≥ 0.5 x 106 IU/mg, calibrated against NIBSC #91/530
Measured in a cell proliferation assay using an EGF-dependent cell line, Balb/3T3 | 0.5 – 2.0 x 106 IU/mg, calibrated against NIBSC #91/530
Measured in a cell proliferation assay using an EGF-dependent cell line, Balb/3T3Batch specific activity on CoA |
| Endotoxin level | < 1000 EU/mg | ≤ 50 EU/mg |
| Intended use | Intended for preclinical ex vivo use. Not intended for therapeutic use. | Intended for clinical ex vivo use. Not intended for human in vivo application. |
Handling Instructions
Reconstitution
Recommended in 0.2% acetic acid 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.
Storage & Stability
Store lyophilized cytokine at -20°C to -80°C.
Store a 250 µg/ml 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.
Data
CellGenix GMP rh EGF has an activity of 0.5 – 2.0 × 106 IU/mg
The activity of GMP rh EGF was measured in a cell proliferation assay using an EGF-dependent cell line , Balb/3T3. It was calibrated against NIBSC #91/530.
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 9-0
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
