CellGenix® rh TPO
GMP and Preclinical grade
CellGenix Recombinant Human TPO reliably supports the self-renewal and maintenance of hematopoietic stem cells (HSCs) as well as the differentiation of HSCs into natural killer cells (NK cells). It is also used to differentiate embryonic stem cells (ESCs) and induced pluripotent stem cells (iPSCs) into megakaryocytes. CellGenix rh TPO is produced in our dedicated animal-free facility ensuring maximum safety for optimal use in ATMP manufacturing.
Thrombopoietin (TPO) is a glycoprotein hormone produced by the liver and kidney. It regulates the production of platelets and stimulates the production and differentiation of megakaryocytes.
TPO is used in the cell and gene therapy space for the ex vivo expansion and differentiation of HSCs.
CellGenix GMP Recombinant Human TPO 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 Thrombopoietin
CellGenix® GMP rh TPO
CellGenix® Preclinical rh TPO
CellGenix® rh TPO
- 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
- Expansion of HSCs
- Differentiation of HSCs into NK cells
- Differentiation of ESCs and iPSCs into megakaryocytes
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
Truncated Human TPO, accession # P40225, Ser22-Leu195
Lyophilized from a 0.2 µm-filtered aqueous solution
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||19.6 kDa||19.6 kDa|
|Purity||≥ 95% as determined by SDS-PAGE||≥ 98% as determined by SDS-PAGE|
|Activity||≥ 10 x 106 IU/mg, calibrated against an in-house reference standard||10 – 40 x 106 IU/mg, calibrated against an in-house reference standard|
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.
≥ 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.
CellGenix GMP rh TPO has an activity of 10 – 40 × 106 IU/mg
The activity of GMP rh TPO was measured in a cell proliferation assay using the TPO-dependent cell line MO7e. It was calibrated against an in-house reference standard.
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.
- In vivo Efficacy of umbilical Cord Blood Stem Cell-Derived NK Cells in the treatment of Metastatic Colorectal Cancer
Veluchamy, JP. et al., 2017, Frontiers in Immunology
- Gene therapy in a patient with Sickle Cell disease
Ribeil, JA. et al., 2017, The New England Journal of Medicine
- Large scale production of megakaryocytes from human pluripotent stem cells by chemically defined forward programming
Moreau, T. et al., 2016, Nature communications
- A critical role of CXCR2 PDZ-mediated interactions in endothelial progenitor cell homing and angiogenesis
Hou, Y. et al., 2015, Stem Cell Research & Therapy
- 3′, 4′-Dimethoxyflavone and valproic acid promotes the proliferation of human hematopoietic stem cells.
Kaur, K. et al., 2013, Stem Cell Research & Therapy
- Compound inheritance of a low-frequency regulatory SNP and a rare null mutation in exon-junction complex subunit RBM8A causes TAR syndrome
Albers, CA. et al., 2012, Nature Genetics
- MRI tracking of FePro labeled fresh and cryopreserved long term in vitro expanded human cord blood AC133+ endothelial progenitor cells in rat glioma
Janic, B. et al., 2012, PLoS One
- Clinical-Grade Generation of Active NK Cells from Cord Blood Hematopoietic Progenitor Cells for Immunotherapy Using a Closed-System Culture Process
Spanholtz, J. et al., 2011, PloS One
- p22(phox)-dependent NADPH oxidase activity is required for megakaryocytic differentiation
Sardina, JL. et al., 2010, Cell Death and Differentiation
- Notch-mediated expansion of human cord blood progenitor cells capable of rapid myeloid reconstitution
Delaney, C. et al., 2010, Nature Medicine