CellGenix® rh FGF-2
GMP and Preclinical grade
CellGenix Recombinant Human FGF-2, also known as bFGF, reliable improves proliferation of mesenchymal stem cells (MSCs). It in addition supports proliferation and differentiation of chondrocytes and supports propagation of undifferentiated pluripotent stem cells (PSCs). CellGenix rh FGF-2 is produced in our dedicated animal-free facility ensuring maximum safety for optimal use in ATMP manufacturing.
Fibroblast Growth Factor-2 (FGF-2) is a basic fibroblast growth factor. It amongst others plays an important role in wound healing and tumor development by mediating the formation of new blood vessels.
FGF-2 is used in the cell and gene therapy space for the expansion of bone marrow and adipose tissue derived MSCs.
CellGenix GMP Recombinant Human FGF-2 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.
CellGenix® Recombinant Human Fibroblast Growth Factor-2
CellGenix® GMP rh FGF-2
CellGenix® Preclinical rh FGF-2
CellGenix® rh FGF-2
- Contains neither animal- nor human-derived materials
- 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
- Ex vivo expansion of MSCs
- Propagation and maintenance of undifferentiated PSCs
- Ex vivo expansion of Chondrocytes
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
Expressed in E. coli
Human FGF-2, accession # P090938, Ala135-Ser288
Lyophilized from a 0.2 µm-filtered solution containing 25 mM sodium phosphate, 400 mM sodium chloride, 10 mM glutathione (red.) and 5% mannitol, pH 6.5
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
|Molecular weight||17.3 kDa||17.3 kDa|
|Purity||≥ 95 % as determined by SDS-PAGE||≥ 97 % as determined by SDS-PAGE and RP-HPLC|
|Activity||≥ 0.9 x 106 IU/mg, calibrated against NIBSC #90/712||0.9 – 3 x 106 IU/mg, calibrated against NIBSC #90/712|
Batch specific activity on CoA
|Endotoxin level||< 1000 EU/mg||≤ 50 EU/mg|
|Intended use||Intended 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.|
Recommended in sterile water to a final concentration of 250 µg/ml for 50 µg vials or 500 µg/ml for 1 mg vials.
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 reconstituted cytokine solution:
• 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.
CellGenix GMP rh FGF-2 has an activity of 0.9 – 3.6 × 106 IU/mg
The activity of GMP rh FGF-2 was measured in a cell proliferation assay using the FGF-2-dependent cell line FBHE. It was calibrated against NIBSC #90/712.
You can find the batch specific activity on the certificate of analysis (CoA).
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
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.
- Phase 1-2 pilot clinical trial in patients with decompensated liver cirrhosis treated with bone marrow-derived endothelial progenitor cells
D`Avola, D. et al., 2016, Translational Research
- Intramyocardial transplantation of mesenchymal stromal cells for chronic myocardial ischemia and impaired left ventricular function: Results of the MESAMI 1 pilot trial
Guijarro D. et al., 2016, International Journal of Cardiology
- Autologous chondrocyte implantation in children and adolescents
Schmal, H. et al., 2012, Knee Surgery, Sports Traumatology, Arthroscopy
- In vitro cell quality of articular chondrocytes assigned for autologous implantation in dependence of specific patient characteristics
Pestka, JM. et al., 2011, Archives of Orthopaedic and Trauma Surgery