CellGenix® rh PDGF-BB
GMP and Preclinical grade
CellGenix Recombinant Human PDGF-BB reliably supports proliferation of mesenchymal stem cells (MSCs) and chondrocytes. CellGenix rh PDGF-BB is produced in our dedicated animal-free facility ensuring maximum safety for optimal use in ATMP manufacturing.
Platelet-derived growth factor-BB (PDGF-BB) is a member of the platelet-derived growth factor family. It is produced by platelets and plays an important role in angiogenesis.
PDGF-BB is used in the cell and gene therapy space for the expansion of bone marrow and adipose tissue derived MSCs and Chondroctyes.
CellGenix GMP Recombinant Human PDGF-BB 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.
CellGenix® Recombinant Human Platelet-Derived Growth Factor-BB
CellGenix® GMP rh PDGF-BB
CellGenix® Preclinical rh PDGF-BB
CellGenix® rh PDGF-BB
- Produced in our dedicated animal-free facility
- Compliant to USP Chapter <1043> and Ph. Eur. General Chapter 5.2.12 (GMP)
GMP & Preclinical Grade
- Seamless transition from preclinical development to ATMP manufacturing
- Expansion of MSCs
- Expansion of chondrocytes
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
Expressed in E. coli
Human PDGF-BB, accession # P01127, Ser82-Thr190
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.
|Molecular weight||24.8 kDa||24.8 kDa|
|Purity||≥ 95% as determined by SDS-PAGE||≥ 97% as determined by SDS-PAGE|
|Activity||≥ 0.4 x 106 IU/mg, calibrated against NIBSC #94/728 Measured in a cell proliferateon assay using a PDGF-BB-dependent cell line, Balb/3T3||1 – 4 x 106 IU/mg, calibrated against NIBSC #94/728 Measured in a cell proliferation assay using a PDGF-BB-dependent cell line, Balb/3T3|
Batch 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.|
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 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.
CellGenix GMP rh PDGF-BB has an activity of 0.5 – 3 × 106 IU/mg
The activity of GMP rh PDGF-BB was measured in a cell proliferation assay using the PDGF-BB-dependent cell line Balb/3T3. It was calibrated against the NIBSC #94/728.
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 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.