CellGenix® rh IL-21
GMP and Preclinical grade
CellGenix Recombinant Human IL-21 reliably promotes the proliferation of T cells and natural killer cells (NK cells) and enhances their cytotoxic function. CellGenix rh IL-21 is produced in our dedicated animal-free GMP facility ensuring maximum safety for optimal use in ATMP manufacturing.
Interleukin-21 (IL-21) is a cytokine that plays an important role in humoral and adaptive immune responses. It stimulates the proliferation of NK cells and multiple T cell subsets, especially cytotoxic T cells. It is produced by activated CD4+ T helper cells and NK T cells.
IL-21 is used in the cell and gene therapy space for the ex vivo expansion of T cells, including CAR T cells and TCR T cells and NK cells.
CellGenix Recombinant Human IL-21 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-21
CellGenix® GMP rh IL-21
CellGenix® Preclinical rh IL-21
CellGenix® rh IL-21
- 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 antigen-specific T cells
- Differentiation of CD4+ T helper cells into Th17 cells
- Enhancement of cytotoxic NK cell function in combination with CellGenix® GMP SCGM Medium
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 IL-21, accession # Q9HBE4, Gln25-Ser155
Lyophilized from 200 µl of a 0.2 µm-filtered solution containing 15 mM sodium acetate and 45 mM sodium chloride, pH 5.5
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||15.4 kDa||15.4 kDa|
|Purity||≥ 95% as determined by SDS-PAGE||≥ 97% as determined by SDS-PAGE|
|Activity||≥ 0.5 x 106 U/mg, calibrated against internal standard “IL-21 RS1” Measured in a cell proliferation assay using an IL-21-dependent cell line, mouse hybridoma B-cells (B9)||0.5 – 1.6 x 106 U/mg, calibrated against internal standard “IL-21 RS1” Measured in a cell proliferation assay using an IL-21-dependent cell line, mouse hybridoma B-cells (B9)|
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.
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 100 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-21 has an activity of 0.5 – 1.6 × 106 IU/mg
The activity of GMP rh IL-21 was measured in a cell proliferation assay using the IL-21-dependent cell line mouse hybridoma B-cells (B9). It was calibrated against the internal standard “IL-21 RS1”.
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 9-0
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.