CellGenix® rh IL-7
GMP and Preclinical grade
CellGenix Recombinant Human IL-7 supports the survival, proliferation and differentiation of T cells and enhances survival of natural killer cells (NK cells). CellGenix rh IL-7 is produced in our dedicated animal-free facility ensuring maximum safety for optimal use in ATMP manufacturing.
Interleukin-7 (IL-7) is a cytokine that promotes the differentiation of pluripotent hematopoietic stem cells (HSCs) into lymphoid progenitor cells. Furthermore it supports proliferation of various cells in the lymphoid lineage (B cells, T cells and NK cells). It is secreted mainly by stromal cells in the bone marrow and thymus.
IL-7 is used in the cell and gene therapy space for the ex vivo expansion of genetically modified T cells, such as CAR T cells, and differentiation of induced pluripotent stem cells (iPSCs) into T cells. It is in addition used to differentiate cord blood derived hematopoietic stem cells (HSCs/CD34+) into NK cells.
CellGenix Recombinant Human IL-7 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 Interleukin-7
CellGenix® GMP rh IL-7
CellGenix® Preclinical rh IL-7
CellGenix® rh IL-7
- 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 T cells
- Promotes the differentiation of iPSCs to T cells
- Promotes the differentiation of HSCs to NK cells
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 Interleukin-7, accession # P13232, Asp26-His177
Lyophilized from 200 µl of a 0.2 µm-filtered solution containing 25 mM sodium phosphate, 150 mM sodium chloride and 0.1 % polysorbate 20, 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||18.3 kDa||18.3 kDa|
|Purity||≥ 95% as determined by SDS-PAGE||≥ 97% as determined by SDS-PAGE|
|Activity||≥ 50 x 106 IU/mg, calibrated against NIBSC #90/530 Measured in a cell proliferation assay using an IL-7-dependent cell line, IxN/2b||50 – 200 x 106 IU/mg, calibrated against NIBSC #90/530 Measured in a cell proliferation assay using an IL-7-dependent cell line, IxN/2b|
Batch specific activity on CoA
|Endotoxin level||< 25 EU/mg||≤ 25 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.
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 IL-7 has an activity of 50 – 200 × 106 IU/mg
The activity of GMP rh IL-7 was measured in a cell proliferation assay using the IL-7-dependent cell line IxN/2b. It was calibrated against NIBSC #90/530.
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.
- 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
- Lentivirus-induced “Smart” dendritic cells: Pharmacodynamics and GMP-compliant production for immunotherapy against TRP2-positive melanoma
Sundarasetty, BS. et al., 2015, Gene Therapy
- IL-7 Abrogates the Immunosuppressive Function of Human Double-Negative T Cells by Activating akt/mTOR Signaling
Allgäuer, A. et al., 2015, Journal of Immunology
- Antigen-specific activation and cytokine-faciliated expansion of naive, human CD8+ T cells
Wölfl, M., Greenberg, PD., 2014, Nature Protocols
- Isolation of Highly Suppressive CD25+FoxP3+ T Regulatory Cells from G-CSF-Mogilized Donors with Retention of Cytotoxic Anti-Viral CTLs: Application for Multi-Functional Immunotherapy Post Stem Cell Transplantation
Samuel ER. et al., 2014, Plos One
- Natural killer cells generated from cord blood hematopoietic progenitor cells efficiently target bone marrow-residing human leukemia cells in NOD/SCID/IL2Rg(null) mice
Cany, J. et al., 2013, 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